Trial Outcomes & Findings for A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors (NCT NCT03843359)
NCT ID: NCT03843359
Last Updated: 2026-01-08
Results Overview
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
97 participants
Primary outcome timeframe
Up to 21 Days
Results posted on
2026-01-08
Participant Flow
This study consisted of 2 phases - Dose Escalation (Part 1A and Part 2A) and Dose Expansion (Part 1B and Part 2B). As pre-specified in protocol, dose expansion phases were not conducted following sponsor's decision to cease further enrolment into the study.
The results presented are based on the data cut-off date of 05 Apr 2024. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continued Treatment (PACT) phase and their data will be reported after they stop receiving treatment as per protocol.
Participant milestones
| Measure |
Part 1A: GSK3745417 0.1 mg (Q3W)
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q1W)
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
|
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
|
Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
|
Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.
|
Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Escalation Phase
STARTED
|
3
|
6
|
14
|
2
|
19
|
10
|
9
|
4
|
12
|
4
|
3
|
10
|
1
|
0
|
0
|
0
|
|
Escalation Phase
All Treated Population
|
3
|
6
|
14
|
2
|
19
|
10
|
9
|
4
|
12
|
4
|
3
|
10
|
1
|
0
|
0
|
0
|
|
Escalation Phase
Dose-Limiting Toxicities (DLT)Evaluable Population
|
3
|
4
|
4
|
2
|
9
|
9
|
0
|
4
|
9
|
4
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Escalation Phase
Pharmacokinetic (PK) Population
|
3
|
6
|
14
|
2
|
19
|
10
|
9
|
4
|
12
|
4
|
3
|
10
|
1
|
0
|
0
|
0
|
|
Escalation Phase
COMPLETED
|
3
|
5
|
6
|
1
|
15
|
9
|
8
|
4
|
8
|
4
|
3
|
9
|
0
|
0
|
0
|
0
|
|
Escalation Phase
NOT COMPLETED
|
0
|
1
|
8
|
1
|
4
|
1
|
1
|
0
|
4
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Crossover
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
5
|
|
Crossover
All Treated Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
5
|
|
Crossover
Pharmacokinetic (PK) Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
5
|
|
Crossover
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Part 1A: GSK3745417 0.1 mg (Q3W)
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q1W)
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
|
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
|
Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
|
Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.
|
Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Crossover
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Escalation Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Escalation Phase
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Escalation Phase
Investigator site closed
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Escalation Phase
Ongoing at the time of analysis
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Escalation Phase
Participants were crossed over OR were re-treated following progression
|
0
|
0
|
7
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Crossover
Investigator site closed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Crossover
Ongoing at the time of analysis
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=6 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q1W)
n=14 Participants
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
n=2 Participants
Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=19 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
n=9 Participants
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
n=4 Participants
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
n=12 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=4 Participants
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=3 Participants
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
|
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=10 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=1 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.0 YEARS
STANDARD_DEVIATION 1.73 • n=18 Participants
|
46.8 YEARS
STANDARD_DEVIATION 17.81 • n=17 Participants
|
55.8 YEARS
STANDARD_DEVIATION 11.44 • n=35 Participants
|
66.0 YEARS
STANDARD_DEVIATION 2.83 • n=42 Participants
|
56.5 YEARS
STANDARD_DEVIATION 15.13 • n=217 Participants
|
53.3 YEARS
STANDARD_DEVIATION 11.41 • n=1518 Participants
|
51.3 YEARS
STANDARD_DEVIATION 9.08 • n=5 Participants
|
66.3 YEARS
STANDARD_DEVIATION 5.80 • n=4 Participants
|
55.5 YEARS
STANDARD_DEVIATION 12.21 • n=48 Participants
|
54.5 YEARS
STANDARD_DEVIATION 7.14 • n=10 Participants
|
61.7 YEARS
STANDARD_DEVIATION 12.50 • n=119 Participants
|
58.0 YEARS
STANDARD_DEVIATION 10.45 • n=301 Participants
|
NA YEARS
STANDARD_DEVIATION NA • n=6 Participants
|
55.5 YEARS
STANDARD_DEVIATION 12.11 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=217 Participants
|
7 Participants
n=1518 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=48 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
5 Participants
n=301 Participants
|
1 Participants
n=6 Participants
|
50 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=35 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=217 Participants
|
3 Participants
n=1518 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=48 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=119 Participants
|
5 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
47 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
14 Participants
n=35 Participants
|
2 Participants
n=42 Participants
|
19 Participants
n=217 Participants
|
10 Participants
n=1518 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=48 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=119 Participants
|
10 Participants
n=301 Participants
|
1 Participants
n=6 Participants
|
97 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
1 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
1 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
13 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
19 Participants
n=217 Participants
|
10 Participants
n=1518 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=48 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
8 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
84 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=1518 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=301 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 21 DaysPopulation: DLT Evaluable population included All Treated population who completed at least 21 days of DLT period or discontinued from treatment within 21 days due to an AE meeting the definition of a DLT.
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=9 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=9 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=2 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 29 DaysPopulation: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 29 DaysPopulation: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 29 DaysPopulation: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=9 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 62 weeksPopulation: All treated population included all participants who received at least one dose of GSK3745417. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for AE (NCI-CTCAE) (version 5.0):G1=Mild,G2=Moderate,G3=Severe or medically significant but not immediately life-threatening,G4=Life-threatening consequences,G5=Death related AE.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=14 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=2 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=6 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=19 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
n=9 Participants
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 2
|
6 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 1
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 3
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 93 weeksPopulation: All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=4 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=3 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=12 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=1 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 3
|
4 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 30.3 weeksPopulation: All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=5 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 1
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 2
|
3 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 3
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
TEAEs, Grade 5
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 1
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 2
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 3
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
STEAEs, Grade 5
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom at least one PK sample was obtained and analyzed. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=19 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=14 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=2 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=9 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+8HR
|
0.338 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 19.6
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 37.96
|
0.195 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 4.62
|
17.930 Nanogram/ millilitre (ng/mL)
Interval 4.56 to 31.3
|
2.200 Nanogram/ millilitre (ng/mL)
Interval 0.286 to 49.586
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+24HR
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 6.79
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.488
|
3.460 Nanogram/ millilitre (ng/mL)
Interval 0.939 to 5.98
|
0.700 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 6.781
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 1.69
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.02
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.209
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+5MIN
|
49.810 Nanogram/ millilitre (ng/mL)
Interval 7.71 to 80.8
|
119.990 Nanogram/ millilitre (ng/mL)
Interval 69.42 to 162.65
|
23.550 Nanogram/ millilitre (ng/mL)
Interval 14.6 to 42.09
|
21.350 Nanogram/ millilitre (ng/mL)
Interval 13.3 to 29.4
|
111.450 Nanogram/ millilitre (ng/mL)
Interval 71.438 to 153.211
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+15MIN
|
45.700 Nanogram/ millilitre (ng/mL)
Interval 30.21 to 73.21
|
99.730 Nanogram/ millilitre (ng/mL)
Interval 58.35 to 137.59
|
21.110 Nanogram/ millilitre (ng/mL)
Interval 19.34 to 38.18
|
—
|
94.602 Nanogram/ millilitre (ng/mL)
Interval 67.624 to 136.044
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+30MIN
|
36.370 Nanogram/ millilitre (ng/mL)
Interval 23.51 to 69.48
|
92.780 Nanogram/ millilitre (ng/mL)
Interval 47.53 to 135.67
|
16.790 Nanogram/ millilitre (ng/mL)
Interval 16.56 to 37.0
|
—
|
80.173 Nanogram/ millilitre (ng/mL)
Interval 38.867 to 130.765
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+45MIN
|
31.750 Nanogram/ millilitre (ng/mL)
Interval 21.09 to 67.68
|
79.810 Nanogram/ millilitre (ng/mL)
Interval 37.51 to 136.94
|
15.735 Nanogram/ millilitre (ng/mL)
Interval 13.11 to 32.44
|
—
|
75.977 Nanogram/ millilitre (ng/mL)
Interval 31.154 to 114.318
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+1HR
|
31.230 Nanogram/ millilitre (ng/mL)
Interval 19.79 to 63.71
|
73.750 Nanogram/ millilitre (ng/mL)
Interval 23.8 to 135.51
|
14.545 Nanogram/ millilitre (ng/mL)
Interval 10.54 to 30.16
|
—
|
74.026 Nanogram/ millilitre (ng/mL)
Interval 22.289 to 111.132
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+2HR
|
15.695 Nanogram/ millilitre (ng/mL)
Interval 4.39 to 45.83
|
45.560 Nanogram/ millilitre (ng/mL)
Interval 12.84 to 104.09
|
7.880 Nanogram/ millilitre (ng/mL)
Interval 4.62 to 23.28
|
13.400 Nanogram/ millilitre (ng/mL)
Interval 13.3 to 13.5
|
50.148 Nanogram/ millilitre (ng/mL)
Interval 5.842 to 97.944
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+4HR
|
8.150 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 31.7
|
17.490 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 86.11
|
2.490 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 14.26
|
7.320 Nanogram/ millilitre (ng/mL)
Interval 6.73 to 7.91
|
20.212 Nanogram/ millilitre (ng/mL)
Interval 1.238 to 79.302
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+8HR
|
0.438 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 23.9
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 60.67
|
0.381 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 5.67
|
2.840 Nanogram/ millilitre (ng/mL)
Interval 2.66 to 3.02
|
7.987 Nanogram/ millilitre (ng/mL)
Interval 0.393 to 38.692
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK2, EOI+24HR
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 11.4
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 21.74
|
0.067 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 4.58
|
0.516 Nanogram/ millilitre (ng/mL)
Interval 0.465 to 0.566
|
1.129 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 7.613
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 2.24
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 2.08
|
0.665 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 1.33
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.135
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+5MIN
|
49.010 Nanogram/ millilitre (ng/mL)
Interval 24.0 to 94.44
|
101.655 Nanogram/ millilitre (ng/mL)
Interval 64.49 to 131.3
|
24.245 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 43.9
|
9.390 Nanogram/ millilitre (ng/mL)
Interval 2.28 to 16.5
|
121.546 Nanogram/ millilitre (ng/mL)
Interval 70.878 to 139.062
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+15MIN
|
44.120 Nanogram/ millilitre (ng/mL)
Interval 36.05 to 75.68
|
97.570 Nanogram/ millilitre (ng/mL)
Interval 58.29 to 120.93
|
27.620 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 42.04
|
—
|
104.424 Nanogram/ millilitre (ng/mL)
Interval 57.08 to 117.498
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+30MIN
|
36.790 Nanogram/ millilitre (ng/mL)
Interval 29.72 to 60.53
|
90.085 Nanogram/ millilitre (ng/mL)
Interval 48.58 to 114.0
|
25.495 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 36.62
|
—
|
85.103 Nanogram/ millilitre (ng/mL)
Interval 44.011 to 118.11
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+45MIN
|
34.510 Nanogram/ millilitre (ng/mL)
Interval 24.97 to 55.42
|
76.765 Nanogram/ millilitre (ng/mL)
Interval 42.74 to 110.03
|
23.095 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 37.0
|
—
|
69.923 Nanogram/ millilitre (ng/mL)
Interval 29.713 to 100.74
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+1HR
|
32.030 Nanogram/ millilitre (ng/mL)
Interval 21.59 to 61.02
|
63.890 Nanogram/ millilitre (ng/mL)
Interval 28.69 to 101.89
|
21.055 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 30.99
|
—
|
56.589 Nanogram/ millilitre (ng/mL)
Interval 21.538 to 93.551
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+2HR
|
17.600 Nanogram/ millilitre (ng/mL)
Interval 5.52 to 38.78
|
41.550 Nanogram/ millilitre (ng/mL)
Interval 14.87 to 72.56
