Trial Outcomes & Findings for Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR) (NCT NCT04630002)
NCT ID: NCT04630002
Last Updated: 2024-08-29
Results Overview
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3
Results posted on
2024-08-29
Participant Flow
This study was conducted at a single center in the United States.
A total of 54 participants (19 in Cohort 1, 19 in Cohort 2 and 16 in Cohort 3) were enrolled in the study (Safety Population: It comprised of all participants who received at least 1 dose of study medication).
Participant milestones
| Measure |
Cohort 1: GSK3640254 Then DRV/RTV Then GSK3640254 + DRV/RTV
Participants received GSK3640254 200 milligram (mg) tablets once daily on Days 1 to 7 in treatment period 1 followed by Darunavir/Ritonavir (DRV/RTV) 600/100 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 2: GSK3640254 Then ETR Then GSK3640254 + ETR
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1 followed by Etravirine (ETR) 200 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 3: GSK3640254 Then GSK3640254 + DRV/RTV + ETR
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1. Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in treatment period 2.
|
|---|---|---|---|
|
Cohort 1:Washout Period (Days 8 to 11)
COMPLETED
|
19
|
0
|
0
|
|
Cohort 1:Washout Period (Days 8 to 11)
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort1:Treatment Period2(Days 12 to 21)
STARTED
|
19
|
0
|
0
|
|
Cohort1:Treatment Period2(Days 12 to 21)
COMPLETED
|
17
|
0
|
0
|
|
Cohort 1:Treatment Period 1(Days 1 to 7)
STARTED
|
19
|
0
|
0
|
|
Cohort 1:Treatment Period 1(Days 1 to 7)
COMPLETED
|
19
|
0
|
0
|
|
Cohort 1:Treatment Period 1(Days 1 to 7)
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 1:Washout Period (Days 8 to 11)
STARTED
|
19
|
0
|
0
|
|
Cohort1:Treatment Period2(Days 12 to 21)
NOT COMPLETED
|
2
|
0
|
0
|
|
Cohort1:Treatment Period3(Days 22 to 31)
STARTED
|
17
|
0
|
0
|
|
Cohort1:Treatment Period3(Days 22 to 31)
COMPLETED
|
15
|
0
|
0
|
|
Cohort1:Treatment Period3(Days 22 to 31)
NOT COMPLETED
|
2
|
0
|
0
|
|
Cohort 2:Treatment Period 1(Days 1 to 7)
STARTED
|
0
|
19
|
0
|
|
Cohort 2:Treatment Period 1(Days 1 to 7)
COMPLETED
|
0
|
19
|
0
|
|
Cohort 2:Treatment Period 1(Days 1 to 7)
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 2: Washout Period (Days 8 to 11)
STARTED
|
0
|
19
|
0
|
|
Cohort 2: Washout Period (Days 8 to 11)
COMPLETED
|
0
|
19
|
0
|
|
Cohort 2: Washout Period (Days 8 to 11)
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort2:Treatment Period2(Days 12 to 21)
STARTED
|
0
|
19
|
0
|
|
Cohort2:Treatment Period2(Days 12 to 21)
COMPLETED
|
0
|
17
|
0
|
|
Cohort2:Treatment Period2(Days 12 to 21)
NOT COMPLETED
|
0
|
2
|
0
|
|
Cohort2:Treatment Period3(Days 22 to 31)
STARTED
|
0
|
17
|
0
|
|
Cohort2:Treatment Period3(Days 22 to 31)
COMPLETED
|
0
|
14
|
0
|
|
Cohort2:Treatment Period3(Days 22 to 31)
NOT COMPLETED
|
0
|
3
|
0
|
|
Cohort 3:Treatment Period 1(Days 1 to 7)
STARTED
|
0
|
0
|
16
|
|
Cohort 3:Treatment Period 1(Days 1 to 7)
COMPLETED
|
0
|
0
|
16
|
|
Cohort 3:Treatment Period 1(Days 1 to 7)
NOT COMPLETED
|
0
|
0
|
0
|
|
Cohort 3:Treatment Period2(Days 8 to 21)
STARTED
|
0
|
0
|
16
|
|
Cohort 3:Treatment Period2(Days 8 to 21)
COMPLETED
|
0
|
0
|
14
|
|
Cohort 3:Treatment Period2(Days 8 to 21)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: GSK3640254 Then DRV/RTV Then GSK3640254 + DRV/RTV
Participants received GSK3640254 200 milligram (mg) tablets once daily on Days 1 to 7 in treatment period 1 followed by Darunavir/Ritonavir (DRV/RTV) 600/100 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 2: GSK3640254 Then ETR Then GSK3640254 + ETR
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1 followed by Etravirine (ETR) 200 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 3: GSK3640254 Then GSK3640254 + DRV/RTV + ETR
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1. Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in treatment period 2.
|
|---|---|---|---|
|
Cohort1:Treatment Period2(Days 12 to 21)
Physician Decision
|
2
|
0
|
0
|
|
Cohort1:Treatment Period3(Days 22 to 31)
Physician Decision
|
1
|
0
|
0
|
|
Cohort1:Treatment Period3(Days 22 to 31)
Adverse Event
|
1
|
0
|
0
|
|
Cohort2:Treatment Period2(Days 12 to 21)
Physician Decision
|
0
|
2
|
0
|
|
Cohort2:Treatment Period3(Days 22 to 31)
Physician Decision
|
0
|
2
|
0
|
|
Cohort2:Treatment Period3(Days 22 to 31)
Adverse Event
|
0
|
1
|
0
|
|
Cohort 3:Treatment Period2(Days 8 to 21)
Physician Decision
|
0
|
0
|
1
|
|
Cohort 3:Treatment Period2(Days 8 to 21)
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Baseline characteristics by cohort
| Measure |
Cohort 1: GSK3640254 Then DRV/RTV Then GSK3640254 + DRV/RTV
n=19 Participants
Participants received GSK3640254 200 milligram (mg) tablets once daily on Days 1 to 7 in treatment period 1 followed by Darunavir/Ritonavir (DRV/RTV) 600/100 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 2: GSK3640254 Then ETR Then GSK3640254 + ETR
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1 followed by Etravirine (ETR) 200 mg tablets twice daily on Days 12 to 21 in treatment period 2. There was a washout period on Days 8 to 11 between treatment periods 1 and 2. Participants also received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in treatment period 3.
|
Cohort 3: GSK3640254 Then GSK3640254 + DRV/RTV + ETR
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in treatment period 1. Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in treatment period 2.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 5.98 • n=5 Participants
|
31.2 Years
STANDARD_DEVIATION 6.18 • n=7 Participants
|
32.0 Years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
32.5 Years
STANDARD_DEVIATION 7.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
ASIAN-CENTRAL/SOUTH ASIAN HERITAGE (H)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
ASIAN-JAPANESE H/EAST ASIAN H/SOUTH EAST ASIAN H
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
BLACK (BLA) OR AFRICAN AMERICAN (AFR AME)
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
WHITE-ARABIC NORTH AFR WHITE H
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
WHITE-CAUCASIAN EUROPEAN WHITE H
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
AME INDIAN OR ALASKA NATIVE &BLA OR AFR AMR &WHITE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population comprised of all participants who underwent plasma pharmacokinetic sampling and had at least 1 evaluable Pharmacokinetic parameter estimated. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254
|
30.70 Hours*micrograms per milliliter
Geometric Coefficient of Variation 33.6
|
27.03 Hours*micrograms per milliliter
Geometric Coefficient of Variation 33.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Maximum Observed Concentration (Cmax) of GSK3640254
|
1.863 Micrograms per milliliter
Geometric Coefficient of Variation 41.0
|
1.752 Micrograms per milliliter
Geometric Coefficient of Variation 39.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: AUC(0-tau) of DRV
|
53.37 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.1
|
57.47 Hours*micrograms per milliliter
Geometric Coefficient of Variation 25.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Cmax of DRV
|
7.268 Micrograms per milliliter
Geometric Coefficient of Variation 21.7
|
7.037 Micrograms per milliliter
Geometric Coefficient of Variation 24.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: AUC(0-tau) of RTV
|
7.790 Hours* micrograms per milliliter
Geometric Coefficient of Variation 45.9
|
7.303 Hours* micrograms per milliliter
Geometric Coefficient of Variation 48.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Cmax of RTV
|
1.306 Micrograms per milliliter
Geometric Coefficient of Variation 36.6
|
1.178 Micrograms per milliliter
Geometric Coefficient of Variation 43.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: AUC(0-tau) of GSK3640254
|
14.73 Hours*micrograms per milliliter
Geometric Coefficient of Variation 26.5
|
27.86 Hours*micrograms per milliliter
Geometric Coefficient of Variation 27.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Cmax of GSK3640254
|
1.136 Micrograms per milliliter
Geometric Coefficient of Variation 28.5
|
1.889 Micrograms per milliliter
Geometric Coefficient of Variation 38.2
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: AUC(0-tau) of ETR
|
9.791 Hours*micrograms per milliliter
Geometric Coefficient of Variation 32.8
|
8.340 Hours*micrograms per milliliter
Geometric Coefficient of Variation 36.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Cmax of ETR
|
1.102 Micrograms per milliliter
Geometric Coefficient of Variation 33.0
|
0.9749 Micrograms per milliliter
