Trial Outcomes & Findings for A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS (NCT NCT05424380)
NCT ID: NCT05424380
Last Updated: 2025-03-25
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to 11.3 weeks
Results posted on
2025-03-25
Participant Flow
The study conducted in a staged approach consisting of 2 parts. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study.
A total of 18 participants were enrolled in Part 1 of the study.
Participant milestones
| Measure |
Part 1: Cohort 1: GSK3745417 12.5 ug Followed by 25 ug Followed by 50 ug
Participants with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) received GSK3745417 12.5 microgram (ug), powder for solution as intravenous (IV) injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 25 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 50 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 2: GSK3745417 25 ug Followed by 50 ug Followed by 100 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 25 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 50 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 100 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 3: GSK3745417 50 ug Followed by 100 ug Followed by 200 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 50 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 100 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 200 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 4: GSK3745417 100 ug Followed by 200 ug Followed by 300 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 100 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 200 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 5: GSK3745417 200 ug Followed by 300 ug Followed by 300 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 200 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 300 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 2: GSK3745417
Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study.
|
|---|---|---|---|---|---|---|
|
Part 1: Cohort 1: 12.5 ug (Days 1 to 28)
STARTED
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 12.5 ug (Days 1 to 28)
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 12.5 ug (Days 1 to 28)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 25 ug (Days 29 to 57)
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 25 ug (Days 29 to 57)
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 25 ug (Days 29 to 57)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 50 ug (Days 58 to 86)
STARTED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 50 ug (Days 58 to 86)
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 50 ug (Days 58 to 86)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 25 ug (Days 1 to 28)
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 25 ug (Days 1 to 28)
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 25 ug (Days 1 to 28)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 50 ug (Days 29 to 57)
STARTED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 50 ug (Days 29 to 57)
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 50 ug (Days 29 to 57)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 100 ug (Days 58 to 86)
STARTED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 100 ug (Days 58 to 86)
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 100 ug (Days 58 to 86)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 50 ug (Days 1 to 28)
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 50 ug (Days 1 to 28)
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 50 ug (Days 1 to 28)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 100 ug (Days 29 to 57)
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 100 ug (Days 29 to 57)
COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 100 ug (Days 29 to 57)
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 200 ug (Days 58 to 86)
STARTED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 200 ug (Days 58 to 86)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 200 ug (Days 58 to 86)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 4:100 ug (Days 1 to 28)
STARTED
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Part 1: Cohort 4:100 ug (Days 1 to 28)
COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 1: Cohort 4:100 ug (Days 1 to 28)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 200 ug (Days 29 to 57)
STARTED
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 1: Cohort 4: 200 ug (Days 29 to 57)
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 200 ug (Days 29 to 57)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 300 ug (Days 58 to 86)
STARTED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 300 ug (Days 58 to 86)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 4: 300 ug (Days 58 to 86)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 5: 200 ug (Days 1 to 28)
STARTED
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Part 1: Cohort 5: 200 ug (Days 1 to 28)
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Cohort 5: 200 ug (Days 1 to 28)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 29 to 57)
STARTED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 29 to 57)
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 29 to 57)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 58 to 86)
STARTED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 58 to 86)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 58 to 86)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2 (Up to 49 Weeks)
STARTED
|
0
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0
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0
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0
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0
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0
|
|
Part 2 (Up to 49 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 49 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Cohort 1: GSK3745417 12.5 ug Followed by 25 ug Followed by 50 ug
Participants with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) received GSK3745417 12.5 microgram (ug), powder for solution as intravenous (IV) injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 25 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 50 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 2: GSK3745417 25 ug Followed by 50 ug Followed by 100 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 25 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 50 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 100 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 3: GSK3745417 50 ug Followed by 100 ug Followed by 200 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 50 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 100 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 200 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 4: GSK3745417 100 ug Followed by 200 ug Followed by 300 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 100 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 200 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 5: GSK3745417 200 ug Followed by 300 ug Followed by 300 ug
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 200 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 300 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 2: GSK3745417
Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study.
|
|---|---|---|---|---|---|---|
|
Part 1: Cohort 1: 12.5 ug (Days 1 to 28)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 25 ug (Days 29 to 57)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 1: 50 ug (Days 58 to 86)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 25 ug (Days 1 to 28)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 2: 100 ug (Days 58 to 86)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 100 ug (Days 29 to 57)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 100 ug (Days 29 to 57)
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 3: 200 ug (Days 58 to 86)
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Cohort 4:100 ug (Days 1 to 28)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 200 ug (Days 29 to 57)
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 4: 300 ug (Days 58 to 86)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Cohort 5: 200 ug (Days 1 to 28)
Death
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Part 1: Cohort 5: 200 ug (Days 1 to 28)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Cohort 5: 300 ug (Days 58 to 86)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
Baseline characteristics by cohort
| Measure |
Part 1: Cohort 1: GSK3745417 12.5 ug Followed by 25 ug Followed by 50 ug
n=4 Participants
Participants with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) received GSK3745417 12.5 microgram (ug), powder for solution as intravenous (IV) injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 25 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 50 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 2: GSK3745417 25 ug Followed by 50 ug Followed by 100 ug
n=3 Participants
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 25 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 50 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 100 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 3: GSK3745417 50 ug Followed by 100 ug Followed by 200 ug
n=3 Participants
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 50 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 100 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 200 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 4: GSK3745417 100 ug Followed by 200 ug Followed by 300 ug
n=3 Participants
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 100 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 200 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 1: Cohort 5: GSK3745417 200 ug Followed by 300 ug Followed by 300 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received GSK3745417 200 ug, powder for solution as IV injection from Days 1 to 28 (Cycle 1) followed by GSK3745417 300 ug, powder for solution as IV injection from Days 29 to 57 (Cycle 2); further followed by GSK3745417 300 ug, powder for solution as IV injection from Days 58 to 86 (Cycle 3). Each cycle was of 28 days.
|
Part 2: GSK3745417
Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.0 YEARS
STANDARD_DEVIATION 17.11 • n=99 Participants
|
71.3 YEARS
STANDARD_DEVIATION 4.73 • n=107 Participants
|
69.7 YEARS
STANDARD_DEVIATION 4.04 • n=206 Participants
|
53.7 YEARS
STANDARD_DEVIATION 15.31 • n=7 Participants
|
67.0 YEARS
STANDARD_DEVIATION 7.07 • n=31 Participants
|
—
|
60.8 YEARS
STANDARD_DEVIATION 14.69 • n=3 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
—
|
8 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
—
|
10 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
—
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
—
|
18 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
—
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 11.3 weeksPopulation: Safety Population included all participants who took at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment-emergent (TE) Adverse Events (AEs) and TE Serious AEs (SAEs)
TESAEs
|
4 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Treatment-emergent (TE) Adverse Events (AEs) and TE Serious AEs (SAEs)
TEAEs
|
4 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 11.3 weeksPopulation: Safety Population
AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0): Grade(G) 1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TESAEs, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TESAEs, Grade 5
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TEAEs, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TEAEs, Grade 2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TEAEs, Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TEAEs, Grade 4
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TEAEs, Grade 5
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TESAEs, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TESAEs, Grade 3
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With TEAEs and TESAEs by Severity Grades
TESAEs, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: DLT-evaluable Population included all participants who took at least 1 dose of study intervention and followed for the DLT observation period or were withdrawn within the DLT observation period due to meeting the DLT criteria.
An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and attributed (definitely, probably, or possibly) to the study intervention and meets at least 1 of the criteria listed below. Criteria for DLT included Grade(G)3 or 4 Cytokine Release Syndrome (CRS); G3 or 4 tumor lysis syndrome (TLS) that cannot be managed/ is not resolved within 72 hours (h); Liver Toxicity included Alanine aminotransferase (ALT)\>=3\* upper limit of normal (ULN), plus bilirubin\>=2\* ULN (\>35 percent \[%\] direct) or plus international normalized ratio (INR)\>1.5 (Possible Hy's law); G\>=3 non-hematologic toxicity of any duration; G\>=3 immune-related toxicity that does not resolve to G\<=1 or Baseline within 8 days despite adequate immune suppressive therapy. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 11.3 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Withdrawals Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 84Population: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Overall response rate (ORR) defined as the percentage of participants with a complete remission (CR), CR with incomplete platelet recovery (CRp), incomplete count recovery (CRi), or a partial remission (PR) as per response criteria for AML and HR-MDS. CR=The participant must achieve a morphologic leukemia-free state (\<= 5% blasts) and have no evidence of extramedullary disease. The participant must be free of all symptoms related to leukemia, have an absolute neutrophil count \>= 1\*10\^9/Liter (L) and platelet count \>=100\*10\^9/L, and be transfusion independent. CRp: Marrow response as per CR but platelet count \<100 × 10\^9/L. CRi: Marrow response as per CR but platelet count \<100\*10\^9/L or neutrophil count \<1\*10\^9/L. PR=A decrease from Baseline of at least 50% in the number of bone marrow blasts, to between 5% and 25% of the bone marrow aspirate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 49 weeksPopulation: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 49 weeksPopulation: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE (version 5.0): G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and attributed (definitely, probably, or possibly) to the study intervention and meets at least 1 of the criteria listed below. Criteria for DLT included Grade(G)3 or 4 Cytokine Release Syndrome (CRS); G3 or 4 TLS that cannot be managed/ is not resolved within 72 hours (h); Liver Toxicity included ALT\>=3\*upper limit of normal (ULN), plus bilirubin\>=2\*ULN (\>35% direct) or plus international normalized ratio (INR)\>1.5 (Possible Hy's law); G\>=3 non-hematologic toxicity of any duration; G\>=3 immune-related toxicity that does not resolve to G\<=1 or Baseline within 8 days despite adequate immune suppressive therapy. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 49 weeksPopulation: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population included all participants from the Safety Analysis Set for whom a PK sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 12.5 µg, 25 ug, 50 µg and 200 µg
DAY 1
|
4.0437 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 63.1268
|
5.3407 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18.6391
|
11.4244 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 15.6862
|
49.8671 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 25.7641
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 12.5 µg, 25 ug, 50 µg and 200 µg
DAY 5
|
3.3922 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 76.7856
|
9.9633 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50.2486
|
11.7986 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 12.9766
|
55.8182 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32.3703
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 100 µg
DAY 12
|
37.9700 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50.5418
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 100 µg
DAY 1
|
23.4043 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 34.9860
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 100 µg
DAY 5
|
27.9947 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 33.7584
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 100 µg
DAY 8
|
20.7000 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 300 µg
DAY 1
|
60.0576 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18.6563
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 300 µg
DAY 5
|
83.6227 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 13.7291
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Maximum Concentration (Cmax) Following Administration of GSK3745417 300 µg
DAY 8
|
95.6000 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
21.7427 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 57.6324
|
18.3426 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 105.4447
|
39.7661 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 86.7711
|
115.7833 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 86.2087
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
24.5192 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 70.8547
|
53.4229 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 75.0209
|
40.3425 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 46.5663
|
269.2527 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 97.8566
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 100 µg
DAY 1
|
73.7605 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 102.0968
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 100 µg
DAY 5
|
129.1817 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 133.3992
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 100 µg
DAY 8
|
88.3060 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 100 µg
DAY 12
|
246.3285 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 273.1186
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 300 µg
DAY 1
|
111.0980 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.4746
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 300 µg
DAY 5
|
156.7682 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.7702
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve AUC(0-t) Following Administration of GSK3745417 300 µg
DAY 8
|
177.0957 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
22.0086 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 58.5871
|
18.6671 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 101.4660
|
40.4989 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 86.3765
|
116.0595 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 86.0517
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
24.4250 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 71.8245
|
53.6275 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 75.3947
|
40.5395 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 46.3785
|
267.9373 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 98.1167
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 100 µg
DAY 1
|
75.4673 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 103.4499
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 100 µg
DAY 5
|
129.6654 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 134.9177
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 100 µg
DAY 8
|
88.4344 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 100 µg
DAY 12
|
247.2046 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 272.2710
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 300 µg
DAY 1
|
111.2544 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.7235
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 300 µg
DAY 5
|
157.0654 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.6207
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC (0-tau) Following Administration of GSK3745417 300 µg
DAY 8
|
177.2807 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
24.1814 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 58.7275
|
19.7396 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 111.3832
|
44.1762 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 110.0662
|
124.8946 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 103.5148
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
32.1932 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 85.8221
|
61.4040 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 89.9314
|
42.2109 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.0113
|
302.1566 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 119.5787
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 100 µg
DAY 1
|
82.4501 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 122.0638
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 100 µg
DAY 5
|
149.6791 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 171.2285
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 100 µg
DAY 8
|
91.6906 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 100 µg
DAY 12
|
92.8915 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 300 µg
DAY 1
|
113.4262 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.3464
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 300 µg
DAY 5
|
161.3749 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.9753
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: AUC(0-infinity) Following Administration of GSK3745417 300 µg
DAY 8
|
179.2585 Hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
0.0958 1/hour
Geometric Coefficient of Variation 14.0287
|
0.1879 1/hour
Geometric Coefficient of Variation 122.9400
|
0.1614 1/hour
Geometric Coefficient of Variation 100.3767
|
0.1106 1/hour
Geometric Coefficient of Variation 98.3724
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
0.0564 1/hour
Geometric Coefficient of Variation 23.4595
|
0.0902 1/hour
Geometric Coefficient of Variation 41.2921
|
0.1233 1/hour
Geometric Coefficient of Variation 7.5634
|
0.0924 1/hour
Geometric Coefficient of Variation 36.4027
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 100 µg
DAY 1
|
0.1400 1/hour
Geometric Coefficient of Variation 114.8419
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 100 µg
DAY 5
|
0.0862 1/hour
Geometric Coefficient of Variation 43.9385
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 100 µg
DAY 8
|
0.1300 1/hour
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 100 µg
DAY 12
|
0.0603 1/hour
Geometric Coefficient of Variation 100.8393
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 300 µg
DAY 1
|
0.0978 1/hour
Geometric Coefficient of Variation 39.1392
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 300 µg
DAY 5
|
0.1237 1/hour
Geometric Coefficient of Variation 39.1510
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Elimination Rate Constant (Lambda Z) Following Administration of GSK3745417 300 µg
DAY 8
|
0.1512 1/hour
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
7.2332 Hour (h)
Geometric Coefficient of Variation 14.0287
|
3.6895 Hour (h)
Geometric Coefficient of Variation 122.9400
|
4.2938 Hour (h)
Geometric Coefficient of Variation 100.3767
|
6.2658 Hour (h)
Geometric Coefficient of Variation 98.3724
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
12.2931 Hour (h)
Geometric Coefficient of Variation 23.4595
|
7.6835 Hour (h)
Geometric Coefficient of Variation 41.2921
|
5.6202 Hour (h)
Geometric Coefficient of Variation 7.5634
|
7.4977 Hour (h)
Geometric Coefficient of Variation 36.4027
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 100 µg
DAY 1
|
4.9494 Hour (h)
Geometric Coefficient of Variation 114.8419
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 100 µg
DAY 5
|
8.0420 Hour (h)
Geometric Coefficient of Variation 43.9385
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 100 µg
DAY 8
|
5.3318 Hour (h)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 100 µg
DAY 12
|
11.4948 Hour (h)
Geometric Coefficient of Variation 100.8393
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 300 µg
DAY 1
|
7.0877 Hour (h)
Geometric Coefficient of Variation 39.1392
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 300 µg
DAY 5
|
5.6013 Hour (h)
Geometric Coefficient of Variation 39.1510
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 300 µg
DAY 8
|
4.5845 Hour (h)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
0.5169 Liter/hour (L/h)
Geometric Coefficient of Variation 58.7275
|
1.2669 Liter/hour (L/h)
Geometric Coefficient of Variation 110.9895
|
1.1313 Liter/hour (L/h)
Geometric Coefficient of Variation 109.9904
|
1.5982 Liter/hour (L/h)
Geometric Coefficient of Variation 103.1281
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
0.3883 Liter/hour (L/h)
Geometric Coefficient of Variation 85.8221
|
0.4090 Liter/hour (L/h)
Geometric Coefficient of Variation 89.8847
|
1.1870 Liter/hour (L/h)
Geometric Coefficient of Variation 48.4302
|
0.8532 Liter/hour (L/h)
Geometric Coefficient of Variation 140.7702
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 100 µg
DAY 1
|
1.2121 Liter/hour (L/h)
Geometric Coefficient of Variation 121.9357
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 100 µg
DAY 5
|
0.6681 Liter/hour (L/h)