|
10.020 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 24.84
|
8.460 Nanogram/ millilitre (ng/mL)
Interval 0.319 to 16.6
|
32.906 Nanogram/ millilitre (ng/mL)
Interval 6.756 to 66.786
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+4HR
|
8.480 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 33.8
|
14.945 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 57.79
|
2.970 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 13.98
|
5.072 Nanogram/ millilitre (ng/mL)
Interval 0.244 to 9.9
|
14.279 Nanogram/ millilitre (ng/mL)
Interval 1.563 to 32.725
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+8HR
|
0.236 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 20.5
|
2.845 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 32.45
|
0.462 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 8.93
|
5.480 Nanogram/ millilitre (ng/mL)
Interval 5.48 to 5.48
|
1.944 Nanogram/ millilitre (ng/mL)
Interval 0.344 to 8.853
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK3, EOI+24HR
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 10.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 11.61
|
0.054 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 2.24
|
1.020 Nanogram/ millilitre (ng/mL)
Interval 1.02 to 1.02
|
0.459 Nanogram/ millilitre (ng/mL)
Interval 0.111 to 2.797
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 2.99
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.508
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+5MIN
|
49.095 Nanogram/ millilitre (ng/mL)
Interval 9.84 to 99.63
|
106.260 Nanogram/ millilitre (ng/mL)
Interval 77.2 to 157.53
|
22.730 Nanogram/ millilitre (ng/mL)
Interval 3.24 to 40.28
|
27.850 Nanogram/ millilitre (ng/mL)
Interval 23.1 to 32.6
|
112.175 Nanogram/ millilitre (ng/mL)
Interval 80.304 to 156.837
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+15MIN
|
41.540 Nanogram/ millilitre (ng/mL)
Interval 12.42 to 75.62
|
99.440 Nanogram/ millilitre (ng/mL)
Interval 57.18 to 131.18
|
20.300 Nanogram/ millilitre (ng/mL)
Interval 4.95 to 35.77
|
—
|
102.480 Nanogram/ millilitre (ng/mL)
Interval 64.598 to 139.072
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+30MIN
|
33.500 Nanogram/ millilitre (ng/mL)
Interval 11.1 to 68.82
|
92.590 Nanogram/ millilitre (ng/mL)
Interval 49.6 to 123.28
|
16.800 Nanogram/ millilitre (ng/mL)
Interval 3.87 to 33.54
|
—
|
90.573 Nanogram/ millilitre (ng/mL)
Interval 42.598 to 123.215
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+45MIN
|
31.300 Nanogram/ millilitre (ng/mL)
Interval 9.5 to 61.46
|
85.550 Nanogram/ millilitre (ng/mL)
Interval 38.82 to 120.77
|
13.380 Nanogram/ millilitre (ng/mL)
Interval 3.33 to 28.27
|
—
|
68.947 Nanogram/ millilitre (ng/mL)
Interval 34.245 to 112.398
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+1HR
|
28.030 Nanogram/ millilitre (ng/mL)
Interval 13.9 to 54.72
|
66.970 Nanogram/ millilitre (ng/mL)
Interval 28.64 to 115.46
|
11.400 Nanogram/ millilitre (ng/mL)
Interval 1.02 to 27.59
|
—
|
64.737 Nanogram/ millilitre (ng/mL)
Interval 23.292 to 119.65
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+2HR
|
17.320 Nanogram/ millilitre (ng/mL)
Interval 5.79 to 52.02
|
31.510 Nanogram/ millilitre (ng/mL)
Interval 10.4 to 107.26
|
6.990 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 19.26
|
14.000 Nanogram/ millilitre (ng/mL)
Interval 11.7 to 16.3
|
38.423 Nanogram/ millilitre (ng/mL)
Interval 5.331 to 68.771
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+4HR
|
7.620 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 34.6
|
10.710 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 95.57
|
1.850 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 14.24
|
8.605 Nanogram/ millilitre (ng/mL)
Interval 6.71 to 10.5
|
13.288 Nanogram/ millilitre (ng/mL)
Interval 1.373 to 37.803
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+8HR
|
0.129 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 25.9
|
8.370 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 57.02
|
0.391 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 5.27
|
4.020 Nanogram/ millilitre (ng/mL)
Interval 4.02 to 4.02
|
2.564 Nanogram/ millilitre (ng/mL)
Interval 0.362 to 9.556
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK4, EOI+24HR
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 12.7
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 19.21
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 1.07
|
0.791 Nanogram/ millilitre (ng/mL)
Interval 0.791 to 0.791
|
0.686 Nanogram/ millilitre (ng/mL)
Interval 0.114 to 3.722
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 2.97
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.195
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.137
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+5MIN
|
47.173 Nanogram/ millilitre (ng/mL)
Interval 26.8 to 87.17
|
113.140 Nanogram/ millilitre (ng/mL)
Interval 66.48 to 162.7
|
19.480 Nanogram/ millilitre (ng/mL)
Interval 7.72 to 27.6
|
21.350 Nanogram/ millilitre (ng/mL)
Interval 16.0 to 26.7
|
112.617 Nanogram/ millilitre (ng/mL)
Interval 85.635 to 137.264
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+15MIN
|
42.492 Nanogram/ millilitre (ng/mL)
Interval 38.48 to 78.4
|
106.120 Nanogram/ millilitre (ng/mL)
Interval 57.19 to 150.86
|
17.260 Nanogram/ millilitre (ng/mL)
Interval 15.4 to 18.55
|
—
|
94.482 Nanogram/ millilitre (ng/mL)
Interval 72.447 to 129.269
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+30MIN
|
33.345 Nanogram/ millilitre (ng/mL)
Interval 29.64 to 73.61
|
85.740 Nanogram/ millilitre (ng/mL)
Interval 43.4 to 137.52
|
15.290 Nanogram/ millilitre (ng/mL)
Interval 12.65 to 19.12
|
—
|
76.850 Nanogram/ millilitre (ng/mL)
Interval 51.081 to 112.129
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+45MIN
|
27.900 Nanogram/ millilitre (ng/mL)
Interval 23.75 to 72.77
|
92.490 Nanogram/ millilitre (ng/mL)
Interval 36.76 to 106.33
|
14.090 Nanogram/ millilitre (ng/mL)
Interval 10.1 to 15.94
|
—
|
70.156 Nanogram/ millilitre (ng/mL)
Interval 46.092 to 105.535
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+1HR
|
25.885 Nanogram/ millilitre (ng/mL)
Interval 22.437 to 60.58
|
69.760 Nanogram/ millilitre (ng/mL)
Interval 34.67 to 102.53
|
12.510 Nanogram/ millilitre (ng/mL)
Interval 8.94 to 14.18
|
—
|
69.849 Nanogram/ millilitre (ng/mL)
Interval 29.221 to 100.886
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+2HR
|
14.350 Nanogram/ millilitre (ng/mL)
Interval 6.29 to 41.8
|
47.890 Nanogram/ millilitre (ng/mL)
Interval 15.2 to 84.87
|
7.370 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 12.5
|
14.000 Nanogram/ millilitre (ng/mL)
Interval 11.3 to 16.7
|
49.617 Nanogram/ millilitre (ng/mL)
Interval 9.674 to 78.627
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+4HR
|
5.495 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 34.5
|
23.080 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 51.94
|
1.620 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 7.76
|
8.010 Nanogram/ millilitre (ng/mL)
Interval 6.2 to 9.82
|
22.082 Nanogram/ millilitre (ng/mL)
Interval 2.296 to 52.873
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+8HR
|
0.746 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 25.9
|
6.120 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 39.08
|
0.397 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 4.2
|
3.470 Nanogram/ millilitre (ng/mL)
Interval 3.47 to 3.47
|
2.599 Nanogram/ millilitre (ng/mL)
Interval 0.492 to 21.474
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK5, EOI+24HR
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 12.2
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 16.49
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.92
|
0.856 Nanogram/ millilitre (ng/mL)
Interval 0.856 to 0.856
|
0.752 Nanogram/ millilitre (ng/mL)
Interval 0.137 to 6.687
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 3.41
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.133
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+5MIN
|
58.328 Nanogram/ millilitre (ng/mL)
Interval 17.8 to 90.06
|
106.730 Nanogram/ millilitre (ng/mL)
Interval 65.44 to 153.34
|
18.575 Nanogram/ millilitre (ng/mL)
Interval 8.13 to 26.6
|
18.650 Nanogram/ millilitre (ng/mL)
Interval 18.6 to 18.7
|
102.851 Nanogram/ millilitre (ng/mL)
Interval 99.36 to 127.991
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+15MIN
|
37.845 Nanogram/ millilitre (ng/mL)
Interval 15.4 to 78.22
|
121.300 Nanogram/ millilitre (ng/mL)
Interval 57.5 to 124.41
|
16.120 Nanogram/ millilitre (ng/mL)
Interval 6.87 to 25.2
|
—
|
86.413 Nanogram/ millilitre (ng/mL)
Interval 79.637 to 110.036
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+30MIN
|
32.860 Nanogram/ millilitre (ng/mL)
Interval 13.7 to 75.2
|
78.930 Nanogram/ millilitre (ng/mL)
Interval 45.74 to 107.87
|
14.750 Nanogram/ millilitre (ng/mL)
Interval 5.76 to 21.7
|
—
|
62.879 Nanogram/ millilitre (ng/mL)
Interval 58.925 to 90.275
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+45MIN
|
28.320 Nanogram/ millilitre (ng/mL)
Interval 13.1 to 77.71
|
87.250 Nanogram/ millilitre (ng/mL)
Interval 37.25 to 97.94
|
12.550 Nanogram/ millilitre (ng/mL)
Interval 4.89 to 20.0
|
—
|
47.588 Nanogram/ millilitre (ng/mL)
Interval 38.173 to 90.417
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+1HR
|
30.325 Nanogram/ millilitre (ng/mL)
Interval 11.4 to 65.47
|
76.440 Nanogram/ millilitre (ng/mL)
Interval 35.5 to 82.84
|
11.950 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 17.4
|
—
|
40.026 Nanogram/ millilitre (ng/mL)
Interval 35.272 to 75.498
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+2HR
|
17.485 Nanogram/ millilitre (ng/mL)
Interval 5.7 to 61.87
|
41.620 Nanogram/ millilitre (ng/mL)
Interval 18.18 to 58.65
|
5.930 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 11.96
|
11.500 Nanogram/ millilitre (ng/mL)
Interval 11.3 to 11.7
|
15.285 Nanogram/ millilitre (ng/mL)
Interval 13.62 to 53.502
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+4HR
|
7.630 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 42.1
|
13.200 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 38.27
|
2.085 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 8.48
|
6.190 Nanogram/ millilitre (ng/mL)
Interval 6.16 to 6.22
|
3.917 Nanogram/ millilitre (ng/mL)
Interval 3.691 to 36.777
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+8HR
|
1.642 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 35.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 23.1
|
0.473 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 5.71
|
—
|
0.935 Nanogram/ millilitre (ng/mL)
Interval 0.732 to 12.042
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK6, EOI+24HR
|
0.201 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 17.8
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 8.67
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.711
|
—
|
0.269 Nanogram/ millilitre (ng/mL)
Interval 0.203 to 1.786
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 22.16
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 12.69
|
—
|
0.145 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.206
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+5MIN
|
43.295 Nanogram/ millilitre (ng/mL)
Interval 27.25 to 59.34
|
126.020 Nanogram/ millilitre (ng/mL)
Interval 74.63 to 173.55
|
22.990 Nanogram/ millilitre (ng/mL)
Interval 11.77 to 26.81
|
—
|
98.752 Nanogram/ millilitre (ng/mL)
Interval 84.687 to 107.093
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+15MIN
|
46.830 Nanogram/ millilitre (ng/mL)
Interval 43.32 to 50.34
|
116.030 Nanogram/ millilitre (ng/mL)
Interval 63.12 to 129.19
|
17.340 Nanogram/ millilitre (ng/mL)
Interval 10.41 to 22.36
|
—
|
90.104 Nanogram/ millilitre (ng/mL)
Interval 65.049 to 118.578
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+30MIN
|
38.160 Nanogram/ millilitre (ng/mL)
Interval 36.16 to 40.16
|
108.240 Nanogram/ millilitre (ng/mL)
Interval 56.1 to 115.62
|
11.570 Nanogram/ millilitre (ng/mL)
Interval 9.05 to 20.5
|
—
|
83.767 Nanogram/ millilitre (ng/mL)
Interval 47.615 to 94.767
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+45MIN
|
30.000 Nanogram/ millilitre (ng/mL)
Interval 23.95 to 36.05
|
85.520 Nanogram/ millilitre (ng/mL)
Interval 47.83 to 101.44
|
8.730 Nanogram/ millilitre (ng/mL)
Interval 7.44 to 15.99
|
—
|
80.187 Nanogram/ millilitre (ng/mL)
Interval 37.837 to 87.354
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, EOI+5MIN
|
71.450 Nanogram/ millilitre (ng/mL)
Interval 70.8 to 72.1
|
—
|
17.250 Nanogram/ millilitre (ng/mL)
Interval 8.12 to 34.6
|
27.400 Nanogram/ millilitre (ng/mL)
Interval 27.4 to 27.4
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, EOI+2HR
|
38.650 Nanogram/ millilitre (ng/mL)
Interval 24.4 to 52.9
|
—
|
6.210 Nanogram/ millilitre (ng/mL)
Interval 4.28 to 10.1
|
12.700 Nanogram/ millilitre (ng/mL)
Interval 12.7 to 12.7
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, EOI+4HR
|
25.150 Nanogram/ millilitre (ng/mL)
Interval 7.8 to 42.5
|
—
|
2.205 Nanogram/ millilitre (ng/mL)
Interval 1.14 to 7.0
|
7.400 Nanogram/ millilitre (ng/mL)
Interval 7.4 to 7.4
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, EOI+8HR
|
2.300 Nanogram/ millilitre (ng/mL)
Interval 2.3 to 2.3
|
—
|
0.462 Nanogram/ millilitre (ng/mL)
Interval 0.255 to 1.57
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, EOI+24HR
|
—
|
—
|
0.268 Nanogram/ millilitre (ng/mL)
Interval 0.268 to 0.268
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
5.130 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 36.49
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+5MIN
|
66.540 Nanogram/ millilitre (ng/mL)
Interval 54.24 to 78.84
|
150.260 Nanogram/ millilitre (ng/mL)
Interval 105.08 to 157.21
|
20.740 Nanogram/ millilitre (ng/mL)
Interval 20.5 to 20.98
|
—
|
98.041 Nanogram/ millilitre (ng/mL)
Interval 98.041 to 98.041
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+15MIN
|
47.080 Nanogram/ millilitre (ng/mL)
Interval 37.99 to 56.17
|
132.160 Nanogram/ millilitre (ng/mL)
Interval 69.8 to 162.59
|
20.720 Nanogram/ millilitre (ng/mL)
Interval 18.62 to 22.82
|
—
|
86.184 Nanogram/ millilitre (ng/mL)
Interval 86.184 to 86.184
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+30MIN
|
41.385 Nanogram/ millilitre (ng/mL)
Interval 40.22 to 42.55
|
111.920 Nanogram/ millilitre (ng/mL)
Interval 59.31 to 125.54
|
16.215 Nanogram/ millilitre (ng/mL)
Interval 13.43 to 19.0
|
—
|
85.491 Nanogram/ millilitre (ng/mL)
Interval 85.491 to 85.491
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+45MIN
|
29.580 Nanogram/ millilitre (ng/mL)
Interval 26.99 to 32.17
|
89.030 Nanogram/ millilitre (ng/mL)
Interval 46.41 to 122.5
|
11.150 Nanogram/ millilitre (ng/mL)
Interval 8.62 to 13.68
|
—
|
78.505 Nanogram/ millilitre (ng/mL)
Interval 78.505 to 78.505
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+1HR
|
24.850 Nanogram/ millilitre (ng/mL)
Interval 23.83 to 25.87
|
72.730 Nanogram/ millilitre (ng/mL)
Interval 36.33 to 118.15
|
5.325 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 10.65
|
—
|
61.492 Nanogram/ millilitre (ng/mL)
Interval 61.492 to 61.492
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+2HR
|
13.405 Nanogram/ millilitre (ng/mL)
Interval 11.9 to 14.91
|
64.050 Nanogram/ millilitre (ng/mL)
Interval 18.22 to 97.98
|
3.205 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 6.41
|
—
|
38.384 Nanogram/ millilitre (ng/mL)
Interval 38.384 to 38.384
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+4HR
|
2.650 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 5.3
|
19.080 Nanogram/ millilitre (ng/mL)
Interval 7.76 to 46.58
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
28.923 Nanogram/ millilitre (ng/mL)
Interval 28.923 to 28.923
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+8HR
|
—
|
20.940 Nanogram/ millilitre (ng/mL)
Interval 20.94 to 20.94
|
—
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK12, EOI+24HR
|
—
|
6.730 Nanogram/ millilitre (ng/mL)
Interval 6.73 to 6.73
|
—
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK19, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 13.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK19, EOI+5MIN
|
—
|
—
|
19.000 Nanogram/ millilitre (ng/mL)
Interval 15.7 to 31.0
|
42.400 Nanogram/ millilitre (ng/mL)
Interval 42.4 to 42.4
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK19, EOI+2HR
|
—
|
—
|
5.280 Nanogram/ millilitre (ng/mL)
Interval 3.93 to 5.39
|
24.100 Nanogram/ millilitre (ng/mL)
Interval 24.1 to 24.1
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK19, EOI+4HR
|
—
|
—
|
1.540 Nanogram/ millilitre (ng/mL)
Interval 0.849 to 2.87
|
18.800 Nanogram/ millilitre (ng/mL)
Interval 18.8 to 18.8
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK19, EOI+8HR
|
—
|
—
|
0.409 Nanogram/ millilitre (ng/mL)
Interval 0.409 to 0.409
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK55, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK55, EOI+5MIN
|
—
|
—
|
13.500 Nanogram/ millilitre (ng/mL)
Interval 13.5 to 13.5
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK55, EOI+2HR
|
—
|
—
|
5.510 Nanogram/ millilitre (ng/mL)
Interval 5.51 to 5.51
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+1HR
|
25.965 Nanogram/ millilitre (ng/mL)
Interval 24.91 to 27.02
|
75.860 Nanogram/ millilitre (ng/mL)
Interval 36.36 to 100.5
|
7.700 Nanogram/ millilitre (ng/mL)
Interval 6.76 to 12.68
|
—
|
70.788 Nanogram/ millilitre (ng/mL)
Interval 25.646 to 85.403
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+2HR
|
14.675 Nanogram/ millilitre (ng/mL)
Interval 13.17 to 16.18
|
36.110 Nanogram/ millilitre (ng/mL)
Interval 15.41 to 50.65
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 7.24
|
—
|
48.390 Nanogram/ millilitre (ng/mL)
Interval 9.266 to 54.623
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+4HR
|
3.020 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 6.04
|
20.740 Nanogram/ millilitre (ng/mL)
Interval 6.06 to 27.76
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
37.657 Nanogram/ millilitre (ng/mL)
Interval 3.645 to 41.961
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+8HR
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK9, EOI+24HR
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK10, PREDOSE
|
3.150 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 6.3
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 3.84
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, PREDOSE
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+5MIN
|
44.700 Nanogram/ millilitre (ng/mL)
Interval 25.8 to 90.77
|
103.550 Nanogram/ millilitre (ng/mL)
Interval 75.45 to 145.08
|
21.365 Nanogram/ millilitre (ng/mL)
Interval 9.75 to 49.54
|
15.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 30.0
|
111.655 Nanogram/ millilitre (ng/mL)
Interval 79.945 to 132.755
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+15MIN
|
40.700 Nanogram/ millilitre (ng/mL)
Interval 25.6 to 95.96
|
90.640 Nanogram/ millilitre (ng/mL)
Interval 64.34 to 119.48
|
18.880 Nanogram/ millilitre (ng/mL)
Interval 8.83 to 40.94
|
18.590 Nanogram/ millilitre (ng/mL)
Interval 8.58 to 28.6
|
96.102 Nanogram/ millilitre (ng/mL)
Interval 53.635 to 147.868
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+30MIN
|
36.000 Nanogram/ millilitre (ng/mL)
Interval 22.3 to 91.11
|
83.075 Nanogram/ millilitre (ng/mL)
Interval 43.28 to 102.68
|
15.800 Nanogram/ millilitre (ng/mL)
Interval 7.54 to 40.68
|
17.050 Nanogram/ millilitre (ng/mL)
Interval 8.7 to 25.4
|
78.439 Nanogram/ millilitre (ng/mL)
Interval 32.8 to 123.949
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+45MIN
|
31.420 Nanogram/ millilitre (ng/mL)
Interval 15.3 to 78.94
|
70.485 Nanogram/ millilitre (ng/mL)
Interval 39.88 to 89.59
|
13.150 Nanogram/ millilitre (ng/mL)
Interval 5.89 to 33.47
|
14.365 Nanogram/ millilitre (ng/mL)
Interval 4.83 to 23.9
|
66.000 Nanogram/ millilitre (ng/mL)
Interval 23.487 to 110.269
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+1HR
|
29.000 Nanogram/ millilitre (ng/mL)
Interval 11.2 to 75.95
|
62.310 Nanogram/ millilitre (ng/mL)
Interval 28.87 to 92.81
|
10.580 Nanogram/ millilitre (ng/mL)
Interval 5.03 to 33.62
|
21.300 Nanogram/ millilitre (ng/mL)
Interval 21.3 to 21.3
|
59.051 Nanogram/ millilitre (ng/mL)
Interval 17.933 to 124.574
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+2HR
|
16.200 Nanogram/ millilitre (ng/mL)
Interval 6.37 to 44.71
|
32.970 Nanogram/ millilitre (ng/mL)
Interval 6.42 to 74.81
|
6.090 Nanogram/ millilitre (ng/mL)
Interval 2.44 to 18.21
|
34.100 Nanogram/ millilitre (ng/mL)
Interval 16.4 to 51.8
|
39.142 Nanogram/ millilitre (ng/mL)
Interval 3.596 to 105.515
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
WEEK1, EOI+4HR
|
6.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 27.3
|
11.380 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 65.42
|
2.030 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 12.49
|
24.690 Nanogram/ millilitre (ng/mL)
Interval 8.58 to 40.8
|
12.886 Nanogram/ millilitre (ng/mL)
Interval 0.701 to 67.719
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 6, 9, 10, 12, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=17 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=14 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=2 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=7 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK1
|
145.6088 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 111.8033
|
246.7692 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 132.0408
|
47.0402 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 73.0706
|
425.3023 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 189.7100
|
247.2823 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 79.1154
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK2
|
130.5975 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 114.5345
|
297.4580 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 137.6797
|
77.8444 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 108.5440
|
173.6723 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 38.7832
|
253.8358 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 103.5394
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK3
|
150.3281 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 116.4078
|
272.8593 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 127.8989
|
69.7018 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 102.8510
|
63.1059 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 377.1988
|
198.6138 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 70.3728
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK4
|
133.7003 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 132.4949
|
318.5676 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 115.5291
|
46.2111 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 126.0831
|
338.2702 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 96.4149
|
234.0111 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 85.9781
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK5
|
149.6756 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 122.4637
|
304.3914 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 139.3329
|
46.6175 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 103.7140
|
285.9155 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 118.7575
|
203.4746 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 53.4979
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK6
|
138.8428 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 132.3027
|
245.7313 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 103.6711
|
38.6047 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 101.8073
|
—
|
175.7315 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 63.3206
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK9
|
79.7311 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
199.9995 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 61.2526
|
18.8752 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 55.5837
|
—
|
216.6902 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 91.1146
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK10
|
133.8118 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
39.0336 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 35.7876
|
—
|
—
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK12
|
84.7136 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 35.4645
|
276.5512 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 116.8407
|
19.8179 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 61.7906
|
—
|
255.0798 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
|
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
WEEK19
|
—
|
—
|
28.6164 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 6, 9, 10, 12, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=17 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=14 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=2 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=7 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK4
|
46.712 ng/mL
Geometric Coefficient of Variation 50.725
|
118.978 ng/mL
Geometric Coefficient of Variation 21.611
|
20.791 ng/mL
Geometric Coefficient of Variation 57.142
|
27.442 ng/mL
Geometric Coefficient of Variation 24.724
|
125.171 ng/mL
Geometric Coefficient of Variation 30.301
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK5
|
50.470 ng/mL
Geometric Coefficient of Variation 34.755
|
116.290 ng/mL
Geometric Coefficient of Variation 35.137
|
18.057 ng/mL
Geometric Coefficient of Variation 42.913
|
20.669 ng/mL
Geometric Coefficient of Variation 37.429
|
117.339 ng/mL
Geometric Coefficient of Variation 20.709
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK6
|
51.851 ng/mL
Geometric Coefficient of Variation 84.399
|
120.172 ng/mL
Geometric Coefficient of Variation 25.810
|
17.284 ng/mL
Geometric Coefficient of Variation 38.137
|
—
|
111.399 ng/mL
Geometric Coefficient of Variation 13.175
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK9
|
43.320 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
119.378 ng/mL
Geometric Coefficient of Variation 46.814
|
19.956 ng/mL
Geometric Coefficient of Variation 44.055
|
—
|
111.267 ng/mL
Geometric Coefficient of Variation 25.162
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK10
|
72.100 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
18.972 ng/mL
Geometric Coefficient of Variation 61.730
|
—
|
—
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK12
|
128.974 ng/mL
Geometric Coefficient of Variation 71.075
|
151.763 ng/mL
Geometric Coefficient of Variation 34.837
|
24.213 ng/mL
Geometric Coefficient of Variation 8.391
|
—
|
116.269 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK19
|
—
|
—
|
15.700 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK1
|
53.434 ng/mL
Geometric Coefficient of Variation 38.959
|
115.067 ng/mL
Geometric Coefficient of Variation 21.459
|
21.648 ng/mL
Geometric Coefficient of Variation 44.920
|
39.421 ng/mL
Geometric Coefficient of Variation 40.108
|
115.244 ng/mL
Geometric Coefficient of Variation 24.732
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK2
|
47.747 ng/mL
Geometric Coefficient of Variation 66.571
|
114.148 ng/mL
Geometric Coefficient of Variation 27.392
|
24.710 ng/mL
Geometric Coefficient of Variation 33.028
|
19.922 ng/mL
Geometric Coefficient of Variation 59.477
|
111.111 ng/mL
Geometric Coefficient of Variation 31.847
|
—
|
—
|
|
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
WEEK3
|
49.458 ng/mL
Geometric Coefficient of Variation 38.252
|
112.085 ng/mL
Geometric Coefficient of Variation 26.349
|
25.079 ng/mL
Geometric Coefficient of Variation 47.896
|
6.152 ng/mL
Geometric Coefficient of Variation 248.490
|
103.552 ng/mL
Geometric Coefficient of Variation 24.989
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 6, 9, 10, 12, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
n=17 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 Participants
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=14 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=2 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=7 Participants
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK1
|
3.9070 Hours
Geometric Coefficient of Variation 210.2296
|
1.3649 Hours
Geometric Coefficient of Variation 73.8778
|
2.6641 Hours
Geometric Coefficient of Variation 106.8910
|
9.5995 Hours
Geometric Coefficient of Variation 28.9474
|
5.8372 Hours
Geometric Coefficient of Variation 277.8089
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK2
|
2.9851 Hours
Geometric Coefficient of Variation 142.5006
|
1.9345 Hours
Geometric Coefficient of Variation 128.5751
|
4.7658 Hours
Geometric Coefficient of Variation 328.9786
|
19.3880 Hours
Geometric Coefficient of Variation 469.4324
|
3.0618 Hours
Geometric Coefficient of Variation 71.7607
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK3
|
3.3057 Hours
Geometric Coefficient of Variation 155.8241
|
1.6793 Hours
Geometric Coefficient of Variation 100.7945
|
3.7449 Hours
Geometric Coefficient of Variation 206.4953
|
2.6123 Hours
Geometric Coefficient of Variation 174.1372
|
3.6785 Hours
Geometric Coefficient of Variation 30.4604
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK4
|
2.8734 Hours
Geometric Coefficient of Variation 146.3490
|
2.1743 Hours
Geometric Coefficient of Variation 110.6625
|
3.5628 Hours
Geometric Coefficient of Variation 254.2437
|
3.2869 Hours
Geometric Coefficient of Variation 68.0644
|
5.4240 Hours
Geometric Coefficient of Variation 106.1862
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK5
|
3.6380 Hours
Geometric Coefficient of Variation 215.0417
|
2.0752 Hours
Geometric Coefficient of Variation 137.0553
|
3.3936 Hours
Geometric Coefficient of Variation 231.5664
|
4.2877 Hours
Geometric Coefficient of Variation 51.4222
|
3.1800 Hours
Geometric Coefficient of Variation 29.9556
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK6
|
3.4171 Hours
Geometric Coefficient of Variation 154.7470
|
1.9482 Hours
Geometric Coefficient of Variation 136.5929
|
2.8077 Hours
Geometric Coefficient of Variation 90.0579
|
—
|
3.1452 Hours
Geometric Coefficient of Variation 31.5377
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK9
|
1.1755 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
1.1873 Hours
Geometric Coefficient of Variation 30.5239
|
0.8472 Hours
Geometric Coefficient of Variation 46.5385
|
—
|
1.5023 Hours
Geometric Coefficient of Variation 73.2964
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK10
|
1.5753 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
1.7913 Hours
Geometric Coefficient of Variation 68.2418
|
—
|
—
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK12
|
0.8903 Hours
Geometric Coefficient of Variation 52.3388
|
1.8997 Hours
Geometric Coefficient of Variation 167.2107
|
0.7582 Hours
Geometric Coefficient of Variation 77.8995
|
—
|
1.9083 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
|
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
WEEK19
|
—
|
—
|
1.3160 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on W 1, 4, 7, 10, 13, 16, 19; EOI+5min/ 15min/ 30 min/ 45 min/1HR/ 2HR/ 4HR on W 1, 4, 7, 10, 13, 16, 19; EOI+8HR/ 24HR on W 1, 4, 7, 10, 13, 16Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=6 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+8HR
|
—
|
—
|
1.178 Nanogram/ millilitre (ng/mL)
Interval 0.823 to 1.533
|
2.970 Nanogram/ millilitre (ng/mL)
Interval 0.673 to 4.567
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+24HR
|
—
|
—
|
0.186 Nanogram/ millilitre (ng/mL)
Interval 0.128 to 0.243
|
0.667 Nanogram/ millilitre (ng/mL)
Interval 0.176 to 1.368
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+5MIN
|
—
|
—
|
11.616 Nanogram/ millilitre (ng/mL)
Interval 11.616 to 11.616
|
52.322 Nanogram/ millilitre (ng/mL)
Interval 38.977 to 65.666
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+1HR
|
—
|
—
|
6.132 Nanogram/ millilitre (ng/mL)
Interval 6.132 to 6.132
|
39.095 Nanogram/ millilitre (ng/mL)
Interval 25.038 to 53.152
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+2HR
|
—
|
—
|
3.484 Nanogram/ millilitre (ng/mL)
Interval 3.484 to 3.484
|
25.151 Nanogram/ millilitre (ng/mL)
Interval 14.376 to 35.925
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+45MIN
|
—
|
—
|
14.784 Nanogram/ millilitre (ng/mL)
Interval 13.002 to 16.565
|
25.281 Nanogram/ millilitre (ng/mL)
Interval 18.7 to 31.861
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+24HR
|
—
|
—
|
0.284 Nanogram/ millilitre (ng/mL)
Interval 0.113 to 0.455
|
0.297 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.594
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+5MIN
|
—
|
—
|
16.300 Nanogram/ millilitre (ng/mL)
Interval 11.069 to 21.53
|
72.010 Nanogram/ millilitre (ng/mL)
Interval 44.858 to 94.105
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+5MIN
|
—
|
—
|
19.656 Nanogram/ millilitre (ng/mL)
Interval 17.655 to 25.572
|
68.092 Nanogram/ millilitre (ng/mL)
Interval 49.614 to 162.468
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+15MIN
|
—
|
—
|
17.848 Nanogram/ millilitre (ng/mL)
Interval 16.17 to 23.631
|
59.686 Nanogram/ millilitre (ng/mL)
Interval 33.494 to 155.317
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+30MIN
|
—
|
—
|
16.010 Nanogram/ millilitre (ng/mL)
Interval 14.343 to 19.921
|
48.956 Nanogram/ millilitre (ng/mL)
Interval 36.096 to 125.04
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+15MIN
|
—
|
—
|
14.881 Nanogram/ millilitre (ng/mL)
Interval 10.665 to 19.097
|
59.605 Nanogram/ millilitre (ng/mL)
Interval 37.61 to 77.265
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+45MIN
|
—
|
—
|
14.122 Nanogram/ millilitre (ng/mL)
Interval 13.289 to 18.092
|
41.514 Nanogram/ millilitre (ng/mL)
Interval 24.915 to 117.454
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+1HR
|
—
|
—
|
12.503 Nanogram/ millilitre (ng/mL)
Interval 11.2 to 15.045
|
32.591 Nanogram/ millilitre (ng/mL)
Interval 19.755 to 94.943
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+2HR
|
—
|
—
|
8.103 Nanogram/ millilitre (ng/mL)
Interval 7.523 to 9.174
|
14.133 Nanogram/ millilitre (ng/mL)
Interval 8.873 to 56.505
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+4HR
|
—
|
—
|
4.324 Nanogram/ millilitre (ng/mL)
Interval 4.272 to 5.012
|
5.024 Nanogram/ millilitre (ng/mL)
Interval 1.507 to 14.038
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+8HR
|
—
|
—
|
1.306 Nanogram/ millilitre (ng/mL)
Interval 0.895 to 1.365
|
0.867 Nanogram/ millilitre (ng/mL)
Interval 0.405 to 7.079
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK1, EOI+24HR
|
—
|
—
|
0.213 Nanogram/ millilitre (ng/mL)
Interval 0.21 to 0.267
|
0.390 Nanogram/ millilitre (ng/mL)
Interval 0.101 to 3.568
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+5MIN
|
—
|
—
|
19.178 Nanogram/ millilitre (ng/mL)
Interval 15.501 to 29.51
|
79.138 Nanogram/ millilitre (ng/mL)
Interval 39.037 to 98.366
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+15MIN
|
—
|
—
|
19.738 Nanogram/ millilitre (ng/mL)
Interval 13.381 to 25.756
|
60.396 Nanogram/ millilitre (ng/mL)
Interval 40.734 to 78.122
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+30MIN
|
—
|
—
|
17.016 Nanogram/ millilitre (ng/mL)
Interval 11.846 to 23.782
|
42.864 Nanogram/ millilitre (ng/mL)
Interval 31.276 to 58.776
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+45MIN
|
—
|
—
|
15.065 Nanogram/ millilitre (ng/mL)
Interval 10.255 to 19.001
|
36.750 Nanogram/ millilitre (ng/mL)
Interval 21.772 to 42.049
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+1HR
|
—
|
—
|
14.628 Nanogram/ millilitre (ng/mL)
Interval 8.744 to 16.928
|
31.770 Nanogram/ millilitre (ng/mL)
Interval 16.324 to 34.248
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+2HR
|
—
|
—
|
9.483 Nanogram/ millilitre (ng/mL)
Interval 6.382 to 11.708
|
14.780 Nanogram/ millilitre (ng/mL)
Interval 4.748 to 16.674
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+4HR
|
—
|
—
|
3.133 Nanogram/ millilitre (ng/mL)
Interval 2.251 to 6.454
|
2.769 Nanogram/ millilitre (ng/mL)
Interval 1.98 to 4.64
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+8HR
|
—
|
—
|
1.067 Nanogram/ millilitre (ng/mL)
Interval 0.573 to 2.21
|
0.712 Nanogram/ millilitre (ng/mL)
Interval 0.392 to 1.412
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK4, EOI+24HR
|
—
|
—
|
0.172 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.415
|
0.162 Nanogram/ millilitre (ng/mL)
Interval 0.103 to 0.287
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+5MIN
|
—
|
—
|
17.996 Nanogram/ millilitre (ng/mL)
Interval 14.01 to 21.982
|
56.701 Nanogram/ millilitre (ng/mL)
Interval 39.881 to 79.572
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+15MIN
|
—
|
—
|
15.603 Nanogram/ millilitre (ng/mL)
Interval 12.06 to 19.145
|
51.354 Nanogram/ millilitre (ng/mL)
Interval 34.819 to 68.696
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+30MIN
|
—
|
—
|
16.050 Nanogram/ millilitre (ng/mL)
Interval 13.469 to 18.631
|
43.613 Nanogram/ millilitre (ng/mL)
Interval 28.577 to 50.756
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+45MIN
|
—
|
—
|
14.383 Nanogram/ millilitre (ng/mL)
Interval 12.296 to 16.469
|
34.381 Nanogram/ millilitre (ng/mL)
Interval 18.854 to 43.681
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+1HR
|
—
|
—
|
13.182 Nanogram/ millilitre (ng/mL)
Interval 11.505 to 14.858
|
30.738 Nanogram/ millilitre (ng/mL)
Interval 20.794 to 43.87
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+2HR
|
—
|
—
|
8.885 Nanogram/ millilitre (ng/mL)
Interval 8.539 to 9.23
|
17.308 Nanogram/ millilitre (ng/mL)
Interval 10.424 to 23.124
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+4HR
|
—
|
—
|
4.126 Nanogram/ millilitre (ng/mL)
Interval 2.818 to 5.433
|
4.005 Nanogram/ millilitre (ng/mL)
Interval 2.532 to 12.401
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+8HR
|
—
|
—
|
1.730 Nanogram/ millilitre (ng/mL)
Interval 1.065 to 2.394
|
0.978 Nanogram/ millilitre (ng/mL)
Interval 0.397 to 2.525
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK7, EOI+24HR
|
—
|
—
|
0.224 Nanogram/ millilitre (ng/mL)
Interval 0.109 to 0.339
|
0.249 Nanogram/ millilitre (ng/mL)
Interval 0.14 to 0.667
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.108
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+30MIN
|
—
|
—
|
14.029 Nanogram/ millilitre (ng/mL)
Interval 10.063 to 17.995
|
52.583 Nanogram/ millilitre (ng/mL)
Interval 31.784 to 60.159
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+45MIN
|
—
|
—
|
12.552 Nanogram/ millilitre (ng/mL)
Interval 9.074 to 16.029
|
53.366 Nanogram/ millilitre (ng/mL)
Interval 25.714 to 67.141
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+1HR
|
—
|
—
|
10.926 Nanogram/ millilitre (ng/mL)
Interval 8.387 to 13.465
|
44.280 Nanogram/ millilitre (ng/mL)
Interval 21.319 to 62.502
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+2HR
|
—
|
—
|
6.899 Nanogram/ millilitre (ng/mL)
Interval 6.278 to 7.519
|
29.161 Nanogram/ millilitre (ng/mL)
Interval 9.557 to 42.098
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK10, EOI+4HR
|
—
|
—
|
3.349 Nanogram/ millilitre (ng/mL)
Interval 3.052 to 3.645
|
14.945 Nanogram/ millilitre (ng/mL)
Interval 2.206 to 23.259
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+15MIN
|
—
|
—
|
9.839 Nanogram/ millilitre (ng/mL)
Interval 9.839 to 9.839
|
54.481 Nanogram/ millilitre (ng/mL)
Interval 36.068 to 72.893
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+30MIN
|
—
|
—
|
8.136 Nanogram/ millilitre (ng/mL)
Interval 8.136 to 8.136
|
45.104 Nanogram/ millilitre (ng/mL)
Interval 31.641 to 58.567
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+45MIN
|
—
|
—
|
6.717 Nanogram/ millilitre (ng/mL)
Interval 6.717 to 6.717
|
42.186 Nanogram/ millilitre (ng/mL)
Interval 26.765 to 57.606
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+4HR
|
—
|
—
|
—
|
15.093 Nanogram/ millilitre (ng/mL)
Interval 7.481 to 22.704
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+8HR
|
—
|
—
|
0.380 Nanogram/ millilitre (ng/mL)
Interval 0.38 to 0.38
|
5.522 Nanogram/ millilitre (ng/mL)
Interval 2.244 to 8.799
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK13, EOI+24HR
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
1.165 Nanogram/ millilitre (ng/mL)
Interval 0.54 to 1.79
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+5MIN
|
—
|
—
|
20.721 Nanogram/ millilitre (ng/mL)
Interval 16.66 to 24.781
|
52.777 Nanogram/ millilitre (ng/mL)
Interval 51.4 to 54.153
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+15MIN
|
—
|
—
|
18.115 Nanogram/ millilitre (ng/mL)
Interval 14.726 to 21.504
|
37.137 Nanogram/ millilitre (ng/mL)
Interval 36.8 to 37.474
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+30MIN
|
—
|
—
|
16.677 Nanogram/ millilitre (ng/mL)
Interval 14.13 to 19.224
|
25.695 Nanogram/ millilitre (ng/mL)
Interval 25.1 to 26.29
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+1HR
|
—
|
—
|
12.920 Nanogram/ millilitre (ng/mL)
Interval 12.095 to 13.744
|
18.798 Nanogram/ millilitre (ng/mL)
Interval 15.4 to 22.195
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+2HR
|
—
|
—
|
9.099 Nanogram/ millilitre (ng/mL)
Interval 7.608 to 10.59
|
13.221 Nanogram/ millilitre (ng/mL)
Interval 5.54 to 20.902
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+4HR
|
—
|
—
|
5.529 Nanogram/ millilitre (ng/mL)
Interval 4.391 to 6.667
|
5.104 Nanogram/ millilitre (ng/mL)
Interval 1.41 to 8.798
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK16, EOI+8HR
|
—
|
—
|
1.455 Nanogram/ millilitre (ng/mL)
Interval 0.388 to 2.521
|
1.806 Nanogram/ millilitre (ng/mL)
Interval 0.23 to 3.382
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, PREDOSE
|
—
|
—
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
0.000 Nanogram/ millilitre (ng/mL)
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+5MIN
|
—
|
—
|
24.762 Nanogram/ millilitre (ng/mL)
Interval 24.762 to 24.762
|
48.719 Nanogram/ millilitre (ng/mL)
Interval 48.719 to 48.719
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+15MIN
|
—
|
—
|
20.382 Nanogram/ millilitre (ng/mL)
Interval 20.382 to 20.382
|
41.813 Nanogram/ millilitre (ng/mL)
Interval 41.813 to 41.813
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+30MIN
|
—
|
—
|
19.166 Nanogram/ millilitre (ng/mL)
Interval 19.166 to 19.166
|
33.774 Nanogram/ millilitre (ng/mL)
Interval 33.774 to 33.774
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+45MIN
|
—
|
—
|
15.938 Nanogram/ millilitre (ng/mL)
Interval 15.938 to 15.938
|
28.790 Nanogram/ millilitre (ng/mL)
Interval 28.79 to 28.79
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+1HR
|
—
|
—
|
13.778 Nanogram/ millilitre (ng/mL)
Interval 13.778 to 13.778
|
22.454 Nanogram/ millilitre (ng/mL)
Interval 22.454 to 22.454
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+2HR
|
—
|
—
|
7.581 Nanogram/ millilitre (ng/mL)
Interval 7.581 to 7.581
|
21.388 Nanogram/ millilitre (ng/mL)
Interval 21.388 to 21.388
|
—
|
—
|
—
|
|
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
WEEK19, EOI+4HR
|
—
|
—
|
4.616 Nanogram/ millilitre (ng/mL)
Interval 4.616 to 4.616
|
10.894 Nanogram/ millilitre (ng/mL)
Interval 10.894 to 10.894
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 16, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK1
|
—
|
—
|
113.1657 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 7.8510
|
145.2959 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 49.6241
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK4
|
—
|
—
|
87.6701 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 97.5597
|
120.1116 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 37.5649
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK7
|
—
|
—
|
108.6757 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 46.0604
|
160.3952 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 60.7743
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK10
|
—
|
—
|
55.1481 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 20.7267
|
227.9506 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 144.4144
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK13
|
—
|
—
|
24.5659 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
262.4978 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 16.2226
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK16
|
—
|
—
|
80.1101 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 3.0157
|
96.6895 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 103.2832
|
—
|
—
|
—
|
|
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
WEEK19
|
—
|
—
|
47.0437 Hours*Nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 16, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK1
|
—
|
—
|
20.703 ng/mL
Geometric Coefficient of Variation 19.236
|
66.892 ng/mL
Geometric Coefficient of Variation 24.171
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK4
|
—
|
—
|
20.823 ng/mL
Geometric Coefficient of Variation 33.402
|
79.308 ng/mL
Geometric Coefficient of Variation 21.611
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK7
|
—
|
—
|
17.549 ng/mL
Geometric Coefficient of Variation 32.677
|
56.320 ng/mL
Geometric Coefficient of Variation 30.480
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK10
|
—
|
—
|
15.437 ng/mL
Geometric Coefficient of Variation 49.771
|
67.238 ng/mL
Geometric Coefficient of Variation 38.878
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK13
|
—
|
—
|
11.616 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
53.302 ng/mL
Geometric Coefficient of Variation 46.526
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK16
|
—
|
—
|
20.319 ng/mL
Geometric Coefficient of Variation 28.639
|
52.759 ng/mL
Geometric Coefficient of Variation 3.691
|
—
|
—
|
—
|
|
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
WEEK19
|
—
|
—
|
24.762 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 16, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK1
|
—
|
—
|
3.3703 Hours
Geometric Coefficient of Variation 8.6696
|
3.3373 Hours
Geometric Coefficient of Variation 26.7810
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK4
|
—
|
—
|
3.0907 Hours
Geometric Coefficient of Variation 64.7708
|
3.2810 Hours
Geometric Coefficient of Variation 97.7614
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK7
|
—
|
—
|
4.3622 Hours
Geometric Coefficient of Variation 8.6103
|
7.5933 Hours
Geometric Coefficient of Variation 703.4471
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK10
|
—
|
—
|
3.8978 Hours
Geometric Coefficient of Variation 37.0772
|
4.0823 Hours
Geometric Coefficient of Variation 26.7208
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK13
|
—
|
—
|
1.6765 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
4.7440 Hours
Geometric Coefficient of Variation 42.2168
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK16
|
—
|
—
|
3.5409 Hours
Geometric Coefficient of Variation 35.5513
|
2.3492 Hours
Geometric Coefficient of Variation 146.8761
|
—
|
—
|
—
|
|
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
WEEK19
|
—
|
—
|
1.4041 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,EOI+5min/2HR/4HR on W 1 to 5, 7, 10, 13, 19, 37, 55; EOI+15min/ 30min/ 45 min/ 1HR on W 1, 4, 7; EOI+8HR on W 1 to 5, 7, 10, 13, 19; EOI+24HR on W 1 to 5, 7, 10Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=10 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.211
|
0.000 ng/mL
Interval 0.0 to 0.17
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, EOI+5MIN
|
—
|
—
|
22.550 ng/mL
Interval 20.9 to 24.2
|
49.700 ng/mL
Interval 32.9 to 58.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, EOI+24HR
|
—
|
—
|
—
|
2.550 ng/mL
Interval 2.04 to 3.06
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 1.16
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+15MIN
|
—
|
—
|
19.200 ng/mL
Interval 19.2 to 19.2
|
40.650 ng/mL
Interval 28.5 to 74.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+2HR
|
—
|
—
|
6.990 ng/mL
Interval 6.99 to 6.99
|
18.400 ng/mL
Interval 4.61 to 55.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+8HR
|
—
|
—
|
0.463 ng/mL
Interval 0.463 to 0.463
|
2.340 ng/mL
Interval 0.294 to 11.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.528 ng/mL
Interval 0.0 to 3.42
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, EOI+5MIN
|
—
|
—
|
38.000 ng/mL
Interval 38.0 to 38.0
|
49.700 ng/mL
Interval 39.2 to 57.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, EOI+2HR
|
—
|
—
|
9.940 ng/mL
Interval 9.94 to 9.94
|
17.550 ng/mL
Interval 5.95 to 25.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, EOI+4HR
|
—
|
—
|
4.570 ng/mL
Interval 4.57 to 4.57
|
6.710 ng/mL
Interval 1.34 to 17.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, EOI+8HR
|
—
|
—
|
0.782 ng/mL
Interval 0.782 to 0.782
|
4.840 ng/mL
Interval 1.3 to 8.86
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13, EOI+5MIN
|
—
|
—
|
22.100 ng/mL
Interval 22.1 to 22.1
|
49.950 ng/mL
Interval 42.3 to 58.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13, EOI+2HR
|
—
|
—
|
9.220 ng/mL
Interval 9.22 to 9.22
|
22.900 ng/mL
Interval 3.31 to 45.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13, EOI+4HR
|
—
|
—
|
5.110 ng/mL
Interval 5.11 to 5.11
|
10.120 ng/mL
Interval 0.627 to 20.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13, EOI+8HR
|
—
|
—
|
1.140 ng/mL
Interval 1.14 to 1.14
|
4.825 ng/mL
Interval 3.78 to 12.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19, PREDOSE
|
—
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.961
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19, EOI+5MIN
|
—
|
—
|
—
|
44.700 ng/mL
Interval 42.9 to 64.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19, EOI+2HR
|
—
|
—
|
—
|
17.400 ng/mL
Interval 4.83 to 38.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19, EOI+4HR
|
—
|
—
|
—
|
6.090 ng/mL
Interval 0.678 to 34.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19, EOI+8HR
|
—
|
—
|
—
|
21.800 ng/mL
Interval 21.8 to 21.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+4HR
|
—
|
—
|
7.735 ng/mL
Interval 5.36 to 9.62
|
14.650 ng/mL
Interval 0.81 to 44.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+8HR
|
—
|
—
|
2.580 ng/mL
Interval 0.631 to 3.92
|
5.880 ng/mL
Interval 0.158 to 17.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+24HR
|
—
|
—
|
0.390 ng/mL
Interval 0.178 to 0.764
|
1.007 ng/mL
Interval 0.0 to 3.71
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.165
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, EOI+5MIN
|
—
|
—
|
19.250 ng/mL
Interval 10.2 to 26.2
|
50.300 ng/mL
Interval 31.3 to 91.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, EOI+2HR
|
—
|
—
|
14.900 ng/mL
Interval 9.4 to 16.0
|
25.550 ng/mL
Interval 8.6 to 57.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, EOI+4HR
|
—
|
—
|
10.105 ng/mL
Interval 4.48 to 11.4
|
15.100 ng/mL
Interval 1.84 to 40.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, EOI+8HR
|
—
|
—
|
5.105 ng/mL
Interval 1.39 to 8.46
|
9.830 ng/mL
Interval 2.06 to 21.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2, EOI+24HR
|
—
|
—
|
—
|
3.915 ng/mL
Interval 3.46 to 4.37
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, EOI+2HR
|
—
|
—
|
17.600 ng/mL
Interval 10.2 to 18.2
|
25.300 ng/mL
Interval 6.7 to 41.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, EOI+4HR
|
—
|
—
|
12.800 ng/mL
Interval 5.93 to 14.2
|
14.000 ng/mL
Interval 1.3 to 31.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3, EOI+8HR
|
—
|
—
|
6.470 ng/mL
Interval 2.77 to 10.2
|
6.535 ng/mL
Interval 2.16 to 15.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+5MIN
|
—
|
—
|
27.950 ng/mL
Interval 19.2 to 45.7
|
39.400 ng/mL
Interval 27.4 to 67.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+15MIN
|
—
|
—
|
24.950 ng/mL
Interval 19.8 to 29.5
|
35.550 ng/mL
Interval 23.8 to 55.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+30MIN
|
—
|
—
|
25.800 ng/mL
Interval 16.3 to 31.3
|
31.100 ng/mL
Interval 18.4 to 49.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+45MIN
|
—
|
—
|
21.150 ng/mL
Interval 17.3 to 25.1
|
27.600 ng/mL
Interval 13.7 to 43.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+1HR
|
—
|
—
|
23.850 ng/mL
Interval 16.3 to 24.7
|
25.650 ng/mL
Interval 9.86 to 34.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+2HR
|
—
|
—
|
18.100 ng/mL
Interval 12.6 to 21.8
|
19.700 ng/mL
Interval 3.84 to 21.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+4HR
|
—
|
—
|
8.610 ng/mL
Interval 7.75 to 17.7
|
10.300 ng/mL
Interval 0.867 to 13.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+8HR
|
—
|
—
|
4.275 ng/mL
Interval 1.14 to 14.1
|
3.125 ng/mL
Interval 0.256 to 6.47
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4, EOI+24HR
|
—
|
—
|
0.675 ng/mL
Interval 0.314 to 10.0
|
0.677 ng/mL
Interval 0.0 to 1.04
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, EOI+5MIN
|
—
|
—
|
16.300 ng/mL
Interval 16.3 to 16.3
|
45.250 ng/mL
Interval 34.9 to 58.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, EOI+2HR
|
—
|
—
|
10.375 ng/mL
Interval 9.25 to 11.5
|
19.050 ng/mL
Interval 9.38 to 23.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, EOI+4HR
|
—
|
—
|
5.670 ng/mL
Interval 3.82 to 7.52
|
8.720 ng/mL
Interval 2.16 to 17.2
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, EOI+8HR
|
—
|
—
|
2.484 ng/mL
Interval 0.938 to 4.03
|
3.130 ng/mL
Interval 0.937 to 14.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5, EOI+24HR
|
—
|
—
|
—
|
0.719 ng/mL
Interval 0.237 to 1.2
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 43.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+5MIN
|
—
|
—
|
19.600 ng/mL
Interval 19.6 to 19.6
|
45.950 ng/mL
Interval 38.6 to 79.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+30MIN
|
—
|
—
|
15.000 ng/mL
Interval 15.0 to 15.0
|
36.750 ng/mL
Interval 24.9 to 66.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+45MIN
|
—
|
—
|
12.000 ng/mL
Interval 12.0 to 12.0
|
32.900 ng/mL
Interval 16.8 to 61.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+1HR
|
—
|
—
|
10.200 ng/mL
Interval 10.2 to 10.2
|
29.500 ng/mL
Interval 11.5 to 60.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7, EOI+4HR
|
—
|
—
|
3.090 ng/mL
Interval 3.09 to 3.09
|
8.515 ng/mL
Interval 0.92 to 34.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10, EOI+24HR
|
—
|
—
|
—
|
0.250 ng/mL
Interval 0.25 to 0.25
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK37, PREDOSE
|
—
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK37, EOI+5MIN
|
—
|
—
|
—
|
51.400 ng/mL
Interval 51.4 to 51.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK37, EOI+2HR
|
—
|
—
|
—
|
16.100 ng/mL
Interval 16.1 to 16.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK37, EOI+4HR
|
—
|
—
|
—
|
6.150 ng/mL
Interval 6.15 to 6.15
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK55, PREDOSE
|
—
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK55, EOI+5MIN
|
—
|
—
|
—
|
123.000 ng/mL
Interval 123.0 to 123.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK55, EOI+2HR
|
—
|
—
|
—
|
10.600 ng/mL
Interval 10.6 to 10.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK55, EOI+4HR
|
—
|
—
|
—
|
3.310 ng/mL
Interval 3.31 to 3.31
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+45MIN
|
—
|
—
|
17.550 ng/mL
Interval 17.0 to 18.6
|
39.600 ng/mL
Interval 14.2 to 68.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+1HR
|
—
|
—
|
18.050 ng/mL
Interval 15.6 to 22.3
|
34.800 ng/mL
Interval 12.1 to 67.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+2HR
|
—
|
—
|
12.400 ng/mL
Interval 9.52 to 14.8
|
25.550 ng/mL
Interval 3.63 to 55.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+5MIN
|
—
|
—
|
26.350 ng/mL
Interval 14.3 to 28.8
|
54.750 ng/mL
Interval 26.6 to 86.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+15MIN
|
—
|
—
|
23.150 ng/mL
Interval 11.9 to 23.7
|
50.500 ng/mL
Interval 21.4 to 76.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1, EOI+30MIN
|
—
|
—
|
20.450 ng/mL
Interval 19.8 to 21.3
|
43.600 ng/mL
Interval 19.4 to 76.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 5, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=9 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3
|
—
|
—
|
326.3424 h*ng/mL
Geometric Coefficient of Variation 105.6259
|
310.4697 h*ng/mL
Geometric Coefficient of Variation 81.1473
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4
|
—
|
—
|
216.7790 h*ng/mL
Geometric Coefficient of Variation 129.0498
|
130.8498 h*ng/mL
Geometric Coefficient of Variation 76.6372
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5
|
—
|
—
|
93.7275 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
128.9958 h*ng/mL
Geometric Coefficient of Variation 39.4126
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7
|
—
|
—
|
43.3152 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
130.9849 h*ng/mL
Geometric Coefficient of Variation 80.5132
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1
|
—
|
—
|
105.7925 h*ng/mL
Geometric Coefficient of Variation 37.9802
|
216.5303 h*ng/mL
Geometric Coefficient of Variation 118.8420
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2
|
—
|
—
|
271.1541 h*ng/mL
Geometric Coefficient of Variation 167.9069
|
471.1217 h*ng/mL
Geometric Coefficient of Variation 96.1181
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10
|
—
|
—
|
69.6510 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
122.3525 h*ng/mL
Geometric Coefficient of Variation 31.6306
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13
|
—
|
—
|
87.5461 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
171.3085 h*ng/mL
Geometric Coefficient of Variation 31.4407
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19
|
—
|
—
|
—
|
476.8171 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 5, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=9 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1
|
—
|
—
|
25.829 ng/mL
Geometric Coefficient of Variation 11.287
|
51.212 ng/mL
Geometric Coefficient of Variation 31.808
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19
|
—
|
—
|
—
|
42.900 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2
|
—
|
—
|
17.709 ng/mL
Geometric Coefficient of Variation 44.248
|
40.056 ng/mL
Geometric Coefficient of Variation 72.883
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3
|
—
|
—
|
20.725 ng/mL
Geometric Coefficient of Variation 16.041
|
44.277 ng/mL
Geometric Coefficient of Variation 29.284
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4
|
—
|
—
|
29.271 ng/mL
Geometric Coefficient of Variation 35.456
|
41.366 ng/mL
Geometric Coefficient of Variation 31.911
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5
|
—
|
—
|
16.300 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
42.791 ng/mL
Geometric Coefficient of Variation 19.418
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7
|
—
|
—
|
19.600 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
49.347 ng/mL
Geometric Coefficient of Variation 27.385
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10
|
—
|
—
|
38.000 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
51.623 ng/mL
Geometric Coefficient of Variation 17.632
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13
|
—
|
—
|
22.100 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
50.660 ng/mL
Geometric Coefficient of Variation 10.597
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to 5, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=9 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1
|
—
|
—
|
4.9496 Hours
Geometric Coefficient of Variation 25.3441
|
6.6082 Hours
Geometric Coefficient of Variation 97.7169
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2
|
—
|
—
|
5.4788 Hours
Geometric Coefficient of Variation 163.2744
|
3.2754 Hours
Geometric Coefficient of Variation 147.9302
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3
|
—
|
—
|
8.0669 Hours
Geometric Coefficient of Variation 323.3053
|
2.3642 Hours
Geometric Coefficient of Variation 72.3718
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4
|
—
|
—
|
9.9205 Hours
Geometric Coefficient of Variation 148.2505
|
3.7841 Hours
Geometric Coefficient of Variation 83.5863
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5
|
—
|
—
|
3.8954 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
2.5329 Hours
Geometric Coefficient of Variation 39.3756
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7
|
—
|
—
|
1.7032 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
5.5454 Hours
Geometric Coefficient of Variation 43.6477
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10
|
—
|
—
|
1.8660 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
2.5380 Hours
Geometric Coefficient of Variation 40.5521
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK13
|
—
|
—
|
2.2804 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
2.3912 Hours
Geometric Coefficient of Variation 21.7772
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19
|
—
|
—
|
—
|
6.7964 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and EOI+5min/ 2HR/ 4HR on W 1, 2, 5, 6, 8, 11, 14, 20, 38; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1 and 8; EOI+8HR in W 1, 2, 5, 6, 8; EOI+24HR on W 1, 2, 5, 8.Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.181
|
9.210 ng/mL
Interval 9.21 to 9.21
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, EOI+5MIN
|
—
|
—
|
14.100 ng/mL
Interval 8.99 to 15.6
|
82.500 ng/mL
Interval 82.5 to 82.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, EOI+2HR
|
—
|
—
|
6.910 ng/mL
Interval 6.57 to 9.94
|
29.800 ng/mL
Interval 29.8 to 29.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, EOI+4HR
|
—
|
—
|
3.750 ng/mL
Interval 1.85 to 5.18
|
15.100 ng/mL
Interval 15.1 to 15.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, EOI+8HR
|
—
|
—
|
1.440 ng/mL
Interval 0.444 to 1.6
|
5.740 ng/mL
Interval 5.74 to 5.74
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5, EOI+24HR
|
—
|
—
|
0.144 ng/mL
Interval 0.0 to 0.238
|
0.571 ng/mL
Interval 0.571 to 0.571
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+5MIN
|
—
|
—
|
18.100 ng/mL
Interval 12.0 to 21.3
|
64.400 ng/mL
Interval 64.4 to 64.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+15MIN
|
—
|
—
|
17.400 ng/mL
Interval 14.4 to 18.7
|
52.900 ng/mL
Interval 52.9 to 52.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK11, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK11, EOI+5MIN
|
—
|
—
|
15.100 ng/mL
Interval 8.82 to 20.8
|
68.300 ng/mL
Interval 68.3 to 68.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK20, EOI+2HR
|
—
|
—
|
11.600 ng/mL
Interval 11.6 to 11.6
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK20, EOI+4HR
|
—
|
—
|
6.390 ng/mL
Interval 6.39 to 6.39
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+5MIN
|
—
|
—
|
19.600 ng/mL
Interval 9.06 to 20.3
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+15MIN
|
—
|
—
|
19.000 ng/mL
Interval 17.4 to 19.2
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+30MIN
|
—
|
—
|
15.900 ng/mL
Interval 14.7 to 18.1
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+45MIN
|
—
|
—
|
13.700 ng/mL
Interval 12.0 to 16.3
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+1HR
|
—
|
—
|
11.700 ng/mL
Interval 10.5 to 14.1
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+2HR
|
—
|
—
|
8.360 ng/mL
Interval 6.75 to 9.97
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+4HR
|
—
|
—
|
2.290 ng/mL
Interval 2.0 to 5.66
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+6HR
|
—
|
—
|
0.838 ng/mL
Interval 0.765 to 2.98
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+8HR
|
—
|
—
|
0.374 ng/mL
Interval 0.363 to 1.64
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1, EOI+24HR
|
—
|
—
|
0.204 ng/mL
Interval 0.0 to 0.329
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.464 ng/mL
Interval 0.464 to 0.464
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, EOI+5MIN
|
—
|
—
|
12.200 ng/mL
Interval 8.6 to 18.3
|
18.700 ng/mL
Interval 18.7 to 18.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, EOI+2HR
|
—
|
—
|
5.930 ng/mL
Interval 3.28 to 8.68
|
17.200 ng/mL
Interval 17.2 to 17.2
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, EOI+4HR
|
—
|
—
|
2.140 ng/mL
Interval 1.19 to 5.03
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2, EOI+8HR
|
—
|
—
|
0.425 ng/mL
Interval 0.208 to 1.96
|
16.300 ng/mL
Interval 16.3 to 16.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6, EOI+5MIN
|
—
|
—
|
17.400 ng/mL
Interval 13.5 to 20.6
|
53.000 ng/mL
Interval 53.0 to 53.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6, EOI+2HR
|
—
|
—
|
7.790 ng/mL
Interval 5.62 to 7.84
|
27.300 ng/mL
Interval 27.3 to 27.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6, EOI+4HR
|
—
|
—
|
3.430 ng/mL
Interval 1.57 to 4.37
|
13.000 ng/mL
Interval 13.0 to 13.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6, EOI+8HR
|
—
|
—
|
1.500 ng/mL
Interval 1.39 to 1.61
|
5.670 ng/mL
Interval 5.67 to 5.67
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+30MIN
|
—
|
—
|
14.200 ng/mL
Interval 11.1 to 18.7
|
50.500 ng/mL
Interval 50.5 to 50.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+45MIN
|
—
|
—
|
11.700 ng/mL
Interval 9.99 to 16.0
|
43.800 ng/mL
Interval 43.8 to 43.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+1HR
|
—
|
—
|
10.400 ng/mL
Interval 8.66 to 14.8
|
40.000 ng/mL
Interval 40.0 to 40.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+2HR
|
—
|
—
|
6.300 ng/mL
Interval 4.81 to 10.2
|
26.600 ng/mL
Interval 26.6 to 26.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+4HR
|
—
|
—
|
1.700 ng/mL
Interval 1.56 to 5.57
|
11.900 ng/mL
Interval 11.9 to 11.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+6HR
|
—
|
—
|
1.040 ng/mL
Interval 0.563 to 3.31
|
7.130 ng/mL
Interval 7.13 to 7.13
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+8HR
|
—
|
—
|
0.626 ng/mL
Interval 0.269 to 2.16
|
5.170 ng/mL
Interval 5.17 to 5.17
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.309
|
0.548 ng/mL
Interval 0.548 to 0.548
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK11, EOI+2HR
|
—
|
—
|
8.790 ng/mL
Interval 3.99 to 10.8
|
28.800 ng/mL
Interval 28.8 to 28.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK11, EOI+4HR
|
—
|
—
|
4.910 ng/mL
Interval 1.31 to 6.53
|
14.300 ng/mL
Interval 14.3 to 14.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK14, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK14, EOI+5MIN
|
—
|
—
|
10.990 ng/mL
Interval 5.48 to 16.5
|
56.800 ng/mL
Interval 56.8 to 56.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK14, EOI+2HR
|
—
|
—
|
7.010 ng/mL
Interval 4.8 to 9.22
|
12.500 ng/mL
Interval 12.5 to 12.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK14, EOI+4HR
|
—
|
—
|
2.515 ng/mL
Interval 1.73 to 3.3
|
6.850 ng/mL
Interval 6.85 to 6.85
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK20, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK20, EOI+5MIN
|
—
|
—
|
19.100 ng/mL
Interval 19.1 to 19.1
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK38, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK38, EOI+5MIN
|
—
|
—
|
19.300 ng/mL
Interval 19.3 to 19.3
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK38, EOI+2HR
|
—
|
—
|
6.800 ng/mL
Interval 6.8 to 6.8
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK38, EOI+4HR
|
—
|
—
|
2.030 ng/mL
Interval 2.03 to 2.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 5, 6, 8Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6
|
—
|
—
|
48.4490 h*ng/mL
Geometric Coefficient of Variation 7.7001
|
163.2896 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8
|
—
|
—
|
44.6483 h*ng/mL
Geometric Coefficient of Variation 53.3204
|
187.0690 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1
|
—
|
—
|
61.7410 h*ng/mL
Geometric Coefficient of Variation 41.6380
|
—
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2
|
—
|
—
|
35.1903 h*ng/mL
Geometric Coefficient of Variation 67.6550
|
561.8580 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5
|
—
|
—
|
50.7155 h*ng/mL
Geometric Coefficient of Variation 51.4681
|
262.5058 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 5, 6, 8Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1
|
—
|
—
|
19.695 ng/mL
Geometric Coefficient of Variation 2.817
|
—
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2
|
—
|
—
|
12.429 ng/mL
Geometric Coefficient of Variation 39.182
|
18.700 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5
|
—
|
—
|
12.552 ng/mL
Geometric Coefficient of Variation 29.984
|
82.500 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6
|
—
|
—
|
15.326 ng/mL
Geometric Coefficient of Variation 18.090
|
53.000 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8
|
—
|
—
|
18.860 ng/mL
Geometric Coefficient of Variation 10.751
|
64.400 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 5, 6, 8Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK1
|
—
|
—
|
2.8013 Hours
Geometric Coefficient of Variation 71.6405
|
—
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK2
|
—
|
—
|
2.1751 Hours
Geometric Coefficient of Variation 65.5517
|
22.0749 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK5
|
—
|
—
|
2.9851 Hours
Geometric Coefficient of Variation 75.7387
|
4.4441 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK6
|
—
|
—
|
2.2228 Hours
Geometric Coefficient of Variation 0.3535
|
2.1489 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
WEEK8
|
—
|
—
|
2.1554 Hours
Geometric Coefficient of Variation 97.4160
|
4.4423 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on W 1, 4, 7, 10, 13, 19, 37, 55, 73, 91; EOI+5min/ 4HR on W 1, 4, 7, 10, 13, 19, 37, 55, 91; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1, 4, 7; EOI+2HR on W 1, 4, 7, 10, 13, 19, 37, 55, 73; EOI+8HR/24 HR on W 1, 4, 7, 10, 13, 19, 91Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=12 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+2HR
|
—
|
—
|
4.260 ng/mL
Interval 3.09 to 10.5
|
16.050 ng/mL
Interval 2.4 to 30.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+4HR
|
—
|
—
|
1.298 ng/mL
Interval 0.514 to 4.55
|
6.055 ng/mL
Interval 0.608 to 25.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+6HR
|
—
|
—
|
0.512 ng/mL
Interval 0.201 to 1.94
|
2.745 ng/mL
Interval 0.28 to 18.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+2HR
|
—
|
—
|
4.130 ng/mL
Interval 1.43 to 15.0
|
16.250 ng/mL
Interval 7.22 to 25.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+4HR
|
—
|
—
|
0.847 ng/mL
Interval 0.223 to 5.63
|
6.820 ng/mL
Interval 1.79 to 16.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+6HR
|
—
|
—
|
0.225 ng/mL
Interval 0.122 to 0.328
|
3.610 ng/mL
Interval 0.692 to 16.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+8HR
|
—
|
—
|
0.137 ng/mL
Interval 0.0 to 1.94
|
2.040 ng/mL
Interval 0.31 to 9.71
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, EOI+8HR
|
—
|
—
|
—
|
17.500 ng/mL
Interval 17.5 to 17.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, EOI+24HR
|
—
|
—
|
—
|
3.490 ng/mL
Interval 3.49 to 3.49
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK37, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK37, EOI+5MIN
|
—
|
—
|
27.200 ng/mL
Interval 27.2 to 27.2
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK37, EOI+2HR
|
—
|
—
|
3.280 ng/mL
Interval 3.28 to 3.28
|
20.100 ng/mL
Interval 20.1 to 20.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK37, EOI+4HR
|
—
|
—
|
0.605 ng/mL
Interval 0.605 to 0.605
|
7.430 ng/mL
Interval 7.43 to 7.43
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK55, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK55, EOI+5MIN
|
—
|
—
|
22.700 ng/mL
Interval 22.7 to 22.7
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK55, EOI+2HR
|
—
|
—
|
2.050 ng/mL
Interval 2.05 to 2.05
|
17.300 ng/mL
Interval 17.3 to 17.3
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK55, EOI+4HR
|
—
|
—
|
0.338 ng/mL
Interval 0.338 to 0.338
|
8.660 ng/mL
Interval 8.66 to 8.66
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK73, PREDOSE
|
—
|
—
|
0.204 ng/mL
Interval 0.204 to 0.204
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+15MIN
|
—
|
—
|
20.550 ng/mL
Interval 18.1 to 22.7
|
39.550 ng/mL
Interval 20.3 to 61.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+30MIN
|
—
|
—
|
16.600 ng/mL
Interval 15.3 to 17.1
|
34.050 ng/mL
Interval 15.9 to 56.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+45MIN
|
—
|
—
|
13.100 ng/mL
Interval 12.3 to 15.1
|
29.550 ng/mL
Interval 12.0 to 49.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+1HR
|
—
|
—
|
10.355 ng/mL
Interval 9.3 to 13.0
|
26.550 ng/mL
Interval 9.7 to 40.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+8HR
|
—
|
—
|
0.245 ng/mL
Interval 0.167 to 0.952
|
1.160 ng/mL
Interval 0.14 to 15.1
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.265
|
0.302 ng/mL
Interval 0.0 to 6.66
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+5MIN
|
—
|
—
|
24.200 ng/mL
Interval 22.7 to 26.0
|
42.400 ng/mL
Interval 31.4 to 56.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+15MIN
|
—
|
—
|
20.800 ng/mL
Interval 18.2 to 24.3
|
40.900 ng/mL
Interval 25.2 to 50.2
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+30MIN
|
—
|
—
|
16.050 ng/mL
Interval 13.7 to 18.7
|
34.700 ng/mL
Interval 19.1 to 40.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+45MIN
|
—
|
—
|
12.800 ng/mL
Interval 9.76 to 16.0
|
31.300 ng/mL
Interval 15.3 to 38.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+1HR
|
—
|
—
|
10.370 ng/mL
Interval 6.68 to 17.0
|
28.200 ng/mL
Interval 12.1 to 34.2
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+2HR
|
—
|
—
|
3.905 ng/mL
Interval 0.243 to 11.0
|
16.650 ng/mL
Interval 5.23 to 25.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+4HR
|
—
|
—
|
1.064 ng/mL
Interval 0.237 to 4.09
|
6.095 ng/mL
Interval 1.22 to 20.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+6HR
|
—
|
—
|
0.355 ng/mL
Interval 0.141 to 2.0
|
2.360 ng/mL
Interval 0.471 to 14.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+8HR
|
—
|
—
|
0.198 ng/mL
Interval 0.114 to 1.11
|
1.141 ng/mL
Interval 0.299 to 11.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.266
|
0.221 ng/mL
Interval 0.0 to 2.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 11.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+5MIN
|
—
|
—
|
21.400 ng/mL
Interval 13.7 to 29.2
|
39.800 ng/mL
Interval 28.9 to 52.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+15MIN
|
—
|
—
|
18.300 ng/mL
Interval 14.8 to 31.8
|
34.300 ng/mL
Interval 12.9 to 49.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+30MIN
|
—
|
—
|
14.500 ng/mL
Interval 6.86 to 30.6
|
28.100 ng/mL
Interval 6.61 to 40.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+45MIN
|
—
|
—
|
11.400 ng/mL
Interval 6.43 to 24.1
|
26.400 ng/mL
Interval 2.6 to 38.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+1HR
|
—
|
—
|
9.080 ng/mL
Interval 5.18 to 20.8
|
22.900 ng/mL
Interval 0.464 to 32.4
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.41
|
0.482 ng/mL
Interval 0.114 to 5.34
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.159
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, EOI+5MIN
|
—
|
—
|
22.900 ng/mL
Interval 22.0 to 34.5
|
28.800 ng/mL
Interval 24.1 to 47.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, EOI+2HR
|
—
|
—
|
4.270 ng/mL
Interval 2.03 to 13.8
|
15.550 ng/mL
Interval 8.03 to 25.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, EOI+4HR
|
—
|
—
|
1.080 ng/mL
Interval 0.314 to 6.02
|
7.200 ng/mL
Interval 2.74 to 14.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1, EOI+5MIN
|
—
|
—
|
23.100 ng/mL
Interval 20.1 to 27.1
|
43.250 ng/mL
Interval 25.2 to 78.7
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, EOI+8HR
|
—
|
—
|
0.094 ng/mL
Interval 0.0 to 0.187
|
3.135 ng/mL
Interval 0.75 to 6.32
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10, EOI+24HR
|
—
|
—
|
—
|
1.015 ng/mL
Interval 0.109 to 1.92
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, EOI+5MIN
|
—
|
—
|
19.600 ng/mL
Interval 17.4 to 20.7
|
51.350 ng/mL
Interval 42.2 to 60.5
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, EOI+2HR
|
—
|
—
|
2.860 ng/mL
Interval 1.33 to 9.93
|
25.000 ng/mL
Interval 24.1 to 25.9
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, EOI+4HR
|
—
|
—
|
5.870 ng/mL
Interval 5.87 to 5.87
|
12.190 ng/mL
Interval 9.38 to 15.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, EOI+8HR
|
—
|
—
|
0.399 ng/mL
Interval 0.399 to 0.399
|
4.060 ng/mL
Interval 2.99 to 5.13
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13, EOI+24HR
|
—
|
—
|
—
|
1.227 ng/mL
Interval 0.583 to 1.87
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, EOI+5MIN
|
—
|
—
|
20.350 ng/mL
Interval 17.4 to 23.3
|
85.950 ng/mL
Interval 59.9 to 112.0
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, EOI+2HR
|
—
|
—
|
4.205 ng/mL
Interval 3.29 to 5.12
|
43.200 ng/mL
Interval 26.8 to 59.6
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19, EOI+4HR
|
—
|
—
|
0.870 ng/mL
Interval 0.87 to 0.87
|
23.600 ng/mL
Interval 11.4 to 35.8
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK73, EOI+2HR
|
—
|
—
|
2.770 ng/mL
Interval 2.77 to 2.77
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91, EOI+5MIN
|
—
|
—
|
19.900 ng/mL
Interval 19.9 to 19.9
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91, EOI+4HR
|
—
|
—
|
1.070 ng/mL
Interval 1.07 to 1.07
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91, EOI+8HR
|
—
|
—
|
0.242 ng/mL
Interval 0.242 to 0.242
|
—
|
—
|
—
|
—
|
|
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 19, 91Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=12 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1
|
—
|
—
|
41.2241 h*ng/mL
Geometric Coefficient of Variation 46.8260
|
136.9391 h*ng/mL
Geometric Coefficient of Variation 91.3047
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4
|
—
|
—
|
42.0297 h*ng/mL
Geometric Coefficient of Variation 92.4823
|
110.3856 h*ng/mL
Geometric Coefficient of Variation 83.9274
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7
|
—
|
—
|
44.0290 h*ng/mL
Geometric Coefficient of Variation 208.4637
|
217.9598 h*ng/mL
Geometric Coefficient of Variation 148.0574
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10
|
—
|
—
|
103.5186 h*ng/mL
Geometric Coefficient of Variation 400.0481
|
283.2979 h*ng/mL
Geometric Coefficient of Variation 364.4200
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13
|
—
|
—
|
—
|
189.3316 h*ng/mL
Geometric Coefficient of Variation 16.9323
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19
|
—
|
—
|
—
|
539.0039 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91
|
—
|
—
|
31.1811 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 19, 91Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=12 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1
|
—
|
—
|
23.184 ng/mL
Geometric Coefficient of Variation 13.852
|
42.961 ng/mL
Geometric Coefficient of Variation 26.296
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4
|
—
|
—
|
24.297 ng/mL
Geometric Coefficient of Variation 5.545
|
42.936 ng/mL
Geometric Coefficient of Variation 20.005
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7
|
—
|
—
|
23.179 ng/mL
Geometric Coefficient of Variation 29.068
|
38.655 ng/mL
Geometric Coefficient of Variation 20.087
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10
|
—
|
—
|
25.904 ng/mL
Geometric Coefficient of Variation 25.290
|
29.947 ng/mL
Geometric Coefficient of Variation 33.758
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13
|
—
|
—
|
—
|
50.528 ng/mL
Geometric Coefficient of Variation 25.890
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19
|
—
|
—
|
—
|
112.000 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91
|
—
|
—
|
19.900 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 4, 7, 10, 13, 19, 91Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=12 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19
|
—
|
—
|
—
|
6.5557 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK91
|
—
|
—
|
1.2513 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1
|
—
|
—
|
1.6491 Hours
Geometric Coefficient of Variation 105.7556
|
4.5289 Hours
Geometric Coefficient of Variation 65.1077
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4
|
—
|
—
|
1.7825 Hours
Geometric Coefficient of Variation 64.9647
|
5.4869 Hours
Geometric Coefficient of Variation 96.3549
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7
|
—
|
—
|
1.7101 Hours
Geometric Coefficient of Variation 121.4103
|
10.1871 Hours
Geometric Coefficient of Variation 122.2331
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10
|
—
|
—
|
1.1499 Hours
Geometric Coefficient of Variation 54.3836
|
3.9067 Hours
Geometric Coefficient of Variation 59.4336
|
—
|
—
|
—
|
|
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13
|
—
|
—
|
—
|
5.6356 Hours
Geometric Coefficient of Variation 1.5314
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and EOI+5min/2HR/ 4HR/ 8HR on crossover W 1, 4, 7, 10, 13, 19; EOI+12HR/18HR on crossover W 4; EOI+15min/ 30 min/45 min/1HR/6HR/24HR on crossover W 1, 4, 7Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+8HR
|
—
|
—
|
4.760 ng/mL
Interval 4.76 to 4.76
|
4.290 ng/mL
Interval 1.14 to 9.53
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.085 ng/mL
Interval 0.0 to 0.169
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+5MIN
|
—
|
—
|
28.900 ng/mL
Interval 28.9 to 28.9
|
39.400 ng/mL
Interval 23.6 to 65.5
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+15MIN
|
—
|
—
|
22.800 ng/mL
Interval 22.8 to 22.8
|
40.550 ng/mL
Interval 32.7 to 68.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+30MIN
|
—
|
—
|
18.600 ng/mL
Interval 18.6 to 18.6
|
31.900 ng/mL
Interval 28.8 to 38.6
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+45MIN
|
—
|
—
|
17.300 ng/mL
Interval 17.3 to 17.3
|
29.650 ng/mL
Interval 25.9 to 47.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+2HR
|
—
|
—
|
10.300 ng/mL
Interval 10.3 to 10.3
|
19.600 ng/mL
Interval 8.43 to 26.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+4HR
|
—
|
—
|
6.320 ng/mL
Interval 6.32 to 6.32
|
12.025 ng/mL
Interval 1.88 to 27.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+15MIN
|
—
|
—
|
13.200 ng/mL
Interval 13.2 to 13.2
|
45.100 ng/mL
Interval 38.6 to 55.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+30MIN
|
—
|
—
|
16.100 ng/mL
Interval 16.1 to 16.1
|
38.700 ng/mL
Interval 35.9 to 40.8
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+6HR
|
—
|
—
|
8.820 ng/mL
Interval 8.82 to 8.82
|
5.740 ng/mL
Interval 2.26 to 10.1
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+4HR
|
—
|
—
|
6.330 ng/mL
Interval 6.33 to 6.33
|
12.400 ng/mL
Interval 6.89 to 15.0
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+12HR
|
—
|
—
|
4.470 ng/mL
Interval 4.47 to 4.47
|
1.560 ng/mL
Interval 0.652 to 2.82
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+18HR
|
—
|
—
|
10.600 ng/mL
Interval 10.6 to 10.6
|
0.969 ng/mL
Interval 0.431 to 1.76
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+24HR
|
—
|
—
|
2.180 ng/mL
Interval 2.18 to 2.18
|
0.719 ng/mL
Interval 0.366 to 1.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, PREDOSE
|
—
|
—
|
3.320 ng/mL
Interval 3.32 to 3.32
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+5MIN
|
—
|
—
|
25.000 ng/mL
Interval 25.0 to 25.0
|
48.000 ng/mL
Interval 35.6 to 60.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+15MIN
|
—
|
—
|
18.700 ng/mL
Interval 18.7 to 18.7
|
40.750 ng/mL
Interval 34.1 to 47.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
0.000 ng/mL
Interval 0.0 to 0.639
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+1HR
|
—
|
—
|
14.200 ng/mL
Interval 14.2 to 14.2
|
27.000 ng/mL
Interval 24.0 to 32.6
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+6HR
|
—
|
—
|
4.780 ng/mL
Interval 4.78 to 4.78
|
8.885 ng/mL
Interval 0.74 to 14.5
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+8HR
|
—
|
—
|
6.940 ng/mL
Interval 6.94 to 6.94
|
2.835 ng/mL
Interval 0.38 to 11.2
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER, EOI+24HR
|
—
|
—
|
3.780 ng/mL
Interval 3.78 to 3.78
|
0.327 ng/mL
Interval 0.0 to 5.92
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, PREDOSE
|
—
|
—
|
8.340 ng/mL
Interval 8.34 to 8.34
|
0.000 ng/mL
Interval 0.0 to 0.155
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+5MIN
|
—
|
—
|
14.200 ng/mL
Interval 14.2 to 14.2
|
49.100 ng/mL
Interval 39.1 to 50.0
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+45MIN
|
—
|
—
|
10.500 ng/mL
Interval 10.5 to 10.5
|
38.000 ng/mL
Interval 34.7 to 38.2
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+1HR
|
—
|
—
|
10.200 ng/mL
Interval 10.2 to 10.2
|
33.700 ng/mL
Interval 30.6 to 34.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER, EOI+2HR
|
—
|
—
|
6.490 ng/mL
Interval 6.49 to 6.49
|
23.200 ng/mL
Interval 19.8 to 25.0
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+30MIN
|
—
|
—
|
20.500 ng/mL
Interval 20.5 to 20.5
|
37.300 ng/mL
Interval 29.1 to 45.5
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+45MIN
|
—
|
—
|
17.400 ng/mL
Interval 17.4 to 17.4
|
34.450 ng/mL
Interval 26.0 to 42.9
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+1HR
|
—
|
—
|
16.100 ng/mL
Interval 16.1 to 16.1
|
32.650 ng/mL
Interval 24.7 to 40.6
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+2HR
|
—
|
—
|
8.290 ng/mL
Interval 8.29 to 8.29
|
23.500 ng/mL
Interval 16.2 to 30.8
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+4HR
|
—
|
—
|
7.130 ng/mL
Interval 7.13 to 7.13
|
12.290 ng/mL
Interval 9.08 to 15.5
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+6HR
|
—
|
—
|
11.700 ng/mL
Interval 11.7 to 11.7
|
6.350 ng/mL
Interval 5.15 to 7.55
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+8HR
|
—
|
—
|
4.700 ng/mL
Interval 4.7 to 4.7
|
4.740 ng/mL
Interval 4.74 to 4.74
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER, EOI+24HR
|
—
|
—
|
3.210 ng/mL
Interval 3.21 to 3.21
|
0.822 ng/mL
Interval 0.584 to 1.06
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER, EOI+5MIN
|
—
|
—
|
10.700 ng/mL
Interval 10.7 to 10.7
|
40.000 ng/mL
Interval 33.3 to 46.7
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER, EOI+2HR
|
—
|
—
|
3.400 ng/mL
Interval 3.4 to 3.4
|
17.950 ng/mL
Interval 15.1 to 20.8
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER, EOI+4HR
|
—
|
—
|
2.300 ng/mL
Interval 2.3 to 2.3
|
9.765 ng/mL
Interval 9.13 to 10.4
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER, EOI+8HR
|
—
|
—
|
—
|
3.665 ng/mL
Interval 2.9 to 4.43
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER, PREDOSE
|
—
|
—
|
3.970 ng/mL
Interval 3.97 to 3.97
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER, EOI+5MIN
|
—
|
—
|
22.700 ng/mL
Interval 22.7 to 22.7
|
48.150 ng/mL
Interval 30.0 to 66.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER, EOI+2HR
|
—
|
—
|
9.580 ng/mL
Interval 9.58 to 9.58
|
29.650 ng/mL
Interval 28.2 to 31.1
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER, EOI+4HR
|
—
|
—
|
5.140 ng/mL
Interval 5.14 to 5.14
|
15.500 ng/mL
Interval 14.9 to 16.1
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER, EOI+8HR
|
—
|
—
|
—
|
6.070 ng/mL
Interval 6.07 to 6.07
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER, PREDOSE
|
—
|
—
|
4.110 ng/mL
Interval 4.11 to 4.11
|
0.362 ng/mL
Interval 0.0 to 0.723
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER, EOI+5MIN
|
—
|
—
|
10.700 ng/mL
Interval 10.7 to 10.7
|
56.200 ng/mL
Interval 42.7 to 69.7
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER, EOI+2HR
|
—
|
—
|
4.570 ng/mL
Interval 4.57 to 4.57
|
21.750 ng/mL
Interval 15.4 to 28.1
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER, EOI+4HR
|
—
|
—
|
—
|
9.525 ng/mL
Interval 5.75 to 13.3
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER, EOI+8HR
|
—
|
—
|
—
|
5.730 ng/mL
Interval 5.73 to 5.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 4, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER
|
—
|
—
|
914.3149 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
302.9813 h*ng/mL
Geometric Coefficient of Variation 53.3033
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER
|
—
|
—
|
1589.8051 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
979.6423 h*ng/mL
Geometric Coefficient of Variation 32.7400
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER
|
—
|
—
|
—
|
200.4303 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER
|
—
|
—
|
—
|
181.2630 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER
|
—
|
—
|
3058.1703 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
193.0653 h*ng/mL
Geometric Coefficient of Variation 68.7457
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER
|
—
|
—
|
—
|
201.3292 h*ng/mL
Geometric Coefficient of Variation 46.6743
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 4, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER
|
—
|
—
|
28.900 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
43.381 ng/mL
Geometric Coefficient of Variation 36.411
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER
|
—
|
—
|
—
|
47.379 ng/mL
Geometric Coefficient of Variation 17.834
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER
|
—
|
—
|
25.000 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
46.371 ng/mL
Geometric Coefficient of Variation 38.725
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER
|
—
|
—
|
10.700 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
39.435 ng/mL
Geometric Coefficient of Variation 24.259
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER
|
—
|
—
|
—
|
66.300 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER
|
—
|
—
|
—
|
69.700 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 4, 7, 10, 13, 19Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=1 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=4 Participants
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK1 CROSSOVER
|
—
|
—
|
1016.7767 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
15.5839 Hours
Geometric Coefficient of Variation 156.6758
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK4 CROSSOVER
|
—
|
—
|
—
|
8.2823 Hours
Geometric Coefficient of Variation 67.5066
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK7 CROSSOVER
|
—
|
—
|
8.6297 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
23.2987 Hours
Geometric Coefficient of Variation 1163.1768
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK10 CROSSOVER
|
—
|
—
|
3336.2317 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
2.2461 Hours
Geometric Coefficient of Variation 10.8792
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK13 CROSSOVER
|
—
|
—
|
—
|
2.1918 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
WEEK19 CROSSOVER
|
—
|
—
|
—
|
2.2090 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and EOI+5min/ 2HR/4HR on crossover W 1-4, 7,10,19; EOI+15min/30 min/45 min/1HR/ 6HR/ 24HR on crossover W 1,4,7;EOI+12HR/18HR on crossover W 4;EOI+8HR on crossover W 1-4,7,10Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 1.7
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+5MIN
|
—
|
—
|
15.800 ng/mL
Interval 10.0 to 47.1
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+15MIN
|
—
|
—
|
14.600 ng/mL
Interval 9.14 to 40.8
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+30MIN
|
—
|
—
|
13.200 ng/mL
Interval 9.21 to 24.3
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+45MIN
|
—
|
—
|
10.700 ng/mL
Interval 8.07 to 19.4
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+1HR
|
—
|
—
|
9.530 ng/mL
Interval 6.08 to 18.1
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+2HR
|
—
|
—
|
5.780 ng/mL
Interval 2.75 to 11.6
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+4HR
|
—
|
—
|
2.520 ng/mL
Interval 0.612 to 5.74
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+6HR
|
—
|
—
|
1.130 ng/mL
Interval 0.232 to 3.13
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+8HR
|
—
|
—
|
0.507 ng/mL
Interval 0.165 to 1.42
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.327
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER, EOI+5MIN
|
—
|
—
|
20.800 ng/mL
Interval 4.39 to 23.9
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER, EOI+2HR
|
—
|
—
|
10.040 ng/mL
Interval 2.64 to 11.5
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER, EOI+4HR
|
—
|
—
|
3.845 ng/mL
Interval 1.69 to 5.34
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER, EOI+8HR
|
—
|
—
|
0.968 ng/mL
Interval 0.871 to 1.01
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 1.02
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER, EOI+5MIN
|
—
|
—
|
17.600 ng/mL
Interval 14.9 to 21.2
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER, EOI+2HR
|
—
|
—
|
9.065 ng/mL
Interval 4.99 to 12.5
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER, EOI+4HR
|
—
|
—
|
5.125 ng/mL
Interval 1.85 to 7.77
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER, EOI+8HR
|
—
|
—
|
0.826 ng/mL
Interval 0.576 to 3.87
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.349
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+5MIN
|
—
|
—
|
15.900 ng/mL
Interval 7.73 to 31.5
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+15MIN
|
—
|
—
|
14.800 ng/mL
Interval 8.07 to 24.8
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+30MIN
|
—
|
—
|
12.750 ng/mL
Interval 6.03 to 19.1
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+45MIN
|
—
|
—
|
11.000 ng/mL
Interval 4.87 to 16.7
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+1HR
|
—
|
—
|
10.415 ng/mL
Interval 3.53 to 13.9
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+2HR
|
—
|
—
|
6.315 ng/mL
Interval 2.28 to 10.4
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+4HR
|
—
|
—
|
2.325 ng/mL
Interval 0.247 to 7.76
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+6HR
|
—
|
—
|
0.895 ng/mL
Interval 0.241 to 6.77
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+8HR
|
—
|
—
|
0.384 ng/mL
Interval 0.156 to 5.48
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+12HR
|
—
|
—
|
0.248 ng/mL
Interval 0.0 to 3.01
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+18HR
|
—
|
—
|
0.159 ng/mL
Interval 0.0 to 1.88
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER, EOI+24HR
|
—
|
—
|
0.055 ng/mL
Interval 0.0 to 1.66
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+5MIN
|
—
|
—
|
17.500 ng/mL
Interval 11.9 to 23.1
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+15MIN
|
—
|
—
|
15.100 ng/mL
Interval 10.1 to 20.1
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+30MIN
|
—
|
—
|
11.600 ng/mL
Interval 7.0 to 16.2
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+45MIN
|
—
|
—
|
9.550 ng/mL
Interval 5.4 to 13.7
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+1HR
|
—
|
—
|
7.995 ng/mL
Interval 4.09 to 11.9
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+2HR
|
—
|
—
|
4.415 ng/mL
Interval 1.61 to 7.22
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+4HR
|
—
|
—
|
1.503 ng/mL
Interval 0.295 to 2.71
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+6HR
|
—
|
—
|
0.364 ng/mL
Interval 0.111 to 0.616
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+8HR
|
—
|
—
|
0.199 ng/mL
Interval 0.0 to 0.398
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER, EOI+24HR
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER, EOI+5MIN
|
—
|
—
|
34.700 ng/mL
Interval 34.7 to 34.7
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER, EOI+2HR
|
—
|
—
|
13.900 ng/mL
Interval 13.9 to 13.9
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER, EOI+4HR
|
—
|
—
|
6.430 ng/mL
Interval 6.43 to 6.43
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER, EOI+8HR
|
—
|
—
|
1.790 ng/mL
Interval 1.79 to 1.79
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19 CROSSOVER, PREDOSE
|
—
|
—
|
0.000 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19 CROSSOVER, EOI+5MIN
|
—
|
—
|
37.000 ng/mL
Interval 37.0 to 37.0
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19 CROSSOVER, EOI+2HR
|
—
|
—
|
19.300 ng/mL
Interval 19.3 to 19.3
|
—
|
—
|
—
|
—
|
|
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK19 CROSSOVER, EOI+4HR
|
—
|
—
|
12.500 ng/mL
Interval 12.5 to 12.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 2, 3, 4, 5, 7, 10Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER
|
—
|
—
|
47.4854 h*ng/mL
Geometric Coefficient of Variation 61.4090
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER
|
—
|
—
|
119.0544 h*ng/mL
Geometric Coefficient of Variation 129.1524
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER
|
—
|
—
|
152.6791 h*ng/mL
Geometric Coefficient of Variation 93.5753
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER
|
—
|
—
|
45.7777 h*ng/mL
Geometric Coefficient of Variation 183.4279
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5 CROSSOVER
|
—
|
—
|
41.5618 h*ng/mL
Geometric Coefficient of Variation 39.4549
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER
|
—
|
—
|
23.9841 h*ng/mL
Geometric Coefficient of Variation 110.4741
|
—
|
—
|
—
|
—
|
|
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER
|
—
|
—
|
81.4712 h*ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 2, 3, 4, 5, 7, 10Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER
|
—
|
—
|
18.932 ng/mL
Geometric Coefficient of Variation 64.770
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER
|
—
|
—
|
12.504 ng/mL
Geometric Coefficient of Variation 90.216
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER
|
—
|
—
|
13.412 ng/mL
Geometric Coefficient of Variation 34.669
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER
|
—
|
—
|
15.899 ng/mL
Geometric Coefficient of Variation 60.615
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5 CROSSOVER
|
—
|
—
|
22.354 ng/mL
Geometric Coefficient of Variation 19.308
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER
|
—
|
—
|
16.580 ng/mL
Geometric Coefficient of Variation 49.604
|
—
|
—
|
—
|
—
|
|
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER
|
—
|
—
|
34.700 ng/mL
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Week 1, 2, 3, 4, 5, 7, 10Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Outcome measures
| Measure |
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q3W)
n=5 Participants
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK4 CROSSOVER
|
—
|
—
|
3.7809 Hours
Geometric Coefficient of Variation 121.5012
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK1 CROSSOVER
|
—
|
—
|
2.1460 Hours
Geometric Coefficient of Variation 66.2957
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK2 CROSSOVER
|
—
|
—
|
4.7086 Hours
Geometric Coefficient of Variation 327.1693
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK3 CROSSOVER
|
—
|
—
|
2.1828 Hours
Geometric Coefficient of Variation 54.2570
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK5 CROSSOVER
|
—
|
—
|
1.4489 Hours
Geometric Coefficient of Variation 22.9248
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK7 CROSSOVER
|
—
|
—
|
1.1078 Hours
Geometric Coefficient of Variation 38.4294
|
—
|
—
|
—
|
—
|
|
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
WEEK10 CROSSOVER
|
—
|
—
|
1.9742 Hours
Geometric Coefficient of Variation NA
GCV is not estimable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1A: GSK3745417 0.1 mg (Q3W)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Part 1A: GSK3745417 0.2 mg (Q3W)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths
Part 1A: GSK3745417 0.1 mg (Q1W)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 6 deaths
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1A: GSK3745417 0.2 mg (Q1W)
Serious events: 7 serious events
Other events: 19 other events
Deaths: 14 deaths
Part 1A: GSK3745417 0.4 mg (Q1W)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 7 deaths
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
Serious events: 2 serious events
Other events: 9 other events
Deaths: 8 deaths
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
Serious events: 4 serious events
Other events: 10 other events
Deaths: 8 deaths
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 participants at risk
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=6 participants at risk
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q1W)
n=14 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
n=2 participants at risk
Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=19 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 participants at risk
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
n=9 participants at risk
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
n=4 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
n=12 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=4 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=3 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
|
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=10 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=1 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
|
Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab
n=1 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
|
Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab
n=4 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.
|
Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=5 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Hepatobiliary disorders
Portal vein stenosis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Renal and urinary disorders
Immune-mediated cystitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
Other adverse events
| Measure |
Part 1A: GSK3745417 0.1 mg (Q3W)
n=3 participants at risk
Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q3W)
n=6 participants at risk
Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.1 mg (Q1W)
n=14 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: Japan GSK3745417 0.1 mg (Q1W)
n=2 participants at risk
Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.2 mg (Q1W)
n=19 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W)
n=10 participants at risk
Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis
n=9 participants at risk
Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab
n=4 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab
n=12 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=4 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=3 participants at risk
Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
|
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=10 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
|
Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab
n=1 participants at risk
Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
|
Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab
n=1 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
|
Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab
n=4 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.
|
Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab
n=5 participants at risk
Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
7/14 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
21.1%
4/19 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
30.0%
3/10 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
55.6%
5/9 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
2/3 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
21.1%
4/19 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
40.0%
4/10 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
40.0%
4/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
28.6%
4/14 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
28.6%
4/14 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
21.1%
4/19 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
21.4%
3/14 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
70.0%
7/10 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
75.0%
3/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
26.3%
5/19 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Application site irritation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Asthenia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Catheter site oedema
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Chest pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
3/6 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
28.6%
4/14 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
36.8%
7/19 • Number of events 24 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
10/10 • Number of events 69 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
6/9 • Number of events 19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
4/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Face oedema
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Facial pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
42.9%
6/14 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
52.6%
10/19 • Number of events 21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 15 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
77.8%
7/9 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
6/12 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
40.0%
4/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Inflammation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Malaise
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
4/6 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
28.6%
4/14 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
68.4%
13/19 • Number of events 39 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
10/10 • Number of events 56 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
6/9 • Number of events 26 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
8/12 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
75.0%
3/4 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
2/3 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
70.0%
7/10 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
26.3%
5/19 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
44.4%
4/9 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
4/12 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 15 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
75.0%
3/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
75.0%
3/4 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
30.0%
3/10 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
21.4%
3/14 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
36.8%
7/19 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 24 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
3/12 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
2/12 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
5/10 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
2/12 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal fistula
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
33.3%
1/3 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.0%
1/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Surgical and medical procedures
Pleurodesis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/19 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
15.8%
3/19 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
30.0%
3/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 62 weeks for part 1A, up to approximately 93 weeks for part 2A and up to 30.3 weeks for crossover phase.
All treated population included all the participants who received at least one dose of GSK3745417.
|
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