Geometric Coefficient of Variation 35.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=14 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: AUC(0-tau) of GSK3640254
|
22.78 Hours*micrograms per milliliter
Geometric Coefficient of Variation 34.3
|
24.99 Hours*micrograms per milliliter
Geometric Coefficient of Variation 34.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 2Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=14 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Cmax of GSK3640254
|
1.383 Micrograms per milliliter
Geometric Coefficient of Variation 32.5
|
1.578 Micrograms per milliliter
Geometric Coefficient of Variation 34.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of DRV
|
2.637 Micrograms per milliliter
Geometric Coefficient of Variation 36.5
|
2.957 Micrograms per milliliter
Geometric Coefficient of Variation 37.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DRV
|
3.000 Hours
Interval 1.57 to 4.0
|
3.000 Hours
Interval 1.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Ctau of RTV
|
0.3314 Micrograms per milliliter
Geometric Coefficient of Variation 91.1
|
0.3194 Micrograms per milliliter
Geometric Coefficient of Variation 77.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Tmax of RTV
|
4.000 Hours
Interval 2.0 to 4.0
|
4.000 Hours
Interval 2.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Ctau of GSK3640254
|
0.9530 Micrograms per milliliter
Geometric Coefficient of Variation 35.2
|
0.8152 Micrograms per milliliter
Geometric Coefficient of Variation 34.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Tmax of GSK3640254
|
4.000 Hours
Interval 1.5 to 11.93
|
4.000 Hours
Interval 1.5 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Ctau of ETR
|
0.5837 Micrograms per milliliter
Geometric Coefficient of Variation 33.1
|
0.4705 Micrograms per milliliter
Geometric Coefficient of Variation 37.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours post-dose in Treatment Periods 2 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Tmax of ETR
|
4.000 Hours
Interval 2.0 to 8.0
|
3.500 Hours
Interval 2.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Ctau of GSK3640254
|
0.3901 Micrograms per milliliter
Geometric Coefficient of Variation 50.2
|
0.7706 Micrograms per milliliter
Geometric Coefficient of Variation 36.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5 Hours, 1 Hour, 1.5 Hours, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 16 Hours, 24 Hours post-dose in Treatment Periods 1 and 3Population: Pharmacokinetic Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Tmax of GSK3640254
|
3.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety Population comprised of all participants who received at least 1 dose of study medication.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
non-SAE
|
4 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Day 36Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With SAEs and Non-SAEs
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With SAEs and Non-SAEs
non-SAE
|
4 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Day 26Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With SAEs and Non-SAEs
SAE
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With SAEs and Non-SAEs
non-SAE
|
8 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths
AEs leading to discontinuations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With AEs Leading to Discontinuations and Deaths
AES leading to deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 36Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths
AEs leading to discontinuations
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort 2: Number of Participants With AEs Leading to Discontinuations and Deaths
AES leading to deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 26Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs leading to discontinuations and deaths were reported.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths
AEs leading to discontinuations
|
1 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With AEs Leading to Discontinuations and Deaths
AES leading to deaths
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 35Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 Grams per deciliter (g/dL) (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells per cubic millimeter (cells/mm\^3),Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells per liter (cells/L),Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 36Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 26Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of hematology parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Hemoglobin Low, Grade 3: 7.0 to \<9.0 g/dL (males) and 6.5 to \<8.5 g/dL (females),Grade 4: \<7.0 g/dL (males) and \<6.5 g/dL (females); Leukocytes Low, Grade 3: 1000 to 1499 cells/mm\^3,Grade 4: \<1000 cells/mm\^3; Lymphocytes Low, Grade 3: 350 to \<500 cells/L,Grade 4: \<350 cells/L; Neutrophils Low, Grade 3: 400 to 599 cells/mm\^3, Grade 4: \<400 cells/mm\^3; Platelets Low, Grade 3: 25,000 to \<50,000 cells/mm\^3, Grade 4: \<25,000 cells/mm\^3. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hemoglobin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Leukocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Lymphocytes, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Neutrophils, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Platelets, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 35Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 times (×) Upper Limit Normal (ULN), Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 grams per deciliter (g/dL), Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 35Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 milligrams/deciliter (mg/dL), Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 Milliequivalents per liter (mEq/L),Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 35Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 36Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 36Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 36Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 26Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Alanine Aminotransferase High; Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Albumin Low, Grade 3: \<2.0 g/dL, Grade 4: Not Applicable; Alkaline Phosphatase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Amylase High, Grade 3: 3.0 to \<5.0 × ULN, Grade 4: \>=5.0 × ULN; Aspartate Aminotransferase High, Grade 3: 5.0 to \<10.0 × ULN, Grade 4: \>=10.0 × ULN; Bilirubin High, Grade 3: 2.6 to\<5.0 × ULN, Grade 4: \>=5.0 × ULN and Direct Bilirubin High, Grade 3: \>ULN with other signs and symptoms of hepatotoxicity, Grade 4: \>ULN with life-threatening consequences. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Aspartate Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Direct Bilirubin, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alanine Aminotransferase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Albumin, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Alkaline Phosphatase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Bilirubin and Direct Bilirubin
Amylase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 26Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Calcium High, Grade 3: 12.5 to \<13.5 mg/dL, Grade 4: \>=13.5 mg/dL; Calcium Low, Grade 3: 6.1 to \<7.0 mg/dL, Grade 4: \<6.1 mg/dL; Creatine Kinase High, Grade 3: 10 to \<20 × ULN, Grade 4: \>=20 × ULN; Creatinine High, Grade 3: \>1.8 to \<3.5 ULN, Grade 4: \>=3.5 × ULN; Phosphate Low, Grade 3: 1.0 to \<1.4 mg/dL, Grade 4: \<1.0 mg/dL; Potassium High, Grade 3: 6.5 to \<7.0 mEq/L,Grade 4: \>=7.0 mEq/L; Potassium Low, Grade 3: 2.0 to \<2.5 mEq/L, Grade 4: \<2.00 mEq/L; Sodium High, Grade 3: 154 to \<160 mEq/L, Grade 4:\>=160 mEq/L; Sodium Low, Grade 3: 121 to \<125 mEq/L, Grade 4:\<=120 mEq/L. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Calcium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatine Kinase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Creatinine, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Phosphate, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Potassium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Calcium, Creatine Kinase, Creatinine, Phosphate, Potassium and Sodium
Sodium, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 26Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Blood samples were collected for analysis of clinical chemistry parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Glucose High, Grade 3: \>250 to 500 mg/dL, Grade 4: \>=500 mg/dL, Glucose Low, Grade 3: 30 to\<40 mg/dL, Grade 4:\<30 mg/dL; Triglycerides High, Grade 3: \>500 to \<1.000 mg/dL, Grade 4:\>1000 mg/dL; Lipase High, Grade 3: 3.0 to \<5.0×ULN, Grade 4:\>=5.0×ULN; Urate High, Grade 3: 12.0 to \<15.0 mEq/L, Grade 4:\>=15.0 mEq/L; Cholesterol High, Grade 3: \>=300 mg/dL, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, Low, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Triglycerides, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Lipase, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Urate, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters: Glucose, Triglycerides, Lipase, Urate and Cholesterol
Cholesterol, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 35Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with Red Blood Cells (RBC) casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 36Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day-1) and up to Day 26Population: Safety Population. Only those participants with increase to grade 3 and increase to grade 4 were presented.
Urine samples were collected for urinalysis parameters. Laboratory abnormalities were graded according to DAIDS grading table Version 2.1. For Erythrocytes High, Grade 3: Gross, with or without clots OR with RBC casts OR intervention indicated, Grade 4: Life-threatening consequences; Glucose High, Grade 3: \>2+ (proportionate concentration by dipstick test) or \>500 mg, Grade 4: \>500 mg; Protein High, Grade 3: 3+ (proportionate concentration by dipstick test) or higher, Grade 4: Not Applicable. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in DAIDS grade relative to Baseline grade.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Erythrocytes, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Glucose, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Urinalysis Parameters
Protein, High, Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety Population
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 millimeters of mercury (mmHg), for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria
SBP
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria
DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) Criteria
Pulse rate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 36Population: Safety Population
Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria
DBP
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort 2: Number of Participants With Vital Sign Values of PCI Criteria
Pulse rate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 26Population: Safety Population
Vital signs including SBP, DBP and pulse rate were measured in a supine position after atleast 5 minutes of rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>140 mmHg, for DBP \<45 or \>90 mmHg, for pulse rate \<40 or \>100 beats per minute. The number of participants with vital signs of PCI were presented.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria
SBP
|
0 Participants
|
1 Participants
|
—
|
|
Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria
DBP
|
0 Participants
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Vital Sign Values of PCI Criteria
Pulse rate
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 35 in Treatment Period 3Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
2 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
4 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
6 Hours; Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Day 7
|
—
|
0 Participants
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Day 11
|
—
|
0 Participants
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
2 Hours, Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
4 Hours, Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
6 Hours; Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Day 21
|
0 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
2 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
4 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
6 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Day 26
|
—
|
—
|
0 Participants
|
|
Cohort 1: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Day 35
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (2,4,6 Hours), Day 7 and Day 11 in Treatment Period 1; Day 12 (2,4,6 Hours), Day 21 in Treatment Period 2; Day 22 (2,4,6 Hours), Day 26 and Day 36 in Treatment Period 3Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=19 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours; Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 7
|
—
|
0 Participants
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 11
|
—
|
0 Participants
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours, Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours, Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours; Day 12
|
0 Participants
|
—
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 21
|
0 Participants
|
—
|
—
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours; Day 22
|
—
|
—
|
0 Participants
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 26
|
—
|
—
|
0 Participants
|
|
Cohort 2: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 36
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (2,4,6 Hours) in Treatment Period 1; Day 8 (2,4,6 Hours), Day 9 (2,4,6 Hours), Day 26 in Treatment Period 2Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
A 12-lead ECG was recorded with the participant in a supine position using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal ECG findings were reported. Data has been presented for the participants with respect to the actual treatment received in respective treatment periods.
Outcome measures
| Measure |
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 Participants
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
Cohort 1: GSK3640254 200 mg
n=16 Participants
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
|---|---|---|---|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours, Day 1
|
—
|
0 Participants
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours, Day 8
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours, Day 8
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours, Day 8
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
2 Hours; Day 9
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
4 Hours; Day 9
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
6 Hours; Day 9
|
0 Participants
|
—
|
—
|
|
Cohort 3: Number of Participants With Clinically Significant Abnormal ECG Findings
Day 26
|
0 Participants
|
—
|
—
|
Adverse Events
Cohort 1: GSK3640254 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1: DRV/RTV 600/100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: GSK3640254 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: ETR 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: GSK3640254 200 mg + ETR 200 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: GSK3640254 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: GSK3640254 200 mg
n=19 participants at risk
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 1 of the study.
|
Cohort 1: DRV/RTV 600/100 mg
n=16 participants at risk
Participants received DRV/RTV 600/100 mg tablets twice daily on Days 12 to 21 in Treatment Period 2 of Cohort 1 of the study.
|
Cohort 1: GSK3640254 200 mg + DRV/RTV 600/100 mg
n=15 participants at risk
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 1 of the study.
|
Cohort 2: GSK3640254 200 mg
n=19 participants at risk
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment period 1 of Cohort 2 of the study.
|
Cohort 2: ETR 200 mg
n=16 participants at risk
Participants received ETR 200 mg tablets twice daily on Days 12 to 21 Treatment Period 2 of Cohort 2 of the study.
|
Cohort 2: GSK3640254 200 mg + ETR 200 mg
n=16 participants at risk
Participants received GSK3640254 200 mg tablets once daily along with ETR 200 mg tablets twice daily on Days 22 to 31 in Treatment Period 3 of Cohort 2 of the study.
|
Cohort 3: GSK3640254 200 mg
n=16 participants at risk
Participants received GSK3640254 200 mg tablets once daily on Days 1 to 7 in Treatment Period 1 of Cohort 3 of the study.
|
Cohort 3: GSK3640254 200 mg+ DRV/RTV 600/100 mg+ ETR 200 mg
n=15 participants at risk
Participants received GSK3640254 200 mg tablets once daily along with DRV/RTV 600/100 mg tablets twice daily and ETR 200 mg tablets twice daily on Days 8 to 21 in Treatment Period 2 of Cohort 3 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
20.0%
3/15 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
13.3%
2/15 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
20.0%
3/15 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Eye disorders
Scleral hyperaemia
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
20.0%
3/15 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
General disorders
Application site irritation
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Investigations
Heart rate increased
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
0.00%
0/16 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Day 35 during Cohort 1; up to Day 36 during Cohort 2; up to Day 26 during Cohort 3
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all participants who received at least 1 dose of study medication. AEs were presented cohort-wise and treatment-wise.
|
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