Geometric Coefficient of Variation 171.2285
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 100 µg
DAY 8
|
1.0906 Liter/hour (L/h)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 100 µg
DAY 12
|
0.2935 Liter/hour (L/h)
Geometric Coefficient of Variation 532.2277
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 300 µg
DAY 1
|
2.6516 Liter/hour (L/h)
Geometric Coefficient of Variation 17.5162
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 300 µg
DAY 5
|
1.8769 Liter/hour (L/h)
Geometric Coefficient of Variation 22.2726
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Systemic Clearance of Parent Drug (CL) Following Administration of GSK3745417 300 µg
DAY 8
|
1.6736 Liter/hour (L/h)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 5Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=5 Participants
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 Participants
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 5
|
7.9543 Liter (L)
Geometric Coefficient of Variation 44.7917
|
4.0818 Liter (L)
Geometric Coefficient of Variation 48.7367
|
6.7901 Liter (L)
Geometric Coefficient of Variation 18.9568
|
6.0176 Liter (L)
Geometric Coefficient of Variation 30.5236
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 12.5 µg, 25 µg, 50 µg and 200 µg
DAY 1
|
5.1242 Liter (L)
Geometric Coefficient of Variation 62.5343
|
6.1162 Liter (L)
Geometric Coefficient of Variation 15.1427
|
6.2318 Liter (L)
Geometric Coefficient of Variation 23.2325
|
7.2915 Liter (L)
Geometric Coefficient of Variation 35.8656
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30 and 45 minutes, 1, 2, 4, 6, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 12 and 24 hours on Day 8; Pre-dose, 5 minutes, 4, 8 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=8 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 100 µg
DAY 12
|
5.4797 Liter (L)
Geometric Coefficient of Variation 38.0866
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 100 µg
DAY 1
|
6.8614 Liter (L)
Geometric Coefficient of Variation 41.4133
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 100 µg
DAY 5
|
6.2891 Liter (L)
Geometric Coefficient of Variation 42.2982
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 100 µg
DAY 8
|
7.0024 Liter (L)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 1; Pre-dose, 5 minutes, 1, 4, 8, 12, 24 hours on Day 5; Pre-dose, 5 minutes, 4, 8, 24 hours on Day 8Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
| Measure |
Part 1: GSK3745417 12.5 ug
n=2 Participants
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
|---|---|---|---|---|---|---|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 300 µg
DAY 1
|
7.9354 Liter (L)
Geometric Coefficient of Variation 16.5438
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 300 µg
DAY 5
|
6.6325 Liter (L)
Geometric Coefficient of Variation 29.8240
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Volume of Distribution (V) Following Administration of GSK3745417 300 µg
DAY 8
|
4.5465 Liter (L)
Geometric Coefficient of Variation NA
NA indicates data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 49 weeksPopulation: Safety Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment. AESI includes events that were immune-related or related to Cytokine Release Syndrome or tumor lysis syndrome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5, 15, 30, 45 minutes, 1, 2, 4, 6, 8, 12 and 24 hours on Day 1; Predose on Day 4; Pre-dose and 5 minutes, 4, 8, 24 hours on Day 5; Predose and 4, 8, 12 and 24 hours on Day 8; Pre-dose, 1, 4, 8, 12 and 24 hours on Day 12Population: Pharmacokinetic (PK) Population. No participants were enrolled in Part 2 of the study. Hence, data was not collected for Part 2 of the study.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3745417.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: GSK3745417 12.5 ug
Serious events: 4 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: GSK3745417 25 ug
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Part 1: GSK3745417 50 ug
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 1: GSK3745417 100 ug
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Part 1: GSK3745417 200 ug
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Part 1: GSK3745417 300 ug
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Part 2: GSK3745417
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
Part 2: GSK3745417
Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Hepatic infection
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
Other adverse events
| Measure |
Part 1: GSK3745417 12.5 ug
n=4 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 12.5 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 25 ug
n=6 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 25 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 50 ug
n=6 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 50 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 100 ug
n=8 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 100 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 200 ug
n=8 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 200 ug GSK3745417 powder for solution as IV injection.
|
Part 1: GSK3745417 300 ug
n=2 participants at risk
Participants with relapsed or refractory AML and HR-MDS received 300 ug GSK3745417 powder for solution as IV injection.
|
Part 2: GSK3745417
Participants in Part 2 with relapsed or refractory AML and HR-MDS were planned to receive GSK3745417 starting at the maximum tolerated dose determined from Part 1 of the study.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
General disorders
Asthenia
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
100.0%
2/2 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Investigations
Transaminases increased
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/6 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/8 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
0.00%
0/2 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
—
0/0 • All-cause mortality, treatment emergent (TE) non-serious adverse events (Non-SAEs) and TE serious adverse events (TESAEs) were collected up to 11.3 weeks in Part 1 of the study.
Safety Population included all participants who take at least 1 dose of study intervention. This study was terminated due to termination of asset after Part 1. Hence, no participants were enrolled in Part 2 of the study and data was not collected for Part 2 of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER