Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody (NCT NCT03525678)

Last Updated: 2025-09-03

Results Overview

ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

221 participants

Primary outcome timeframe

Up to 48 weeks

Results posted on

2025-09-03

Participant Flow

This was an open-label, randomized, multicenter study to evaluate the efficacy and safety of belantamab mafodotin monotherapy at a dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg, given intravenously (IV) in participants with relapsed/refractory multiple myeloma (RRMM).

A total of 221 participants were enrolled in this study. The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants benefiting from drug continued to receive study drug until discontinuation or withdrawal from study.

Participant milestones

Participant milestones
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.	PACT Phase: GSK2857916 2.5 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.	PACT Phase: GSK2857916 3.4 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks up to approximately 101 weeks. Frozen liquid was diluted with 0.9 percent saline.
Main Study (Day 1 to 186 Weeks) STARTED	97	99	25	0	0
Main Study (Day 1 to 186 Weeks) Received Study Treatment	95	99	24	0	0
Main Study (Day 1 to 186 Weeks) COMPLETED	0	0	0	0	0
Main Study (Day 1 to 186 Weeks) NOT COMPLETED	97	99	25	0	0
PACT Phase (From 186 Weeks to 325 Weeks) STARTED	0	0	0	1	2
PACT Phase (From 186 Weeks to 325 Weeks) COMPLETED	0	0	0	1	2
PACT Phase (From 186 Weeks to 325 Weeks) NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Main Study (Day 1 to 186 Weeks) Withdrawal by Subject	8	2	2
Main Study (Day 1 to 186 Weeks) Physician Decision	2	4	0
Main Study (Day 1 to 186 Weeks) Lost to Follow-up	2	1	2
Main Study (Day 1 to 186 Weeks) Death	70	80	16
Main Study (Day 1 to 186 Weeks) other reasons	14	10	5
Main Study (Day 1 to 186 Weeks) Transitioned to PACT phase	1	2	0

Baseline Characteristics

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.	Total n=221 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 10.01 • n=5 Participants	66.0 Years STANDARD_DEVIATION 9.09 • n=7 Participants	67.2 Years STANDARD_DEVIATION 10.78 • n=5 Participants	65.3 Years STANDARD_DEVIATION 10.01 • n=4 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	43 Participants n=7 Participants	11 Participants n=5 Participants	100 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	56 Participants n=7 Participants	14 Participants n=5 Participants	121 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	30 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	72 Participants n=5 Participants	83 Participants n=7 Participants	21 Participants n=5 Participants	176 Participants n=4 Participants
Race/Ethnicity, Customized Mixed Asian Race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Mixed White Race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Missing	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 48 weeks

Population: Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)	31 Percentage of Participants Interval 20.8 to 42.6	34 Percentage of Participants Interval 23.9 to 46.0	48 Percentage of Participants Interval 25.5 to 71.1

PRIMARY outcome

Timeframe: Up to 48 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.

ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=64 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=66 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Response Rate by Independent Review Committee (Efficacy Population)	30 Percentage of Participants Interval 18.9 to 42.4	30 Percentage of Participants Interval 19.6 to 42.9	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)	33 Percentage of Participants Interval 23.8 to 43.3	32 Percentage of Participants Interval 23.3 to 42.5	52 Percentage of Participants Interval 31.3 to 72.2

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=64 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=66 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Response Rate by Investigator Assessment (Efficacy Population)	33 Percentage of Participants Interval 21.6 to 45.7	26 Percentage of Participants Interval 15.8 to 38.0	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)	35 Percentage of Participants Interval 25.6 to 45.4	38 Percentage of Participants Interval 28.8 to 48.7	60 Percentage of Participants Interval 38.7 to 78.9

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.

CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=64 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=66 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Clinical Benefit Rate by Investigator Assessment (Efficacy Population)	34 Percentage of Participants Interval 22.9 to 47.3	35 Percentage of Participants Interval 23.5 to 47.6	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)	36 Percentage of Participants Interval 26.6 to 46.5	40 Percentage of Participants Interval 30.7 to 50.7	56 Percentage of Participants Interval 34.9 to 75.6

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=64 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=66 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Clinical Benefit Rate by Independent Review Committee (Efficacy Population)	34 Percentage of Participants Interval 22.9 to 47.3	38 Percentage of Participants Interval 26.2 to 50.7	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.

DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=32 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=32 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=13 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)	12.4 Months Interval 4.2 to 21.4	12.6 Months Interval 5.6 to 22.8	5.3 Months Interval 2.8 to 9.0

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis.

DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=21 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=17 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Duration of Response by Investigator Assessment (Efficacy Population)	6.9 Months Interval 4.2 to 20.8	15.9 Months Interval 12.6 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=31 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=35 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=13 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Duration of Response by Independent Review Committee (Full Analysis Population)	12.5 Months Interval 4.2 to 19.4	6.2 Months Interval 4.2 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	9.0 Months Interval 3.4 to 10.4

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=20 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=20 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Duration of Response by Independent Review Committee (Efficacy Population)	11.0 Months Interval 4.0 to 19.4	15.9 Months Interval 4.2 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population. Only responders (confirmed PR or better) by investigator assessment were included in this analysis

Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=32 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=32 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=13 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Response by Investigator Assessment (Full Analysis Population)	1.5 Months Interval 0.8 to 2.5	1.5 Months Interval 0.9 to 3.0	0.9 Months Interval 0.8 to 1.0

SECONDARY outcome

Timeframe: Up to 186 weeks

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=21 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=17 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Response by Investigator Assessment (Efficacy Population)	1.4 Months Interval 0.8 to 2.8	1.5 Months Interval 1.4 to 2.8	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=31 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=35 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=13 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Response by Independent Review Committee (Full Analysis Population)	1.5 Months Interval 0.8 to 2.2	1.4 Months Interval 0.8 to 2.8	0.9 Months Interval 0.8 to 2.3

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=20 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=20 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Response by Independent Review Committee (Efficacy Population)	1.5 Months Interval 0.8 to 2.5	1.4 Months Interval 1.1 to 1.9	—

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Progression Free Survival by Investigator Assessment	2.2 Months Interval 0.8 to 7.7	3.2 Months Interval 1.0 to 9.8	3.6 Months Interval 1.5 to 8.7

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Progression Free Survival by Independent Review Committee	2.8 Months Interval 0.9 to 9.7	3.9 Months Interval 0.8 to 9.0	5.7 Months Interval 2.2 to 9.7

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Progression by Investigator Assessment	2.2 Months Interval 0.8 to 7.7	3.9 Months Interval 1.0 to 11.9	3.6 Months Interval 1.5 to 9.7

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Time to Progression by Independent Review Committee	2.9 Months Interval 0.9 to 9.7	4.9 Months Interval 0.8 to 11.1	5.7 Months Interval 2.2 to 9.7

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Analysis Population

Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=25 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Survival	15.3 Months Interval 4.8 to 36.4	14.0 Months Interval 6.2 to 26.6	24.5 Months Interval 7.7 to \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Following parameters were assessed:basophils,eosinophils,hematocrit,mean corpuscular hemoglobin (MCH),MCH concentration,MC volume,monocyte,erythrocytes, reticulocytes.Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range\[LNR\]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Basophils, decrease to low, n=94,96,23	2 Participants	7 Participants	0 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Basophils, change to normal or NC, n=94,96,23	87 Participants	85 Participants	19 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Basophils, increase to high, n=94,96,23	5 Participants	5 Participants	4 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Eosinophils, decrease to low, n=95,97,23	14 Participants	13 Participants	0 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Eosinophils, change to normal or NC, n=95,97,23	71 Participants	78 Participants	16 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Eosinophils, increase to high, n=95,97,23	10 Participants	8 Participants	7 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Hematocrit, decrease to low, n=95,97,24	10 Participants	3 Participants	1 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Hematocrit, change to normal or NC, n=95,97,24	84 Participants	94 Participants	23 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Hematocrit, increase to high, n=95,97,24	3 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21	14 Participants	17 Participants	5 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21	79 Participants	68 Participants	14 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Hemoglobin, increase to high, n=95,95,21	2 Participants	12 Participants	2 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range MCH Concentration, decrease to low, n=94,96,21	20 Participants	28 Participants	6 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range MCH Concentration, change to normal or NC, n=94,96,21	70 Participants	66 Participants	14 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range MCH Concentration, increase to high, n=94,96,21	5 Participants	2 Participants	1 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Volume, decrease to low, n=95,97,24	12 Participants	15 Participants	4 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Volume, change to normal or NC, n=95,97,24	77 Participants	73 Participants	18 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Mean Corpuscular Volume, increase to high, n=95,97,24	7 Participants	10 Participants	3 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Monocytes, decrease to low, n=95,97,24	6 Participants	10 Participants	1 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Monocytes, change to normal or NC, n=95,97,24	62 Participants	50 Participants	12 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Monocytes, increase to high, n=95,97,24	28 Participants	45 Participants	12 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Erythrocytes, decrease to low, n=95,97,24	4 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Erythrocytes, change to normal or NC, n=95,97,24	91 Participants	95 Participants	21 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Erythrocytes, increase to high, n=95,97,24	2 Participants	1 Participants	3 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Reticulocytes, decrease to low, n=73,65,19	11 Participants	15 Participants	7 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Reticulocytes, change to normal or NC, n=73,65,19	49 Participants	33 Participants	3 Participants
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range Reticulocytes, increase to high, n=73,65,19	16 Participants	21 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=97 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Grade Change From Baseline in Hematology Parameters Leuko, Leuko decreased, increase to Grade 4	3 Participants	3 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Hb, Hb increased, increase to Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Hb, Hb increased, increase to Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Hb, Anemia, increase to Grade 3	19 Participants	30 Participants	5 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Hb, Anemia, increase to Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Lymph, Lymph count increased, increase to Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Lymph, Lymph count increased, increase to Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Lymph, Lymph count decreased, increase to Grade 3	16 Participants	24 Participants	6 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Lymph, Lymph count decreased, increase to Grade 4	5 Participants	5 Participants	2 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Neutro, increase to Grade 3	4 Participants	10 Participants	2 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Neutro, increase to Grade 4	6 Participants	3 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters PC, increase to Grade 3	9 Participants	11 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters PC, increase to Grade 4	13 Participants	25 Participants	2 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Leuko, Leukocytosis, increase to Grade 3	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Leuko, Leukocytosis, increase to Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Hematology Parameters Leuko, Leuko decreased, increase to Grade 3	5 Participants	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein,Urea enzymatic colorimetry.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Bicarbonate, decrease to low, n=90,93,24	12 Participants	22 Participants	4 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Bicarbonate, change to normal or NC, n=90,93,24	67 Participants	59 Participants	16 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Bicarbonate, increase to high, n=90,93,24	12 Participants	16 Participants	4 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Direct Bilirubin, decrease to low, n=70,72,21	0 Participants	2 Participants	0 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Direct Bilirubin, change to normal or NC, n=70,72,21	60 Participants	60 Participants	20 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Direct Bilirubin, increase to high, n=70,72,21	10 Participants	10 Participants	1 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Calcium, decrease to low, n=95,98,24	26 Participants	28 Participants	8 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Calcium, change to normal or NC, n=95,98,24	49 Participants	48 Participants	9 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Calcium, increase to high, n=95,98,24	29 Participants	27 Participants	9 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Chloride, decrease to low, n=94,97,24	17 Participants	14 Participants	2 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Chloride, change to normal or NC, n=94,97,24	63 Participants	63 Participants	20 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Chloride, increase to high, n=94,97,24	14 Participants	24 Participants	2 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range LDH, decrease to low, n=92,98,23	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range LDH, change to normal or NC, n=92,98,23	46 Participants	51 Participants	12 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range LDH, increase to high, n=92,98,23	45 Participants	47 Participants	11 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Protein, decrease to low, n=94,98,24	32 Participants	32 Participants	8 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Protein, change to normal or NC, n=94,98,24	49 Participants	58 Participants	14 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Protein, increase to high, n=94,98,24	17 Participants	11 Participants	2 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Urea enzymatic colorimetry , decrease to low, n=90,93,24	10 Participants	13 Participants	0 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Urea enzymatic colorimetry, change to normal or NC, n=90,93,24	66 Participants	56 Participants	16 Participants
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range Urea enzymatic colorimetry, increase to high, n=90,93,24	15 Participants	26 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Blood samples were collected for analysis of:glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil),creatinine kinase (CK),creatinine, gamma glutamyl transferase (GGT),potassium (Pot), magnesium (Mg),sodium (Sod), phosphate (Ph) urate \& estimated glomerular filtration rate (eGFR). Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Grading was according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences.Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented.Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Gl, Hyper, increase to Grade 3, n=94,95,24	3 Participants	5 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Gl, Hyper, increase to Grade 4, n=94,95,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Gl, Hypo, increase to Grade 3, n=94,95,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Gl, Hypo, increase to Grade 4, n=94,95,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Albumin, increase to Grade 3, n=94,98,24	4 Participants	7 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Albumin, increase to Grade 4, n=94,98,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters ALP, increase to Grade 3, n=93,97,24	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters ALP, increase to Grade 4, n=93,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters ALT, increase to Grade 3, n=93,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters ALT, increase to Grade 4, n=93,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters AST, increase to Grade 3, n=93,96,24	3 Participants	7 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters AST, increase to Grade 4, n=93,96,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters T.Bil, increase to Grade 3, n=92,97,23	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters T.Bil, increase to Grade 4, n=92,97,23	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters CK, increase to Grade 3, n= 87,91,24	1 Participants	0 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters CK, increase to Grade 4, n= 87,91,24	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Creatinine, increase to Grade 3, n= 95,97,24	4 Participants	3 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Creatinine, increase to Grade 4, n= 95,97,24	1 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters GGT, increase to Grade 3, n= 91,95,24	5 Participants	11 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters GGT, increase to Grade 4, n= 91,95,24	1 Participants	1 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Pot, Hyper,increase to Grade 3, n= 95,97,24	0 Participants	1 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Pot, Hyper,increase to Grade 4, n= 95,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Pot, Hypo, increase to Grade 3, n= 95,97,24	0 Participants	4 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Pot, Hypo, increase to Grade 4, n= 95,97,24	2 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Mg, Hyper, increase to Grade 3, n= 91,96,24	3 Participants	1 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Mg, Hyper, increase to Grade 4, n= 91,96,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Mg, Hypo, increase to Grade 3, n= 91,96,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Mg, Hypo, increase to Grade 4, n= 91,96,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Phosphate, increase to Grade 3, n= 90,93,24	4 Participants	8 Participants	2 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Phosphate, increase to Grade 4, n= 90,93,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Sod, Hyper, increase to Grade 3, n= 95,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Sod, Hyper, increase to Grade 4, n= 95,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Sod, Hypo, increase to Grade 3, n= 95,97,24	2 Participants	6 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Sod, Hypo, increase to Grade 4, n= 95,97,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Urate, increase to Grade 3, n= 93,96,24	0 Participants	0 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters Urate, increase to Grade 4, n= 93,96,24	3 Participants	5 Participants	1 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters eGFR, increase to Grade 3, n= 84,85,23	8 Participants	11 Participants	0 Participants
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters eGFR, increase to Grade 4, n= 84,85,23	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Safety Population. This analysis was planned, but data was not collected and captured in the database.

Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to \<60 beats per minute \[bpm\]', 'increase to \>100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to \>100 bpm to increase to \>100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<60 bpm' and 'increased to \>100 bpm' during post Baseline. Data for worst-case post Baseline is presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Change From Baseline in Pulse Rate Decrease to <60	14 Participants	17 Participants	6 Participants
Number of Participants With Change From Baseline in Pulse Rate Change to normal or no change	57 Participants	55 Participants	15 Participants
Number of Participants With Change From Baseline in Pulse Rate Increase to >100	25 Participants	28 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to \<=35 degrees celsius', 'increase to \>=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to \>=38 to increase to \>=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to \<=35' and 'increased to \>=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=98 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Change From Baseline in Body Temperature Decrease to <=35	1 Participants	3 Participants	0 Participants
Number of Participants With Change From Baseline in Body Temperature Change to normal or no change	86 Participants	85 Participants	21 Participants
Number of Participants With Change From Baseline in Body Temperature Increase to >=38	8 Participants	10 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: \<120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: \>=160 mmHg. For DBP: Grade 0: \<80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: \>=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, increase to Grade 2	29 Participants	41 Participants	4 Participants
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, increase to Grade 3	14 Participants	22 Participants	8 Participants
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, increase to Grade 2	18 Participants	16 Participants	2 Participants
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, increase to Grade 3	9 Participants	8 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Common non-SAE	93 Participants	96 Participants	24 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) SAE	43 Participants	53 Participants	15 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Keratopathy	67 Participants	74 Participants	23 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Dry eye events	17 Participants	25 Participants	6 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Blurred vision	24 Participants	36 Participants	10 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Thrombocytopenia	36 Participants	56 Participants	10 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Infusion-related reactions	20 Participants	16 Participants	4 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Corneal events	68 Participants	76 Participants	23 Participants
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) Neutropenia	14 Participants	28 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Up to 186 weeks

Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline \<0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from Baseline \>=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=88 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=94 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Left eye, no change/improved vision, n=88,94,24	35 Participants	45 Participants	4 Participants
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Left eye, possible worsened vision, n=88,94,24	11 Participants	15 Participants	4 Participants
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Left eye, definite worsened vision, n=88,94,24	42 Participants	34 Participants	16 Participants
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Right eye, no change/improved vision, n=87,93,23	32 Participants	38 Participants	5 Participants
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Right eye, possible worsened vision, n=87,93,23	21 Participants	13 Participants	6 Participants
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores Right eye, definite worsened vision, n=87,93,23	34 Participants	42 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 186 weeks

Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP \>=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=88 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=93 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline Right eye, n=88,93,23	17 Participants	16 Participants	8 Participants
Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline Left eye, n=88,92,24	14 Participants	15 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline and Up to 186 weeks

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=91 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=90 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=23 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)	4 Participants	12 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Up to 186 weeks

Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=93 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=23 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) Right eye,n=95,93,23	0 Participants	4 Participants	0 Participants
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) Left eye,n=93,92,22	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Up to 186 weeks

Population: Full Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=92 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=94 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) CE, Right eye, n=53,54,17	39 Participants	40 Participants	16 Participants
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) CE, Left eye,n=55,55,15	39 Participants	44 Participants	14 Participants
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) CS, Right eye,n=92,94,24	5 Participants	7 Participants	3 Participants
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) CS, Left eye,n=92,89,23	8 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Up to 186 weeks

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=95 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=99 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=24 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Active edema, Right eye, n=94,99,24	3 Participants	5 Participants	1 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Active edema, Left eye,n=95,99,24	4 Participants	4 Participants	1 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Active opacity, Right eye,n=93,97,24	3 Participants	3 Participants	3 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Active opacity, Left eye,n=94,95,24	4 Participants	4 Participants	3 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Corneal Neovascularization, Right eye,n=93,99,24	1 Participants	1 Participants	1 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Corneal Neovascularization, Left eye,n=93,99,23	1 Participants	0 Participants	1 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Corneal ulcer, Right eye,n=61,60,22	1 Participants	1 Participants	0 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Corneal ulcer, Left eye,n=63,61,20	1 Participants	2 Participants	0 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Epithelial Microcystic Edema, Right eye,n=95,99,24	15 Participants	24 Participants	9 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Epithelial Microcystic Edema, Left eye,n=95,99,23	16 Participants	25 Participants	8 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Subepithelial haze, Right eye,n=95,98,24	18 Participants	28 Participants	8 Participants
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) Subepithelial haze, Left eye,n=95,97,23	18 Participants	29 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and Up to 186 weeks

Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from \>10 seconds (Baseline) to \<=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Outcome measures

Outcome measures
Measure	Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) n=34 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) n=31 Participants Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.	Main Study: GSK2857916 3.4 mg/kg (Lyophilized) n=2 Participants Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) Left eye,n=34,30,2	14 Participants	12 Participants	2 Participants
Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) Right eye,n=30,31,2	11 Participants	12 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment.