Trial Outcomes & Findings for Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors (NCT NCT03447314)
NCT ID: NCT03447314
Last Updated: 2024-09-23
Results Overview
An adverse event 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. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Up to 27 months
Results posted on
2024-09-23
Participant Flow
This was a non-randomized, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors.
Total 54 participants were enrolled in the study. GSK1795091 150 nanograms (ng), 200 and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to manufacturing issue. Part 2 was not initiated.
Participant milestones
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 2a: GSK1795091 + 24 mg GSK3174998
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
|
Part 2b: GSK1795091 + 80 mg GSK3359609
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
|
Part 2c: GSK1795091 + 200 mg Pembrolizumab
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1 (Up to 47 Months and 13 Days)
STARTED
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9
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6
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9
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4
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2
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6
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7
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6
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0
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Part 1 (Up to 47 Months and 13 Days)
COMPLETED
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2
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1
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2
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0
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1
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0
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2
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0
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2
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3
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
NOT COMPLETED
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7
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5
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7
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4
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1
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6
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3
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5
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3
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0
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0
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0
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0
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0
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0
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Part 2 (Up to 47 Months and 13 Days)
STARTED
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0
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0
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0
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0
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0
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0
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0
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Part 2 (Up to 47 Months and 13 Days)
COMPLETED
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0
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0
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0
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0
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0
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Part 2 (Up to 47 Months and 13 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 2a: GSK1795091 + 24 mg GSK3174998
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
|
Part 2b: GSK1795091 + 80 mg GSK3359609
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
|
Part 2c: GSK1795091 + 200 mg Pembrolizumab
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1 (Up to 47 Months and 13 Days)
Death
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6
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5
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4
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3
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1
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4
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2
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0
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0
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0
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4
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3
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0
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0
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0
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
Withdrawal by Subject
|
1
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0
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1
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0
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0
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1
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
Disease progression
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
Lost to Follow-up
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
Reason for discontinuation was not recorded in the case report form
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Up to 47 Months and 13 Days)
Investigator discretion
|
0
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0
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0
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1
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 2a: GSK1795091 + 24 mg GSK3174998
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
|
Part 2b: GSK1795091 + 80 mg GSK3359609
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
|
Part 2c: GSK1795091 + 200 mg Pembrolizumab
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Customized
19 - 64 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
37 Participants
n=667 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
17 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
28 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
26 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
46 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Up to 27 monthsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
An adverse event 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. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)
TEAEs
|
9 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)
STEAEs
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 27 monthsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
An adverse event 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. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 42 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
An adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of \>7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to \<=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) \>=5 times upper limit of normal (ULN), ALT \>=3 times ULN persists for \>=4 weeks, ALT \>=3 times ULN and bilirubin \>=2 times ULN (\>35 percent \[%\] direct bilirubin), ALT \>=3 times ULN and international normalized ratio (INR) \>1.5, ALT \>=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
An adverse event 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. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With TEAEs Leading to Discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
An adverse event 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. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
An adverse event 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. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
An adverse event 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. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1: Pre-dose) and up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range \[LNR\]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1: Pre-dose) and up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1: Pre-dose) and up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Blood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1: Pre-dose) and up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Blood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Urine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Urine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (\>140 and \<161 millimeter of mercury\[mmHg\]), Category 2 (\>=161 and \<181 mmHg), Category3 (\>=181 mmHg); DBP: Category1 (\>90 and \<101 mmHg), Category 2 (\>=101 and \<111 mmHg), Category 3 (\>=111 mmHg); PR: Category 1 (\>101 and \<116 beats per minutes\[bpm\]), Category 2 (\>=116 and \<131 bpm), Category 3 (\>=131 bpm); BT: Category 1 (\>38.0 and \<38.6 degrees Celsius), Category 2 (\>=38.6 and \<39.1 degrees Celsius), Category 3 (\>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Any increase, SBP
|
7 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Any increase, Pulse rate
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Any increase, Body temperature
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Any increase, DBP
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Vital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as \<80 mmHg decrease from Baseline; DBP: decrease defined as Category (\<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (\<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria
Any decrease, SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria
Any decrease, Pulse rate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria
Any decrease, DBP
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Vital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (\>450 milliseconds \[msec\]), Grade 2 (\>480 msec), Grade 3 (\>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=3 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
12-lead ECG was planned to be performed to measure QTcF interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Objective Response Rate
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Disease Control Rate
|
44.4 Percentage of participants
|
33.3 Percentage of participants
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
14.3 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, time to response could not be calculated as no participants had a confirmed CR or PR with in these arms.
Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=1 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=2 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Response
|
5.6 Months
Interval 5.6 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 Months
Interval 1.6 to 2.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, duration of response could not be calculated as no participants had a confirmed CR or PR with in these arms.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=1 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=2 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Duration of Response
|
13.73 Months
Interval 13.73 to 13.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Months
Interval 16.82 to
The final event experienced by participants within the treatment arm occurred in the first 50% of survival times. Hence, median and third-quartile could not be derived.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.
Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. PFS was determined according to RECIST version 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Progression-free Survival
|
2.79 Months
Interval 2.64 to 5.13
|
3.29 Months
Interval 2.46 to 3.61
|
2.60 Months
Interval 2.0 to 7.46
|
2.25 Months
Interval 1.45 to 3.96
|
NA Months
Progression-free Survival could not be calculated as no participants had an event in Part 1a: 250ng GSK1795091 + 24mg GSK3174998 arm.
|
2.28 Months
Interval 1.91 to 2.79
|
1.41 Months
Interval 1.15 to 2.46
|
—
|
—
|
—
|
2.22 Months
Interval 1.91 to 2.43
|
2.37 Months
Interval 2.33 to 19.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest by RECIST v 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.
Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Overall Survival
|
9.03 Months
Interval 6.29 to
The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.
|
7.75 Months
Interval 3.61 to 9.03
|
16.69 Months
Interval 8.03 to
The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.
|
6.72 Months
Interval 3.2 to 9.86
|
11.14 Months
Interval 11.14 to 11.14
|
4.48 Months
Interval 3.15 to 8.38
|
2.89 Months
Interval 2.37 to
The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.
|
—
|
—
|
—
|
3.91 Months
Interval 2.66 to
The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.
|
NA Months
Interval 6.08 to
The final event experienced by participants within the treatment arm occurred in the first 50% of survival times. Hence, median and third-quartile could not be derived.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. Pharmacokinetic (PK) Population consisted of all participants from the All Treated population for whom a PK sample was obtained, analyzed, measurable, and valid.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: Pre-dose, n=9,5,9,4,2
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: 10 minutes, n=7,5,9,4,2
|
3.960 Picogram per milliliter
Interval 0.0 to 5.8
|
4.920 Picogram per milliliter
Interval 4.0 to 11.9
|
28.800 Picogram per milliliter
Interval 5.59 to 53.4
|
56.330 Picogram per milliliter
Interval 43.6 to 68.05
|
82.175 Picogram per milliliter
Interval 64.97 to 99.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: 2 hours, n=8,5,9,4,2
|
1.580 Picogram per milliliter
Interval 0.0 to 4.02
|
4.090 Picogram per milliliter
Interval 2.49 to 5.92
|
29.200 Picogram per milliliter
Interval 2.87 to 48.8
|
57.195 Picogram per milliliter
Interval 35.97 to 63.79
|
62.285 Picogram per milliliter
Interval 57.57 to 67.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: 6 hours, n=8,3,9,4,1
|
0.000 Picogram per milliliter
Interval 0.0 to 2.82
|
3.470 Picogram per milliliter
Interval 2.5 to 4.66
|
25.700 Picogram per milliliter
Interval 0.0 to 40.2
|
46.040 Picogram per milliliter
Interval 32.61 to 64.3
|
57.180 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: 24 hours, n=8,5,9,4,2
|
0.000 Picogram per milliliter
Interval 0.0 to 2.68
|
2.190 Picogram per milliliter
Interval 0.0 to 3.7
|
15.800 Picogram per milliliter
Interval 0.0 to 29.3
|
35.265 Picogram per milliliter
Interval 27.09 to 44.1
|
39.120 Picogram per milliliter
Interval 32.73 to 45.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 8: 4 hours, n=8,5,7,2,1
|
3.190 Picogram per milliliter
Interval 0.0 to 6.8
|
3.790 Picogram per milliliter
Interval 0.0 to 5.03
|
16.000 Picogram per milliliter
Interval 0.0 to 37.4
|
61.830 Picogram per milliliter
Interval 54.29 to 69.37
|
65.030 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 15: Pre-dose, n=9,3,9,2,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.99
|
4.975 Picogram per milliliter
Interval 4.73 to 5.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 15: 10 minutes, n=8,4,8,3,0
|
5.255 Picogram per milliliter
Interval 3.4 to 14.5
|
5.120 Picogram per milliliter
Interval 4.35 to 8.96
|
35.625 Picogram per milliliter
Interval 7.96 to 53.4
|
57.570 Picogram per milliliter
Interval 46.52 to 76.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 15: 4 hours, n=9,3,6,3,0
|
2.830 Picogram per milliliter
Interval 0.0 to 7.24
|
4.210 Picogram per milliliter
Interval 2.75 to 5.02
|
25.675 Picogram per milliliter
Interval 3.15 to 51.3
|
50.950 Picogram per milliliter
Interval 43.71 to 62.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 15: 24 hours, n=9,3,8,3,0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.43
|
3.050 Picogram per milliliter
Interval 2.36 to 3.43
|
18.970 Picogram per milliliter
Interval 0.0 to 34.1
|
41.770 Picogram per milliliter
Interval 36.87 to 50.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 22: Pre-dose, n=9,3,7,3,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.6
|
4.450 Picogram per milliliter
Interval 4.21 to 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 57: Pre-dose, n=6,3,6,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
1.215 Picogram per milliliter
Interval 0.0 to 24.77
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 57: 10 minutes, n=4,3,4,1,0
|
6.400 Picogram per milliliter
Interval 3.03 to 8.94
|
7.470 Picogram per milliliter
Interval 6.08 to 18.2
|
32.600 Picogram per milliliter
Interval 6.87 to 41.31
|
60.090 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 57: 24 hours, n=6,4,6,2,0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.55
|
2.665 Picogram per milliliter
Interval 2.41 to 11.6
|
16.595 Picogram per milliliter
Interval 0.0 to 26.6
|
51.390 Picogram per milliliter
Interval 45.48 to 57.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 64: Pre-dose, n=4,4,4,1,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
3.040 Picogram per milliliter
Interval 0.0 to 46.2
|
15.300 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 64: 10 minutes, n=5,4,3,2,0
|
3.340 Picogram per milliliter
Interval 0.0 to 4.18
|
7.055 Picogram per milliliter
Interval 4.95 to 20.6
|
26.700 Picogram per milliliter
Interval 12.0 to 42.1
|
75.045 Picogram per milliliter
Interval 74.38 to 75.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 78: 10 minutes, n=5,3,4,2,0
|
3.980 Picogram per milliliter
Interval 2.1 to 10.5
|
10.100 Picogram per milliliter
Interval 6.8 to 24.8
|
22.700 Picogram per milliliter
Interval 5.48 to 45.2
|
72.215 Picogram per milliliter
Interval 67.82 to 76.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 162: 10 minutes, n=1,0,0,0,0
|
3.450 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 498: 10 minutes, n=1,0,0,0,0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 1: 4 hours, n=8,5,9,4,2
|
3.680 Picogram per milliliter
Interval 0.0 to 4.41
|
3.680 Picogram per milliliter
Interval 2.29 to 5.67
|
27.300 Picogram per milliliter
Interval 2.11 to 46.9
|
47.315 Picogram per milliliter
Interval 33.66 to 61.52
|
60.945 Picogram per milliliter
Interval 56.43 to 65.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 8: Pre-dose, n=8,5,8,3,1
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.25
|
4.590 Picogram per milliliter
Interval 3.52 to 10.05
|
4.160 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 8: 10 minutes, n=9,5,8,3,1
|
4.300 Picogram per milliliter
Interval 0.0 to 10.2
|
6.160 Picogram per milliliter
Interval 5.01 to 8.89
|
30.850 Picogram per milliliter
Interval 2.28 to 60.54
|
71.910 Picogram per milliliter
Interval 55.71 to 74.13
|
89.510 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 57: 4 hours, n=4,3,6,1,0
|
3.855 Picogram per milliliter
Interval 0.0 to 6.13
|
3.530 Picogram per milliliter
Interval 3.36 to 16.3
|
13.735 Picogram per milliliter
Interval 2.45 to 34.34
|
55.980 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 246: 10 minutes, n=1,0,0,0,0
|
37.200 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Part 1a: Plasma Concentration of GSK1795091
Day 414: 10 minutes, n=1,0,0,0,0
|
18.600 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: Pre-dose, n=6,5,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 15: 10 minutes, n=4,4,0,0,0
|
16.000 Picogram per milliliter
Interval 3.62 to 19.05
|
27.645 Picogram per milliliter
Interval 25.7 to 49.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 15: 24 hours, n=5,2,0,0,0
|
6.890 Picogram per milliliter
Interval 0.0 to 12.48
|
14.735 Picogram per milliliter
Interval 10.87 to 18.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 57: 24 hours, n=3,2,0,0,0
|
8.250 Picogram per milliliter
Interval 6.59 to 11.44
|
17.530 Picogram per milliliter
Interval 16.44 to 18.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: 10 minutes, n=6,5,0,0,0
|
12.870 Picogram per milliliter
Interval 0.0 to 15.8
|
32.300 Picogram per milliliter
Interval 27.1 to 40.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: 2 hours, n=6,5,0,0,0
|
14.100 Picogram per milliliter
Interval 0.0 to 28.8
|
29.770 Picogram per milliliter
Interval 25.6 to 37.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: 4 hours, n=6,5,0,0,0
|
13.000 Picogram per milliliter
Interval 0.0 to 14.4
|
25.330 Picogram per milliliter
Interval 23.3 to 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: 6 hours, n=6,4,0,0,0
|
12.065 Picogram per milliliter
Interval 0.0 to 13.4
|
23.690 Picogram per milliliter
Interval 21.1 to 30.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 1: 24 hours, n=6,4,0,0,0
|
7.680 Picogram per milliliter
Interval 0.0 to 9.17
|
19.650 Picogram per milliliter
Interval 17.88 to 22.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1b: Plasma Concentration of GSK1795091
Day 8: Pre-dose, n=5,4,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
2.215 Picogram per milliliter
Interval 0.0 to 2.74
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1b: Plasma Concentration of GSK1795091
Day 8: 10 minutes, n=5,4,0,0,0
|
15.280 Picogram per milliliter
Interval 2.97 to 17.28
|
29.550 Picogram per milliliter
Interval 29.3 to 35.64
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1b: Plasma Concentration of GSK1795091
Day 8: 4 hours, n=5,4,0,0,0
|
11.460 Picogram per milliliter
Interval 0.0 to 15.94
|
23.850 Picogram per milliliter
Interval 18.97 to 30.49
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 15: Pre-dose, n=4,3,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 4.44
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
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Part 1b: Plasma Concentration of GSK1795091
Day 15: 4 hours, n=4,4,0,0,0
|
10.145 Picogram per milliliter
Interval 2.7 to 15.2
|
24.100 Picogram per milliliter
Interval 17.82 to 34.97
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 22: Pre-dose, n=5,2,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 2.45
|
1.015 Picogram per milliliter
Interval 0.0 to 2.03
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 57: Pre-dose, n=3,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.33
|
2.300 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 57: 10 minutes, n=3,2,0,0,0
|
14.620 Picogram per milliliter
Interval 12.2 to 17.86
|
28.155 Picogram per milliliter
Interval 25.98 to 30.33
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 57: 4 hours, n=1,1,0,0,0
|
12.140 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
25.510 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1b: Plasma Concentration of GSK1795091
Day 64: Pre-dose, n=1,2,0,0,0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
1.875 Picogram per milliliter
Interval 0.0 to 3.75
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1b: Plasma Concentration of GSK1795091
Day 64: 10 minutes, n=2,2,0,0,0
|
6.910 Picogram per milliliter
Interval 0.0 to 13.82
|
34.345 Picogram per milliliter
Interval 32.14 to 36.55
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1b: Plasma Concentration of GSK1795091
Day 78: 10 minutes, n=2,2,0,0,0
|
6.980 Picogram per milliliter
Interval 2.48 to 11.48
|
34.875 Picogram per milliliter
Interval 32.02 to 37.73
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=7 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1c: Plasma Concentration of GSK1795091
Day 22: Pre-dose, n=4,3,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.49
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1c: Plasma Concentration of GSK1795091
Day 1: Pre-dose, n=7,6,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 1: 10 minutes, n=7,6,0,0,0
|
13.600 Picogram per milliliter
Interval 0.0 to 14.0
|
27.965 Picogram per milliliter
Interval 13.2 to 38.64
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 1: 2 hours, n=6,6,0,0,0
|
11.475 Picogram per milliliter
Interval 0.0 to 12.77
|
28.775 Picogram per milliliter
Interval 10.5 to 56.63
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1c: Plasma Concentration of GSK1795091
Day 1: 4 hours, n=7,6,0,0,0
|
9.890 Picogram per milliliter
Interval 0.0 to 12.2
|
25.970 Picogram per milliliter
Interval 10.1 to 32.63
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1c: Plasma Concentration of GSK1795091
Day 1: 6 hours, n=7,6,0,0,0
|
9.460 Picogram per milliliter
Interval 0.0 to 12.54
|
24.415 Picogram per milliliter
Interval 8.83 to 33.69
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 1c: Plasma Concentration of GSK1795091
Day 1: 24 hours, n=7,6,0,0,0
|
8.370 Picogram per milliliter
Interval 0.0 to 10.14
|
15.825 Picogram per milliliter
Interval 6.31 to 24.03
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 8: Pre-dose, n=6,5,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
2.060 Picogram per milliliter
Interval 0.0 to 2.51
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 8: 10 minutes, n=7,5,0,0,0
|
12.810 Picogram per milliliter
Interval 0.0 to 16.0
|
24.260 Picogram per milliliter
Interval 14.8 to 35.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 8: 4 hours, n=6,5,0,0,0
|
9.420 Picogram per milliliter
Interval 2.56 to 13.68
|
23.390 Picogram per milliliter
Interval 12.3 to 27.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 15: Pre-dose, n=3,4,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.26
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 15: 10 minutes, n=7,6,0,0,0
|
9.200 Picogram per milliliter
Interval 0.0 to 14.7
|
28.015 Picogram per milliliter
Interval 12.6 to 54.93
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 15: 4 hours, n=7,4,0,0,0
|
7.070 Picogram per milliliter
Interval 0.0 to 11.6
|
17.825 Picogram per milliliter
Interval 6.81 to 26.6
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 15: 24 hours, n=7,5,0,0,0
|
4.580 Picogram per milliliter
Interval 0.0 to 8.42
|
11.230 Picogram per milliliter
Interval 5.53 to 19.8
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1c: Plasma Concentration of GSK1795091
Day 57: Pre-dose, n=2,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
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—
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—
|
—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 57: 10 minutes, n=2,1,0,0,0
|
14.665 Picogram per milliliter
Interval 12.8 to 16.53
|
23.840 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 57: 4 hours, n=2,0,0,0,0
|
10.515 Picogram per milliliter
Interval 10.13 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 57: 24 hours, n=2,2,0,0,0
|
7.460 Picogram per milliliter
Interval 6.72 to 8.2
|
9.780 Picogram per milliliter
Interval 4.87 to 14.69
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 64: Pre-dose, n=2,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 64: 10 minutes, n=3,1,0,0,0
|
13.570 Picogram per milliliter
Interval 11.5 to 14.0
|
31.680 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
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—
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—
|
|
Part 1c: Plasma Concentration of GSK1795091
Day 78: 10 minutes, n=2,0,0,0,0
|
15.455 Picogram per milliliter
Interval 14.71 to 16.2
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
|
—
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—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 1, n=7,5,9,4,2
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4.180 Picogram per milliliter
Interval 3.16 to 5.8
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4.920 Picogram per milliliter
Interval 4.0 to 11.9
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29.20 Picogram per milliliter
Interval 5.59 to 53.4
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59.95 Picogram per milliliter
Interval 43.6 to 68.1
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82.18 Picogram per milliliter
Interval 65.0 to 99.4
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 8, n=8,5,8,3,1
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4.720 Picogram per milliliter
Interval 2.49 to 10.2
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6.160 Picogram per milliliter
Interval 5.01 to 8.89
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30.85 Picogram per milliliter
Interval 2.28 to 60.5
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71.91 Picogram per milliliter
Interval 55.7 to 74.1
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89.51 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 15, n=9,4,8,3,0
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5.110 Picogram per milliliter
Interval 2.47 to 14.5
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5.120 Picogram per milliliter
Interval 4.35 to 8.96
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35.63 Picogram per milliliter
Interval 7.96 to 53.4
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57.57 Picogram per milliliter
Interval 46.5 to 76.8
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 57, n=4,3,4,1,0
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6.400 Picogram per milliliter
Interval 3.03 to 8.94
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7.470 Picogram per milliliter
Interval 6.08 to 18.2
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32.60 Picogram per milliliter
Interval 6.87 to 41.3
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60.09 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 64, n=5,4,3,2,0
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3.340 Picogram per milliliter
Interval 0.0 to 4.18
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7.055 Picogram per milliliter
Interval 4.95 to 20.6
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26.70 Picogram per milliliter
Interval 12.0 to 42.1
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75.05 Picogram per milliliter
Interval 74.4 to 75.7
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 78, n=5,3,4,2,0
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3.980 Picogram per milliliter
Interval 2.1 to 10.5
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10.10 Picogram per milliliter
Interval 6.8 to 24.8
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22.70 Picogram per milliliter
Interval 5.48 to 45.2
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72.22 Picogram per milliliter
Interval 67.8 to 76.6
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 162, n=1,0,0,0,0
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3.450 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 246, n=1,0,0,0,0
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37.20 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 414, n=1,0,0,0,0
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18.60 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Day 498, n=1,0,0,0,0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1b: Cmax of GSK1795091
Day 1, n=6,5,0,0,0
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14.95 Picogram per milliliter
Interval 2.23 to 28.8
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32.30 Picogram per milliliter
Interval 27.1 to 40.1
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Part 1b: Cmax of GSK1795091
Day 8, n=5,4,0,0,0
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15.28 Picogram per milliliter
Interval 2.97 to 17.3
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29.55 Picogram per milliliter
Interval 29.3 to 35.6
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Part 1b: Cmax of GSK1795091
Day 15, n=4,4,0,0,0
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16.00 Picogram per milliliter
Interval 3.62 to 19.1
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27.80 Picogram per milliliter
Interval 25.7 to 49.0
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Part 1b: Cmax of GSK1795091
Day 57, n=3,2,0,0,0
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14.62 Picogram per milliliter
Interval 13.2 to 17.9
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28.16 Picogram per milliliter
Interval 26.0 to 30.3
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Part 1b: Cmax of GSK1795091
Day 64, n=2,2,0,0,0
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6.910 Picogram per milliliter
Interval 0.0 to 13.8
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34.35 Picogram per milliliter
Interval 32.1 to 36.6
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Part 1b: Cmax of GSK1795091
Day 78, n=2,2,0,0,0
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6.980 Picogram per milliliter
Interval 2.48 to 11.5
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34.88 Picogram per milliliter
Interval 32.0 to 37.7
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SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
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Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
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Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1c: Cmax of GSK1795091
Day 78, n=2,0,0,0,0
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15.46 Picogram per milliliter
Interval 14.7 to 16.2
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Part 1c: Cmax of GSK1795091
Day 1, n=6,6,0,0,0
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13.75 Picogram per milliliter
Interval 6.04 to 14.0
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30.56 Picogram per milliliter
Interval 13.2 to 56.6
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Part 1c: Cmax of GSK1795091
Day 8, n=6,5,0,0,0
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13.53 Picogram per milliliter
Interval 5.44 to 16.0
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25.35 Picogram per milliliter
Interval 14.8 to 35.3
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Part 1c: Cmax of GSK1795091
Day 15, n=6,6,0,0,0
|
10.19 Picogram per milliliter
Interval 4.6 to 14.7
|
28.02 Picogram per milliliter
Interval 12.6 to 54.9
|
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—
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—
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—
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Part 1c: Cmax of GSK1795091
Day 57, n=2,1,0,0,0
|
14.67 Picogram per milliliter
Interval 12.8 to 16.5
|
23.84 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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Part 1c: Cmax of GSK1795091
Day 64, n=3,1,0,0,0
|
13.57 Picogram per milliliter
Interval 11.5 to 14.0
|
31.68 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.
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SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=8 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=3 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=1 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091
Day 1, n=5,5,8,3,1
|
48.08 Hours*picogram per milliliter
Interval 35.0 to 276.0
|
227.6 Hours*picogram per milliliter
Interval 39.0 to 383.0
|
1804 Hours*picogram per milliliter
Interval 41.0 to 2540.0
|
3615 Hours*picogram per milliliter
Interval 2390.0 to 4300.0
|
4166 Hours*picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual AUC(0-tau) for this single participant.
|
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Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091
Day 15, n=2,2,6,3,0
|
256.7 Hours*picogram per milliliter
Interval 191.0 to 322.0
|
318.3 Hours*picogram per milliliter
Interval 294.0 to 343.0
|
1907 Hours*picogram per milliliter
Interval 273.0 to 3000.0
|
3479 Hours*picogram per milliliter
Interval 3020.0 to 4900.0
|
—
|
—
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—
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—
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—
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—
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—
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—
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|
Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091
Day 57, n=0,3,2,1,0
|
—
|
267.9 Hours*picogram per milliliter
Interval 247.0 to 1140.0
|
2027 Hours*picogram per milliliter
Interval 1410.0 to 2640.0
|
3515 Hours*picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual AUC(0-tau) for this single participant.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1b: AUC(0-tau) GSK1795091
Day 1, n=4,4,0,0,0
|
819.1 Hours*picogram per milliliter
Interval 721.0 to 899.0
|
1840 Hours*picogram per milliliter
Interval 1560.0 to 2120.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1b: AUC(0-tau) GSK1795091
Day 15, n=3,2,0,0,0
|
661.9 Hours*picogram per milliliter
Interval 632.0 to 916.0
|
1453 Hours*picogram per milliliter
Interval 1100.0 to 1800.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1b: AUC(0-tau) GSK1795091
Day 57, n=1,2,0,0,0
|
845.2 Hours*picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual AUC(0-tau) for this single participant.
|
1757 Hours*picogram per milliliter
Interval 1740.0 to 1780.0
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1c: AUC(0-tau) GSK1795091
Day 1, n=4,5,0,0,0
|
851.7 Hours*picogram per milliliter
Interval 208.0 to 990.0
|
1611 Hours*picogram per milliliter
Interval 645.0 to 1710.0
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
|
Part 1c: AUC(0-tau) GSK1795091
Day 15, n=3,2,0,0,0
|
566.9 Hours*picogram per milliliter
Interval 460.0 to 815.0
|
1189 Hours*picogram per milliliter
Interval 540.0 to 1840.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Part 1c: AUC(0-tau) GSK1795091
Day 57, n=2,1,0,0,0
|
778.0 Hours*picogram per milliliter
Interval 750.0 to 805.0
|
1640 Hours*picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual AUC(0-tau) for this single participant.
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 57, 64, 78, 162, 246, 414 and 498: Pre-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=8 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=3 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=1 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1a: Predose Concentration (Cpre) of GSK1795091
Day 8, n=8,5,8,3,1
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.25
|
4.590 Picogram per milliliter
Interval 3.52 to 10.1
|
4.160 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Predose Concentration (Cpre) of GSK1795091
Day 15, n=9,3,8,2,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.99
|
4.975 Picogram per milliliter
Interval 4.73 to 5.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Predose Concentration (Cpre) of GSK1795091
Day 22, n=9,3,7,3,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 5.6
|
4.450 Picogram per milliliter
Interval 4.21 to 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Predose Concentration (Cpre) of GSK1795091
Day 57, n=4,3,4,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
1.215 Picogram per milliliter
Interval 0.0 to 6.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1a: Predose Concentration (Cpre) of GSK1795091
Day 64, n=4,4,4,1,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
3.040 Picogram per milliliter
Interval 0.0 to 46.2
|
15.30 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1b: Cpre of GSK1795091
Day 64, n=1,2,0,0,0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
1.875 Picogram per milliliter
Interval 0.0 to 3.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Cpre of GSK1795091
Day 8, n=5,4,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
2.215 Picogram per milliliter
Interval 0.0 to 2.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Cpre of GSK1795091
Day 15, n=4,3,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 4.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Cpre of GSK1795091
Day 22, n=5,2,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 2.45
|
1.015 Picogram per milliliter
Interval 0.0 to 2.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1b: Cpre of GSK1795091
Day 57, n=3,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.33
|
2.300 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dosePopulation: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1c: Cpre of GSK1795091
Day 8, n=5,5,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
2.060 Picogram per milliliter
Interval 0.0 to 2.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1c: Cpre of GSK1795091
Day 64, n=2,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1c: Cpre of GSK1795091
Day 15, n=3,4,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1c: Cpre of GSK1795091
Day 22, n=3,3,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Interval 0.0 to 3.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1c: Cpre of GSK1795091
Day 57, n=2,1,0,0,0
|
0.000 Picogram per milliliter
Interval 0.0 to 0.0
|
0.000 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=1 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=3 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1b: Number of Participants With the Present ADA Against GSK3359609
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Samples were collected but will not be analyzed for the presence of anti-pembrolizumab antibodies as pembrolizumab immunogenicity has been previously characterized.
Serum samples were collected at indicated time points for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were planned to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=7 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1c: Number of Participants With the Present ADA Against Pembrolizumab
|
NA Participants
Samples were collected but will not be analyzed for the presence of anti-pembrolizumab antibodies as pembrolizumab immunogenicity has been previously characterized.
|
NA Participants
Samples were collected but will not be analyzed for the presence of anti-pembrolizumab antibodies as pembrolizumab immunogenicity has been previously characterized.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
An adverse event 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. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study
STEAEs
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study
TEAEs
|
9 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 47 months and 13 daysPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
An adverse event 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. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho) (Low), hemoglobin (Hb) (Low) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0
|
7 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0
|
6 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), hemoglobin (Hb) and platelet count (PC).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
Blood samples were collected for the analysis of following chemistry parameters: albumin (Hypo), ALP, ALT, AST, bilirubin, calcium (Hyper and Hypo), creatinine, glucose (Hyper and Hypo), potassium (Hyper and Hypo) and sodium (Hyper and Hypo). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Outcome measures
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 Participants
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 Participants
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 Participants
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 Participants
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 Participants
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
7 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Blood samples were planned to be collected for the analysis of following chemistry parameters: albumin, ALP, ALT, AST, bilirubin, calcium, creatinine, glucose, potassium and sodium.
Outcome measures
Outcome data not reported
Adverse Events
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
Serious events: 1 serious events
Other events: 9 other events
Deaths: 6 deaths
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 participants at risk
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 participants at risk
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 participants at risk
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 participants at risk
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 participants at risk
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 participants at risk
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Chills
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Hypothermia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
Other adverse events
| Measure |
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
n=9 participants at risk
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
n=6 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
n=9 participants at risk
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
n=4 participants at risk
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
n=2 participants at risk
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
|
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
n=6 participants at risk
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
n=5 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
|
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
n=7 participants at risk
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
n=6 participants at risk
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
3/9 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Eye disorders
Dry eye
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 11 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
42.9%
3/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Gastrointestinal disorders
Vomiting
|
55.6%
5/9 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
28.6%
2/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Asthenia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Chills
|
55.6%
5/9 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
100.0%
6/6 • Number of events 20 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Early satiety
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Fatigue
|
66.7%
6/9 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
66.7%
6/9 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Injection site reaction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Malaise
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Nodule
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Oedema
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Hepatobiliary disorders
Cholelithiasis
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Immune system disorders
Cytokine release syndrome
|
11.1%
1/9 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Pneumonia
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
2/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood potassium increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Blood uric acid increased
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Heart rate increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Weight decreased
|
44.4%
4/9 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
White blood cell count increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
2/9 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
22.2%
2/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
3/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Restless legs syndrome
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Testicular microlithiasis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Vaginal reflux
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 47 months and 13 days in Part 1
All Treated Population. Data is presented for Part 1a of all arms, Part 1b and Part 1c (GSK1795091 50ng and 100mg arms only) as data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to a manufacturing issue.
|
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