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

• ClinicalTrials.gov Identifier: NCT03525678
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2018
• Results First Posted: April 28, 2020
• Last Update Posted: January 9, 2024
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma
• Interventions: Drug: Belantamab mafodotin frozen liquid; Drug: Belantamab mafodotin lyophilized powder
• Enrollment: 221

Participant Flow

Recruitment Details	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).
Pre-assignment Details	A total of 221 participants were enrolled in this study. The results presented are based on the data cut-off date of 04 May 2022. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continued Treatment (PACT) phase and their data will be reported after they stop receiving treatment as per protocol.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
Started	97	99	25
Received Study Treatment [1]	95	99	24
Completed [2]	0	0	0
Not Completed	97	99	25
Reason Not Completed
Withdrawal by Subject	8	2	2
Physician Decision	2	4	0
Lost to Follow-up	2	1	2
Death	70	80	16
other reasons	14	10	5
ongoing at the time of analysis	1	2	0
[1] 3 randomized participants never received treatment (2-withdrawal by physician decision and 1-death).; [2] Discontinued

Baseline Characteristics

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)	Total
Arm/Group Description		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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		97	99	25	221
Baseline Analysis Population Description		Baseline characteristics were presented for all randomized participants including 3 randomized participants who never received treatment (2-withdrawal by physician decision and 1-death).
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	97 participants	99 participants	25 participants	221 participants
		64.1 (10.01)	66.0 (9.09)	67.2 (10.78)	65.3 (10.01)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	97 participants	99 participants	25 participants	221 participants
	Female	46 47.4%	43 43.4%	11 44.0%	100 45.2%
	Male	51 52.6%	56 56.6%	14 56.0%	121 54.8%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	97 participants	99 participants	25 participants	221 participants
	Black or African American	16 16.5%	11 11.1%	3 12.0%	30 13.6%
	Asian - Central/South Asian Heritage	1 1.0%	0 0.0%	0 0.0%	1 0.5%
	Asian - East Asian Heritage	1 1.0%	0 0.0%	0 0.0%	1 0.5%
	Asian - South East Asian Heritage	0 0.0%	1 1.0%	1 4.0%	2 0.9%
	White - Arabic/North African Heritage	4 4.1%	2 2.0%	0 0.0%	6 2.7%
	White - White/Caucasian/European Heritage	72 74.2%	83 83.8%	21 84.0%	176 79.6%
	Mixed Asian Race	0 0.0%	1 1.0%	0 0.0%	1 0.5%
	Mixed White Race	0 0.0%	1 1.0%	0 0.0%	1 0.5%
	Unknown	1 1.0%	0 0.0%	0 0.0%	1 0.5%
	Missing	2 2.1%	0 0.0%	0 0.0%	2 0.9%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
Description	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.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Measure Type: Number; Number (97.5% Confidence Interval); Unit of Measure: Percentage of Participants
	31; (20.8 to 42.6)	34; (23.9 to 46.0)	48; (25.5 to 71.1)

2. Primary Outcome

Title	Overall Response Rate by Independent Review Committee (Efficacy Population)
Description	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.
Time Frame	Up to 48 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	64	66
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	30; (18.9 to 42.4)	30; (19.6 to 42.9)

3. Secondary Outcome

Title	Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	33; (23.8 to 43.3)	32; (23.3 to 42.5)	52; (31.3 to 72.2)

4. Secondary Outcome

Title	Overall Response Rate by Investigator Assessment (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	64	66
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	33; (21.6 to 45.7)	26; (15.8 to 38.0)

5. Secondary Outcome

Title	Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	35; (25.6 to 45.4)	38; (28.8 to 48.7)	60; (38.7 to 78.9)

6. Secondary Outcome

Title	Clinical Benefit Rate by Investigator Assessment (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	64	66
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	34; (22.9 to 47.3)	35; (23.5 to 47.6)

7. Secondary Outcome

Title	Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	36; (26.6 to 46.5)	40; (30.7 to 50.7)	56; (34.9 to 75.6)

8. Secondary Outcome

Title	Clinical Benefit Rate by Independent Review Committee (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	64	66
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	34; (22.9 to 47.3)	38; (26.2 to 50.7)

9. Secondary Outcome

Title	Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	32	32	13
Median (Inter-Quartile Range); Unit of Measure: Months
	12.4; (4.2 to 21.4)	12.6; (5.6 to 22.8)	5.3; (2.8 to 9.0)

10. Secondary Outcome

Title	Duration of Response by Investigator Assessment (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	21	17
Median (Inter-Quartile Range); Unit of Measure: Months
	6.9; (4.2 to 20.8)	15.9 [1]; (12.6 to NA)

[1]

<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived

11. Secondary Outcome

Title	Duration of Response by Independent Review Committee (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	31	35	13
Median (Inter-Quartile Range); Unit of Measure: Months
	12.5; (4.2 to 19.4)	6.2 [1]; (4.2 to NA)	9.0; (3.4 to 10.4)

[1]

<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

12. Secondary Outcome

Title	Duration of Response by Independent Review Committee (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	20	20
Median (Inter-Quartile Range); Unit of Measure: Months
	11.0; (4.0 to 19.4)	15.9 [1]; (4.2 to NA)

[1]

<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

13. Secondary Outcome

Title	Time to Response by Investigator Assessment (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	32	32	13
Median (Inter-Quartile Range); Unit of Measure: Months
	1.5; (0.8 to 2.5)	1.5; (0.9 to 3.0)	0.9; (0.8 to 1.0)

14. Secondary Outcome

Title	Time to Response by Investigator Assessment (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	21	17
Median (Inter-Quartile Range); Unit of Measure: Months
	1.4; (0.8 to 2.8)	1.5; (1.4 to 2.8)

15. Secondary Outcome

Title	Time to Response by Independent Review Committee (Full Analysis Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	31	35	13
Median (Inter-Quartile Range); Unit of Measure: Months
	1.5; (0.8 to 2.2)	1.4; (0.8 to 2.8)	0.9; (0.8 to 2.3)

16. Secondary Outcome

Title	Time to Response by Independent Review Committee (Efficacy Population)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	20	20
Median (Inter-Quartile Range); Unit of Measure: Months
	1.5; (0.8 to 2.5)	1.4; (1.1 to 1.9)

17. Secondary Outcome

Title	Progression Free Survival by Investigator Assessment
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Median (Inter-Quartile Range); Unit of Measure: Months
	2.2; (0.8 to 7.7)	3.2; (1.0 to 9.8)	3.6; (1.5 to 8.7)

18. Secondary Outcome

Title	Progression Free Survival by Independent Review Committee
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Median (Inter-Quartile Range); Unit of Measure: Months
	2.8; (0.9 to 9.7)	3.9; (0.8 to 9.0)	5.7; (2.2 to 9.7)

19. Secondary Outcome

Title	Time to Progression by Investigator Assessment
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Median (Inter-Quartile Range); Unit of Measure: Months
	2.2; (0.8 to 7.7)	3.9; (1.0 to 11.9)	3.6; (1.5 to 9.7)

20. Secondary Outcome

Title	Time to Progression by Independent Review Committee
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Median (Inter-Quartile Range); Unit of Measure: Months
	2.9; (0.9 to 9.7)	4.9; (0.8 to 11.1)	5.7; (2.2 to 9.7)

21. Secondary Outcome

Title	Overall Survival
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Population

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	97	99	25
Median (Inter-Quartile Range); Unit of Measure: Months
	15.3; (4.8 to 36.4)	14.0; (6.2 to 26.6)	24.5 [1]; (7.7 to NA)

[1]

<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.

22. Secondary Outcome

Title	Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Basophils, decrease to low, n=94,96,23	Number Analyzed	94 participants	96 participants	23 participants
		2 2.1%	7 7.3%	0 0.0%
Basophils, change to normal or NC, n=94,96,23	Number Analyzed	94 participants	96 participants	23 participants
		87 92.6%	85 88.5%	19 82.6%
Basophils, increase to high, n=94,96,23	Number Analyzed	94 participants	96 participants	23 participants
		5 5.3%	5 5.2%	4 17.4%
Eosinophils, decrease to low, n=95,97,23	Number Analyzed	95 participants	97 participants	23 participants
		14 14.7%	13 13.4%	0 0.0%
Eosinophils, change to normal or NC, n=95,97,23	Number Analyzed	95 participants	97 participants	23 participants
		71 74.7%	78 80.4%	16 69.6%
Eosinophils, increase to high, n=95,97,23	Number Analyzed	95 participants	97 participants	23 participants
		10 10.5%	8 8.2%	7 30.4%
Hematocrit, decrease to low, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		10 10.5%	3 3.1%	1 4.2%
Hematocrit, change to normal or NC, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		84 88.4%	94 96.9%	23 95.8%
Hematocrit, increase to high, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		3 3.2%	0 0.0%	0 0.0%
Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21	Number Analyzed	95 participants	95 participants	21 participants
		14 14.7%	17 17.9%	5 23.8%
Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21	Number Analyzed	95 participants	95 participants	21 participants
		79 83.2%	68 71.6%	14 66.7%
Mean Corpuscular Hemoglobin, increase to high, n=95,95,21	Number Analyzed	95 participants	95 participants	21 participants
		2 2.1%	12 12.6%	2 9.5%
MCH Concentration, decrease to low, n=94,96,21	Number Analyzed	94 participants	96 participants	21 participants
		20 21.3%	28 29.2%	6 28.6%
MCH Concentration, change to normal or NC, n=94,96,21	Number Analyzed	94 participants	96 participants	21 participants
		70 74.5%	66 68.8%	14 66.7%
MCH Concentration, increase to high, n=94,96,21	Number Analyzed	94 participants	96 participants	21 participants
		5 5.3%	2 2.1%	1 4.8%
Mean Corpuscular Volume, decrease to low, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		12 12.6%	15 15.5%	4 16.7%
Mean Corpuscular Volume, change to normal or NC, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		77 81.1%	73 75.3%	18 75.0%
Mean Corpuscular Volume, increase to high, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		7 7.4%	10 10.3%	3 12.5%
Monocytes, decrease to low, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		6 6.3%	10 10.3%	1 4.2%
Monocytes, change to normal or NC, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		62 65.3%	50 51.5%	12 50.0%
Monocytes, increase to high, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		28 29.5%	45 46.4%	12 50.0%
Erythrocytes, decrease to low, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		4 4.2%	1 1.0%	0 0.0%
Erythrocytes, change to normal or NC, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		91 95.8%	95 97.9%	21 87.5%
Erythrocytes, increase to high, n=95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		2 2.1%	1 1.0%	3 12.5%
Reticulocytes, decrease to low, n=73,65,19	Number Analyzed	73 participants	65 participants	19 participants
		11 15.1%	15 23.1%	7 36.8%
Reticulocytes, change to normal or NC, n=73,65,19	Number Analyzed	73 participants	65 participants	19 participants
		49 67.1%	33 50.8%	3 15.8%
Reticulocytes, increase to high, n=73,65,19	Number Analyzed	73 participants	65 participants	19 participants
		16 21.9%	21 32.3%	10 52.6%

23. Secondary Outcome

Title	Number of Participants With Grade Change From Baseline in Hematology Parameters
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	95	97	24
Measure Type: Count of Participants; Unit of Measure: Participants
Hb, Hb increased, increase to Grade 3	0 0.0%	0 0.0%	0 0.0%
Hb, Hb increased, increase to Grade 4	0 0.0%	0 0.0%	0 0.0%
Hb, Anemia, increase to Grade 3	19 20.0%	30 30.9%	5 20.8%
Hb, Anemia, increase to Grade 4	0 0.0%	0 0.0%	0 0.0%
Lymph, Lymph count increased, increase to Grade 3	0 0.0%	0 0.0%	0 0.0%
Lymph, Lymph count increased, increase to Grade 4	0 0.0%	0 0.0%	0 0.0%
Lymph, Lymph count decreased, increase to Grade 3	16 16.8%	24 24.7%	6 25.0%
Lymph, Lymph count decreased, increase to Grade 4	5 5.3%	5 5.2%	2 8.3%
Neutro, increase to Grade 3	4 4.2%	10 10.3%	2 8.3%
Neutro, increase to Grade 4	6 6.3%	3 3.1%	1 4.2%
PC, increase to Grade 3	9 9.5%	11 11.3%	1 4.2%
PC, increase to Grade 4	13 13.7%	25 25.8%	2 8.3%
Leuko, Leukocytosis, increase to Grade 3	0 0.0%	0 0.0%	0 0.0%
Leuko, Leukocytosis, increase to Grade 4	0 0.0%	0 0.0%	0 0.0%
Leuko, Leuko decreased, increase to Grade 3	5 5.3%	9 9.3%	2 8.3%
Leuko, Leuko decreased, increase to Grade 4	3 3.2%	3 3.1%	0 0.0%

24. Secondary Outcome

Title	Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Bicarbonate, decrease to low, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		12 13.3%	22 23.7%	4 16.7%
Bicarbonate, change to normal or NC, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		67 74.4%	59 63.4%	16 66.7%
Bicarbonate, increase to high, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		12 13.3%	16 17.2%	4 16.7%
Direct Bilirubin, decrease to low, n=70,72,21	Number Analyzed	70 participants	72 participants	21 participants
		0 0.0%	2 2.8%	0 0.0%
Direct Bilirubin, change to normal or NC, n=70,72,21	Number Analyzed	70 participants	72 participants	21 participants
		60 85.7%	60 83.3%	20 95.2%
Direct Bilirubin, increase to high, n=70,72,21	Number Analyzed	70 participants	72 participants	21 participants
		10 14.3%	10 13.9%	1 4.8%
Calcium, decrease to low, n=95,98,24	Number Analyzed	95 participants	98 participants	24 participants
		26 27.4%	28 28.6%	8 33.3%
Calcium, change to normal or NC, n=95,98,24	Number Analyzed	95 participants	98 participants	24 participants
		49 51.6%	48 49.0%	9 37.5%
Calcium, increase to high, n=95,98,24	Number Analyzed	95 participants	98 participants	24 participants
		29 30.5%	27 27.6%	9 37.5%
Chloride, decrease to low, n=94,97,24	Number Analyzed	94 participants	97 participants	24 participants
		17 18.1%	14 14.4%	2 8.3%
Chloride, change to normal or NC, n=94,97,24	Number Analyzed	94 participants	97 participants	24 participants
		63 67.0%	63 64.9%	20 83.3%
Chloride, increase to high, n=94,97,24	Number Analyzed	94 participants	97 participants	24 participants
		14 14.9%	24 24.7%	2 8.3%
LDH, decrease to low, n=92,98,23	Number Analyzed	92 participants	98 participants	23 participants
		1 1.1%	1 1.0%	0 0.0%
LDH, change to normal or NC, n=92,98,23	Number Analyzed	92 participants	98 participants	23 participants
		46 50.0%	51 52.0%	12 52.2%
LDH, increase to high, n=92,98,23	Number Analyzed	92 participants	98 participants	23 participants
		45 48.9%	47 48.0%	11 47.8%
Protein, decrease to low, n=94,98,24	Number Analyzed	94 participants	98 participants	24 participants
		32 34.0%	32 32.7%	8 33.3%
Protein, change to normal or NC, n=94,98,24	Number Analyzed	94 participants	98 participants	24 participants
		49 52.1%	58 59.2%	14 58.3%
Protein, increase to high, n=94,98,24	Number Analyzed	94 participants	98 participants	24 participants
		17 18.1%	11 11.2%	2 8.3%
Urea enzymatic colorimetry , decrease to low, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		10 11.1%	13 14.0%	0 0.0%
Urea enzymatic colorimetry, change to normal or NC, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		66 73.3%	56 60.2%	16 66.7%
Urea enzymatic colorimetry, increase to high, n=90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		15 16.7%	26 28.0%	8 33.3%

25. Secondary Outcome

Title	Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Gl, Hyper, increase to Grade 3, n=94,95,24	Number Analyzed	94 participants	95 participants	24 participants
		3 3.2%	5 5.3%	0 0.0%
Gl, Hyper, increase to Grade 4, n=94,95,24	Number Analyzed	94 participants	95 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Gl, Hypo, increase to Grade 3, n=94,95,24	Number Analyzed	94 participants	95 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Gl, Hypo, increase to Grade 4, n=94,95,24	Number Analyzed	94 participants	95 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Albumin, increase to Grade 3, n=94,98,24	Number Analyzed	94 participants	98 participants	24 participants
		4 4.3%	7 7.1%	1 4.2%
Albumin, increase to Grade 4, n=94,98,24	Number Analyzed	94 participants	98 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
ALP, increase to Grade 3, n=93,97,24	Number Analyzed	93 participants	97 participants	24 participants
		1 1.1%	0 0.0%	0 0.0%
ALP, increase to Grade 4, n=93,97,24	Number Analyzed	93 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
ALT, increase to Grade 3, n=93,97,24	Number Analyzed	93 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
ALT, increase to Grade 4, n=93,97,24	Number Analyzed	93 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
AST, increase to Grade 3, n=93,96,24	Number Analyzed	93 participants	96 participants	24 participants
		3 3.2%	7 7.3%	0 0.0%
AST, increase to Grade 4, n=93,96,24	Number Analyzed	93 participants	96 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
T.Bil, increase to Grade 3, n=92,97,23	Number Analyzed	92 participants	97 participants	23 participants
		0 0.0%	0 0.0%	0 0.0%
T.Bil, increase to Grade 4, n=92,97,23	Number Analyzed	92 participants	97 participants	23 participants
		0 0.0%	0 0.0%	0 0.0%
CK, increase to Grade 3, n= 87,91,24	Number Analyzed	87 participants	91 participants	24 participants
		1 1.1%	0 0.0%	1 4.2%
CK, increase to Grade 4, n= 87,91,24	Number Analyzed	87 participants	91 participants	24 participants
		2 2.3%	0 0.0%	0 0.0%
Creatinine, increase to Grade 3, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		4 4.2%	3 3.1%	0 0.0%
Creatinine, increase to Grade 4, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		1 1.1%	0 0.0%	0 0.0%
GGT, increase to Grade 3, n= 91,95,24	Number Analyzed	91 participants	95 participants	24 participants
		5 5.5%	11 11.6%	1 4.2%
GGT, increase to Grade 4, n= 91,95,24	Number Analyzed	91 participants	95 participants	24 participants
		1 1.1%	1 1.1%	0 0.0%
Pot, Hyper,increase to Grade 3, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	1 1.0%	0 0.0%
Pot, Hyper,increase to Grade 4, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Pot, Hypo, increase to Grade 3, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	4 4.1%	1 4.2%
Pot, Hypo, increase to Grade 4, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		2 2.1%	0 0.0%	0 0.0%
Mg, Hyper, increase to Grade 3, n= 91,96,24	Number Analyzed	91 participants	96 participants	24 participants
		3 3.3%	1 1.0%	0 0.0%
Mg, Hyper, increase to Grade 4, n= 91,96,24	Number Analyzed	91 participants	96 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Mg, Hypo, increase to Grade 3, n= 91,96,24	Number Analyzed	91 participants	96 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Mg, Hypo, increase to Grade 4, n= 91,96,24	Number Analyzed	91 participants	96 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Phosphate, increase to Grade 3, n= 90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		4 4.4%	8 8.6%	2 8.3%
Phosphate, increase to Grade 4, n= 90,93,24	Number Analyzed	90 participants	93 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Sod, Hyper, increase to Grade 3, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Sod, Hyper, increase to Grade 4, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Sod, Hypo, increase to Grade 3, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		2 2.1%	6 6.2%	1 4.2%
Sod, Hypo, increase to Grade 4, n= 95,97,24	Number Analyzed	95 participants	97 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Urate, increase to Grade 3, n= 93,96,24	Number Analyzed	93 participants	96 participants	24 participants
		0 0.0%	0 0.0%	0 0.0%
Urate, increase to Grade 4, n= 93,96,24	Number Analyzed	93 participants	96 participants	24 participants
		3 3.2%	5 5.2%	1 4.2%
eGFR, increase to Grade 3, n= 84,85,23	Number Analyzed	84 participants	85 participants	23 participants
		8 9.5%	11 12.9%	0 0.0%
eGFR, increase to Grade 4, n= 84,85,23	Number Analyzed	84 participants	85 participants	23 participants
		3 3.6%	1 1.2%	0 0.0%

26. Secondary Outcome

Title	Number of Participants With Abnormal Findings During Physical Examination
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

27. Secondary Outcome

Title	Number of Participants With Change From Baseline in Pulse Rate
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Decrease to <60	14 14.7%	17 17.2%	6 25.0%
Change to normal or no change	57 60.0%	55 55.6%	15 62.5%
Increase to >100	25 26.3%	28 28.3%	3 12.5%

28. Secondary Outcome

Title	Number of Participants With Change From Baseline in Body Temperature
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	95	98	24
Measure Type: Count of Participants; Unit of Measure: Participants
Decrease to <=35	1 1.1%	3 3.1%	0 0.0%
Change to normal or no change	86 90.5%	85 86.7%	21 87.5%
Increase to >=38	8 8.4%	10 10.2%	3 12.5%

29. Secondary Outcome

Title	Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
SBP, increase to Grade 2	29 30.5%	41 41.4%	4 16.7%
SBP, increase to Grade 3	14 14.7%	22 22.2%	8 33.3%
DBP, increase to Grade 2	18 18.9%	16 16.2%	2 8.3%
DBP, increase to Grade 3	9 9.5%	8 8.1%	1 4.2%

30. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Common non-SAE	93 97.9%	96 97.0%	24 100.0%
SAE	43 45.3%	53 53.5%	15 62.5%
Keratopathy	67 70.5%	74 74.7%	23 95.8%
Dry eye events	17 17.9%	25 25.3%	6 25.0%
Blurred vision	24 25.3%	36 36.4%	10 41.7%
Thrombocytopenia	36 37.9%	56 56.6%	10 41.7%
Infusion-related reactions	20 21.1%	16 16.2%	4 16.7%
Corneal events	68 71.6%	76 76.8%	23 95.8%
Neutropenia	14 14.7%	28 28.3%	2 8.3%

31. Secondary Outcome

Title	Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
Description	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.
Time Frame	Baseline (Day 1) and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		88	94	24
Measure Type: Count of Participants; Unit of Measure: Participants
Left eye, no change/improved vision, n=88,94,24	Number Analyzed	88 participants	94 participants	24 participants
		35 39.8%	45 47.9%	4 16.7%
Left eye, possible worsened vision, n=88,94,24	Number Analyzed	88 participants	94 participants	24 participants
		11 12.5%	15 16.0%	4 16.7%
Left eye, definite worsened vision, n=88,94,24	Number Analyzed	88 participants	94 participants	24 participants
		42 47.7%	34 36.2%	16 66.7%
Right eye, no change/improved vision, n=87,93,23	Number Analyzed	87 participants	93 participants	23 participants
		32 36.8%	38 40.9%	5 21.7%
Right eye, possible worsened vision, n=87,93,23	Number Analyzed	87 participants	93 participants	23 participants
		21 24.1%	13 14.0%	6 26.1%
Right eye, definite worsened vision, n=87,93,23	Number Analyzed	87 participants	93 participants	23 participants
		34 39.1%	42 45.2%	12 52.2%

32. Secondary Outcome

Title	Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline
Description	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.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		88	93	24
Measure Type: Count of Participants; Unit of Measure: Participants
Right eye, n=88,93,23	Number Analyzed	88 participants	93 participants	23 participants
		17 19.3%	16 17.2%	8 34.8%
Left eye, n=88,92,24	Number Analyzed	88 participants	92 participants	24 participants
		14 15.9%	15 16.3%	7 29.2%

33. Secondary Outcome

Title	Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)
Description	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.
Time Frame	Baseline and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	91	90	23
Measure Type: Count of Participants; Unit of Measure: Participants
	4 4.4%	12 13.3%	3 13.0%

34. Secondary Outcome

Title	Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
Description	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.
Time Frame	Baseline and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	93	23
Measure Type: Count of Participants; Unit of Measure: Participants
Right eye,n=95,93,23	Number Analyzed	95 participants	93 participants	23 participants
		0 0.0%	4 4.3%	0 0.0%
Left eye,n=93,92,22	Number Analyzed	93 participants	92 participants	22 participants
		0 0.0%	2 2.2%	0 0.0%

35. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		92	94	24
Measure Type: Count of Participants; Unit of Measure: Participants
CE, Right eye, n=53,54,17	Number Analyzed	53 participants	54 participants	17 participants
		39 73.6%	40 74.1%	16 94.1%
CE, Left eye,n=55,55,15	Number Analyzed	55 participants	55 participants	15 participants
		39 70.9%	44 80.0%	14 93.3%
CS, Right eye,n=92,94,24	Number Analyzed	92 participants	94 participants	24 participants
		5 5.4%	7 7.4%	3 12.5%
CS, Left eye,n=92,89,23	Number Analyzed	92 participants	89 participants	23 participants
		8 8.7%	5 5.6%	3 13.0%

36. Secondary Outcome

Title	Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Description	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.
Time Frame	Baseline and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Measure Type: Count of Participants; Unit of Measure: Participants
Active edema, Right eye, n=94,99,24	Number Analyzed	94 participants	99 participants	24 participants
		3 3.2%	5 5.1%	1 4.2%
Active edema, Left eye,n=95,99,24	Number Analyzed	95 participants	99 participants	24 participants
		4 4.2%	4 4.0%	1 4.2%
Active opacity, Right eye,n=93,97,24	Number Analyzed	93 participants	97 participants	24 participants
		3 3.2%	3 3.1%	3 12.5%
Active opacity, Left eye,n=94,95,24	Number Analyzed	94 participants	95 participants	24 participants
		4 4.3%	4 4.2%	3 12.5%
Corneal Neovascularization, Right eye,n=93,99,24	Number Analyzed	93 participants	99 participants	24 participants
		1 1.1%	1 1.0%	1 4.2%
Corneal Neovascularization, Left eye,n=93,99,23	Number Analyzed	93 participants	99 participants	23 participants
		1 1.1%	0 0.0%	1 4.3%
Corneal ulcer, Right eye,n=61,60,22	Number Analyzed	61 participants	60 participants	22 participants
		1 1.6%	1 1.7%	0 0.0%
Corneal ulcer, Left eye,n=63,61,20	Number Analyzed	63 participants	61 participants	20 participants
		1 1.6%	2 3.3%	0 0.0%
Epithelial Microcystic Edema, Right eye,n=95,99,24	Number Analyzed	95 participants	99 participants	24 participants
		15 15.8%	24 24.2%	9 37.5%
Epithelial Microcystic Edema, Left eye,n=95,99,23	Number Analyzed	95 participants	99 participants	23 participants
		16 16.8%	25 25.3%	8 34.8%
Subepithelial haze, Right eye,n=95,98,24	Number Analyzed	95 participants	98 participants	24 participants
		18 18.9%	28 28.6%	8 33.3%
Subepithelial haze, Left eye,n=95,97,23	Number Analyzed	95 participants	97 participants	23 participants
		18 18.9%	29 29.9%	6 26.1%

37. Secondary Outcome

Title	Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
Description	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.
Time Frame	Baseline and Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		34	31	2
Measure Type: Count of Participants; Unit of Measure: Participants
Left eye,n=34,30,2	Number Analyzed	34 participants	30 participants	2 participants
		14 41.2%	12 40.0%	2 100.0%
Right eye,n=30,31,2	Number Analyzed	30 participants	31 participants	2 participants
		11 36.7%	12 38.7%	1 50.0%

38. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM
Description	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.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1,n=26,18,18	Number Analyzed	26 participants	18 participants	18 participants
		5644; (39.6%)	6495; (54.3%)	6962; (51.4%)
Cycle 3, n=19,21,9	Number Analyzed	19 participants	21 participants	9 participants
		7848; (42.7%)	9199; (45.1%)	9694; (49.9%)

39. Secondary Outcome

Title	Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=30,20,22	Number Analyzed	30 participants	20 participants	22 participants
		4666; (45.7%)	5678; (40.1%)	5946; (37.2%)
Cycle 3, n=26,24,11	Number Analyzed	26 participants	24 participants	11 participants
		6399; (31.6%)	6941; (34.2%)	7593; (34.5%)

40. Secondary Outcome

Title	Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=32,21,22	Number Analyzed	32 participants	21 participants	22 participants
		4607; (54.4%)	5567; (51.0%)	6293; (45.7%)
Cycle 3, n=28,28,11	Number Analyzed	28 participants	28 participants	11 participants
		6033; (44.7%)	6084; (73.8%)	8388; (46.1%)

41. Secondary Outcome

Title	Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
Cycle 1, n=32,21,22	Number Analyzed	32 participants	21 participants	22 participants
		42.51; (26.3%)	52.03; (19.8%)	51.32; (18.3%)
Cycle 3, n=29,28,11	Number Analyzed	29 participants	28 participants	11 participants
		42.35; (25.6%)	45.5; (25.3%)	48.06; (17.1%)

42. Secondary Outcome

Title	Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Median (Full Range); Unit of Measure: Hours
Cycle 1, n=32,21,22	Number Analyzed	32 participants	21 participants	22 participants
		0.780; (0.42 to 2.50)	0.700; (0.43 to 2.15)	0.750; (0.48 to 2.88)
Cycle 3, n=29,28,11	Number Analyzed	29 participants	28 participants	11 participants
		0.580; (0.47 to 2.03)	0.715; (0.42 to 2.90)	0.870; (0.50 to 2.02)

43. Secondary Outcome

Title	Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours
Cycle 1, n=29,19,22	Number Analyzed	29 participants	19 participants	22 participants
		164.4; (46.2%)	165.8; (55.0%)	196.2; (40.9%)
Cycle 3, n=26,23,11	Number Analyzed	26 participants	23 participants	11 participants
		193.7; (48.4%)	214.4; (45.9%)	279.5; (40.3%)

44. Secondary Outcome

Title	AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=16,10,9	Number Analyzed	16 participants	10 participants	9 participants
		10268; (65.8%)	10209; (64.9%)	10170; (75.0%)
Cycle 3, n=10,11,3	Number Analyzed	10 participants	11 participants	3 participants
		20526; (45.1%)	18637; (69.4%)	22782; (161.1%)

45. Secondary Outcome

Title	AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=29,18,19	Number Analyzed	29 participants	18 participants	19 participants
		7305; (41.9%)	9566; (42.2%)	9029; (40.2%)
Cycle 3, n=23,24,11	Number Analyzed	23 participants	24 participants	11 participants
		11243; (34.6%)	11646; (38.0%)	15311; (43.9%)

46. Secondary Outcome

Title	AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=30,19,20	Number Analyzed	30 participants	19 participants	20 participants
		7417; (58.5%)	9628; (52.8%)	9017; (55.4%)
Cycle 3, n=27,26,11	Number Analyzed	27 participants	26 participants	11 participants
		10725; (59.4%)	11295; (80.0%)	17715; (61.0%)

47. Secondary Outcome

Title	Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
Cycle 1, n=30,19,20	Number Analyzed	30 participants	19 participants	20 participants
		48.94; (30.0%)	61.06; (26.9%)	60.08; (18.3%)
Cycle 3, n=29,28,11	Number Analyzed	29 participants	28 participants	11 participants
		49.34; (32.9%)	55.60; (26.5%)	65.07; (17.4%)

48. Secondary Outcome

Title	Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Median (Full Range); Unit of Measure: Hours
Cycle 1, n=30,19,20	Number Analyzed	30 participants	19 participants	20 participants
		1.750; (0.42 to 2.50)	1.870; (0.50 to 24.50)	0.650; (0.48 to 2.17)
Cycle 3, n=29,28,11	Number Analyzed	29 participants	28 participants	11 participants
		0.830; (0.47 to 46.05)	1.150; (0.42 to 2.90)	1.750; (0.50 to 2.02)

49. Secondary Outcome

Title	t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours
Cycle 1, n=29,17,19	Number Analyzed	29 participants	17 participants	19 participants
		241.8; (49.3%)	250.8; (70.3%)	299.8; (61.0%)
Cycle 3, n=23,23,11	Number Analyzed	23 participants	23 participants	11 participants
		352.4; (52.6%)	372.0; (49.6%)	557.3; (91.7%)

50. Secondary Outcome

Title	AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)

[1]

Cys-mcMMAF was not detectable throughout the elimination phase; therefore, AUC(0-infinity) could not be estimated.

51. Secondary Outcome

Title	AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)

[1]

Cys-mcMMAF was not detectable throughout the dosing interval; therefore, AUC(0-tau) could not be estimated.

52. Secondary Outcome

Title	AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		79.26; (61.0%)	113.57; (58.3%)	100.35; (51.8%)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		70.84; (46.9%)	74.04; (73.0%)	69.83; (36.6%)

53. Secondary Outcome

Title	Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Nanogram per milliliter
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		0.903; (63.9%)	1.148; (64.7%)	1.017; (61.4%)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		0.660; (52.3%)	0.749; (66.2%)	0.656; (47.6%)

54. Secondary Outcome

Title	Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Median (Full Range); Unit of Measure: Hours
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		22.830; (1.92 to 65.63)	23.835; (17.38 to 72.65)	24.080; (0.97 to 69.47)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		23.235; (0.58 to 46.08)	22.570; (0.55 to 70.98)	22.780; (0.50 to 71.93)

55. Secondary Outcome

Title	t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Description	Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame	Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		95	99	24
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours
Cycle 1, n=27,20,19	Number Analyzed	27 participants	20 participants	19 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)
Cycle 3, n=26,29,11	Number Analyzed	26 participants	29 participants	11 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)

[1]

Cys-mcMMAF was not detectable throughout the elimination phase; therefore, t1/2 could not be estimated.

56. Secondary Outcome

Title	Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result
Description	Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	89	92	24
Measure Type: Count of Participants; Unit of Measure: Participants
	2 2.2%	0 0.0%	0 0.0%

57. Secondary Outcome

Title	Titers of Anti-drug Antibodies Against GSK2857916
Description	Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arm GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values was not presented for the arm.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	4	2	0
Mean (Standard Deviation); Unit of Measure: Titers
	125.0 (50.00)	100.0 (0.00)

58. Secondary Outcome

Title	Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Description	The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.
Time Frame	Up to 186 weeks

Outcome Measure Data

Analysis Population Description

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 (represented by n=X in the category titles).

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		84	92	22
Measure Type: Count of Participants; Unit of Measure: Participants
Blurred Vision, n= 84,92,22	Number Analyzed	84 participants	92 participants	22 participants
		59 70.2%	67 72.8%	19 86.4%
Chills, n=43,42,13	Number Analyzed	43 participants	42 participants	13 participants
		39 90.7%	36 85.7%	12 92.3%
Constipation, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		42 50.0%	47 51.1%	17 77.3%
Decreased Appetite, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		60 71.4%	65 70.7%	16 72.7%
Fatigue, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		81 96.4%	87 94.6%	21 95.5%
General Pain, n= 79, 80, 20	Number Analyzed	79 participants	80 participants	20 participants
		78 98.7%	80 100.0%	19 95.0%
Heart Palpitations, n=37, 37, 14	Number Analyzed	37 participants	37 participants	14 participants
		35 94.6%	33 89.2%	14 100.0%
Mouth/Throat Sores, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		28 33.3%	25 27.2%	8 36.4%
Nausea, n=48, 52, 11	Number Analyzed	48 participants	52 participants	11 participants
		47 97.9%	50 96.2%	11 100.0%
Nosebleed, n=23, 33, 6	Number Analyzed	23 participants	33 participants	6 participants
		22 95.7%	33 100.0%	6 100.0%
Shortness Of Breath, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		60 71.4%	58 63.0%	17 77.3%
Vomiting, n=21, 28, 6	Number Analyzed	21 participants	28 participants	6 participants
		20 95.2%	28 100.0%	5 83.3%
Watery Eyes, n=84,92, 22	Number Analyzed	84 participants	92 participants	22 participants
		50 59.5%	59 64.1%	19 86.4%

59. Secondary Outcome

Title	Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
Description	The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time Frame	Baseline (Day 1) and up to Week 186

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	83	92	22
Mean (Standard Deviation); Unit of Measure: Scores on a scale
	-20.0 (22.60)	-19.6 (21.66)	-23.1 (23.82)

60. Secondary Outcome

Title	Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Description	The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time Frame	Baseline (Day 1) and up to Week 186

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:	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.	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.	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 Number of Participants Analyzed	83	92	22
Mean (Standard Deviation); Unit of Measure: Scores on a scale
	26.9 (29.61)	28.2 (28.49)	35.0 (29.02)

61. Secondary Outcome

Title	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Description	The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186

Outcome Measure Data

Analysis Population Description

Full Analysis Population. Only those participants who were measured analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		97	99	25
Mean (Standard Deviation); Unit of Measure: Scores on a scale
GHS/QoL,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-0.7 (20.47)	-4.1 (18.54)	1.5 (23.80)
GHS/QoL,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-3.2 (18.42)	6.0 (16.50)	1.0 (14.23)
GHS/QoL,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-2.2 (13.84)	3.7 (20.19)	0 (12.42)
GHS/QoL,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		-4.6 (16.10)	-2.5 (20.94)	7.1 (8.91)
GHS/QoL,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-2.2 (14.59)	5.1 (20.44)	2.4 (14.20)
GHS/QoL,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-1.7 (14.50)	1.9 (21.29)	11.7 (4.56)
GHS/QoL,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-4.4 (14.04)	10.7 (15.82)	12.5 (10.76)
GHS/QoL,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-3.8 (17.23)	-5.3 (13.58)	0.0 (0.00)
GHS/QoL,Week 79,n=3,2,1	Number Analyzed	3 participants	2 participants	1 participants
		2.8 (24.06)	16.7 (23.57)	16.7 [1] (NA)
GHS/QoL,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		8.3 (11.79)	1.7 (25.28)	8.3 (0.00)
GHS/QoL,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		-4.2 (17.68)	1.4 (22.00)	2.8 (4.81)
GHS/QoL,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-4.2 (17.68)	33.3 [1] (NA)	-8.3 (11.79)
GHS/QoL,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			8.3 (35.36)
GHS/QoL,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			33.3 [1] (NA)
GHS/QoL,Week 186n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-8.1 (19.50)	-11.6 (22.46)	-3.9 (15.34)
PF,,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		4.4 (15.70)	-1.0 (21.93)	-5.5 (24.18)
PF,Week 13, n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		0.7 (14.62)	4.1 (11.19)	-12.5 (23.84)
PF,,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		0.4 (13.78)	6.2 (24.87)	-4.0 (14.81)
PF,Week 25, n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		1.3 (12.16)	5.5 (25.08)	-1.0 (14.62)
PF,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-2.7 (8.66)	9.3 (22.88)	4.8 (10.69)
PF, Week 37,n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		4.0 (11.76)	15.4 (25.15)	10.7 (18.62)
PF, Week 43,n=15,14, 4	Number Analyzed	15 participants	14 participants	4 participants
		3.1 (11.23)	14.8 (26.04)	6.7 (27.22)
PF, Week 61,n=11,11, 3	Number Analyzed	11 participants	11 participants	3 participants
		4.2 (12.39)	9.7 (22.18)	15.6 (3.85)
PF, Week 79,n=3,2, 2	Number Analyzed	3 participants	2 participants	2 participants
		2.2 (3.85)	10.0 (4.71)	10.0 (4.71)
PF, Week 97,n=4,5, 3	Number Analyzed	4 participants	5 participants	3 participants
		0.0 (9.43)	0.0 (9.43)	-2.2 (23.41)
PF, Week 115,n=2,6, 3	Number Analyzed	2 participants	6 participants	3 participants
		3.3 (4.71)	4.4 (13.11)	4.4 (10.18)
PF, Week 133,n=2,1, 2	Number Analyzed	2 participants	1 participants	2 participants
		3.3 (4.71)	13.3 [1] (NA)	-6.7 (18.86)
PF, Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (18.86)
PF, Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			13.3 [1] (NA)
PF, Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-0.8 (21.20)	-6.2 (21.29)	-13.3 (24.38)
RF,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		0.3 (33.24)	-6.0 (35.68)	-7.8 (25.08)
RF,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		2.3 (33.55)	-0.6 (32.88)	-6.3 (30.96)
RF,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-4.4 (31.35)	1.9 (36.50)	-5.0 (23.64)
RF,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		2.5 (32.57)	0.0 (32.57)	11.9 (32.93)
RF,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		8.9 (24.29)	3.7 (34.09)	7.1 (21.21)
RF,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		8.9 (29.46)	3.8 (39.76)	20.0 (27.39)
RF,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		8.9 (30.12)	11.9 (32.31)	8.3 (21.52)
RF,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		12.1 (36.58)	-3.0 (29.64)	16.7 (16.67)
RF,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		5.6 (34.69)	8.3 (11.79)	8.3 (35.36)
RF,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-4.2 (43.83)	-6.7 (19.00)	5.6 (34.69)
RF,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (47.14)	-5.6 (17.21)	16.7 (44.10)
RF,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		8.3 (35.36)	16.7 [1] (NA)	25.0 (11.79)
RF,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			-16.7 (23.57)
RF,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
RF,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-0.4 (30.84)	-8.3 (33.66)	-16.7 (30.62)
EF,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		1.4 (18.86)	1.4 (27.10)	-4.4 (21.27)
EF,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-2.0 (23.00)	-0.0 (25.00)	-9.4 (23.35)
EF,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		0.4 (19.93)	3.1 (20.30)	-1.7 (21.08)
EF,Week 25, n=20, 23, 7	Number Analyzed	20 participants	23 participants	7 participants
		-4.6 (21.20)	4.0 (20.39)	-2.4 (14.20)
EF,Week 31, n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		2.2 (19.53)	0.9 (25.06)	1.2 (18.28)
EF,Week 37, n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		1.7 (13.44)	9.6 (23.29)	13.3 (16.24)
EF,Week 43, n=15,14, 4	Number Analyzed	15 participants	14 participants	4 participants
		0.0 (18.90)	8.3 (27.74)	4.2 (4.81)
EF,Week 61, n=11,11, 3	Number Analyzed	11 participants	11 participants	3 participants
		6.8 (12.81)	-5.3 (16.36)	19.4 (12.73)
EF,Week 79, n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		2.8 (4.81)	8.3 (11.79)	16.7 (23.57)
EF,Week 97, n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		2.1 (10.49)	1.7 (25.95)	8.3 (16.67)
EF,Week 115, n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (23.57)	-2.8 (11.39)	11.1 (12.73)
EF,Week 133, n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-4.2 (29.46)	16.7 [1] (NA)	8.3 (23.57)
EF,Week 151, n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			4.2 (29.46)
EF,Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			16.7 [1] (NA)
EF,Week 186, n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-6.7 (24.45)	-6.2 (21.04)	-10.8 (17.37)
CF,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		4.5 (20.55)	-2.1 (21.03)	-1.0 (20.81)
CF,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		2.3 (23.45)	-1.1 (15.39)	-15.6 (27.53)
CF,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-1.8 (26.58)	-0.6 (22.87)	-6.7 (21.08)
CF,Week 25, n=20, 23, 7	Number Analyzed	20 participants	23 participants	7 participants
		-1.7 (27.52)	1.4 (21.27)	-11.9 (18.54)
CF,Week 31, n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		6.7 (23.40)	-3.7 (19.43)	-4.8 (12.60)
CF,Week 37, n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		3.3 (22.00)	3.8 (13.87)	3.3 (13.94)
CF,Week 43, n=15,14, 4	Number Analyzed	15 participants	14 participants	4 participants
		2.2 (24.29)	1.2 (10.26)	-4.2 (8.33)
CF,Week 61, n=11,11, 3	Number Analyzed	11 participants	11 participants	3 participants
		10.6 (27.15)	-1.5 (15.73)	5.6 (9.62)
CF,Week 79, n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		11.1 (19.25)	-25.0 (35.36)	8.3 (11.79)
CF,Week 97, n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-4.2 (25.00)	-16.7 (33.33)	0.0 (16.67)
CF,Week 115, n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (23.57)	-0.0 (18.26)	11.1 (9.62)
CF,Week 133, n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-8.3 (35.36)	0.0 [1] (NA)	8.3 (11.79)
CF,Week 151, n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			-16.7 (23.57)
CF,Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
CF,Week 186, n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-3.3 (25.88)	-11.2 (26.07)	-9.8 (13.25)
SF,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		3.8 (29.02)	1.1 (32.49)	-1.0 (33.58)
SF,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-4.0 (28.75)	1.7 (28.64)	-7.3 (31.01)
SF,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-6.1 (28.44)	5.6 (28.50)	-6.7 (28.54)
SF,Week 25, n=20, 23, 7	Number Analyzed	20 participants	23 participants	7 participants
		-6.7 (26.71)	13.8 (22.84)	2.4 (32.53)
SF,Week 31, n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		2.2 (16.51)	15.7 (31.56)	2.4 (24.40)
SF,Week 37, n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		2.2 (21.70)	16.7 (29.66)	20.0 (21.73)
SF,Week 43, n=15,14, 4	Number Analyzed	15 participants	14 participants	4 participants
		-1.1 (17.21)	20.2 (30.08)	16.7 (23.57)
SF,Week 61, n=11,11, 3	Number Analyzed	11 participants	11 participants	3 participants
		7.6 (32.80)	-1.5 (17.41)	33.3 (16.67)
SF,Week 79, n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		5.6 (19.25)	8.3 (35.36)	25.0 (35.36)
SF,Week 97, n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-4.2 (43.83)	16.7 (20.41)	33.3 (16.67)
SF,Week 115, n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		16.7 (23.57)	2.8 (24.53)	27.8 (25.46)
SF,Week 133, n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		16.7 (23.57)	33.3 [1] (NA)	41.7 (11.79)
SF,Week 151, n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			16.7 (23.57)
SF,Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			33.3 [1] (NA)
SF,Week 186, n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-4.1 (26.56)	-10.1 (25.93)	-8.8 (31.80)
Fatigue,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-3.7 (21.90)	-0.5 (23.74)	-5.2 (20.83)
Fatigue,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-7.7 (23.78)	-7.7 (19.27)	-1.4 (24.97)
Fatigue,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-0.6 (22.67)	-2.9 (22.77)	-11.1 (15.71)
Fatigue,Week 25, n=20, 23, 7	Number Analyzed	20 participants	23 participants	7 participants
		3.3 (23.67)	-2.4 (21.70)	-11.1 (16.97)
Fatigue,Week 31, n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		-0.7 (21.61)	-11.7 (22.05)	-12.7 (18.62)
Fatigue,Week 37, n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		-9.6 (18.24)	-13.7 (24.07)	-20.0 (14.49)
Fatigue,Week 43, n=15,14, 4	Number Analyzed	15 participants	14 participants	4 participants
		-12.6 (17.25)	-10.3 (32.16)	-22.2 (12.83)
Fatigue,Week 61, n=11,11, 3	Number Analyzed	11 participants	11 participants	3 participants
		-12.1 (24.07)	3.0 (22.82)	-11.1 (0.00)
Fatigue,Week 79, n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		-22.2 (11.11)	-16.7 (7.86)	5.6 (23.57)
Fatigue,Week 97, n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-5.6 (26.45)	6.7 (20.18)	-25.9 (23.13)
Fatigue,Week 115, n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		-16.7 (23.57)	-3.7 (15.18)	-18.5 (23.13)
Fatigue,Week 133, n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-5.6 (39.28)	-22.2 [1] (NA)	-22.2 (15.71)
Fatigue,Week 151, n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			16.7 (23.57)
Fatigue,Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
Fatigue,Week 186, n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-1.6 (23.12)	4.1 (23.35)	6.5 (22.93)
N/V,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		2.4 (14.17)	4.3 (17.88)	2.0 (14.29)
N/V,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		2.3 (13.16)	1.1 (9.89)	7.3 (25.80)
N/V,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-1.8 (15.61)	-1.2 (15.96)	1.7 (5.27)
N/V,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		5.0 (12.21)	-0.7 (12.79)	-4.8 (12.60)
N/V,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-3.3 (6.90)	1.9 (7.86)	-2.4 (15.00)
N/V,Week 37,n=15,13, 5	Number Analyzed	15 participants	13 participants	5 participants
		-6.7 (16.43)	2.6 (11.48)	0.0 (0.00)
N/V,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-7.8 (15.26)	1.2 (7.91)	-8.3 (16.67)
N/V,Week 61, n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-4.5 (10.78)	4.5 (7.78)	0.0 (16.67)
N/V,Week 79, n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (0.00)	0.0 (0.00)	0.0 (0.00)
N/V,Week 97, n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		0.0 (0.00)	0.0 (0.00)	-11.1 (19.25)
N/V,Week 115, n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	0.0 (0.00)	-16.7 (16.67)
N/V,Week 133, n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	0.0 [1] (NA)	-25.0 (11.79)
N/V, Week 151, n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (0.00)
N/V, Week 169, n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
N/V, Week 186, n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		5.7 (24.04)	3.3 (18.47)	1.0 (21.63)
Pain,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-3.1 (28.69)	-1.1 (28.32)	8.8 (28.33)
Pain,Week 13,n=29,28,16	Number Analyzed	29 participants	28 participants	16 participants
		-4.0 (26.97)	-2.3 (25.48)	5.2 (27.02)
Pain,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		4.4 (19.12)	-8.6 (31.14)	1.7 (30.88)
Pain,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		2.5 (18.16)	-1.4 (24.57)	-0.0 (28.87)
Pain,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		4.4 (19.38)	-0.9 (23.90)	2.4 (35.26)
Pain,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-2.2 (21.70)	-10.3 (24.09)	-3.3 (24.72)
Pain,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-2.2 (15.26)	-8.3 (24.24)	4.2 (36.96)
Pain,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-10.6 (18.67)	-0.0 (21.08)	-5.6 (34.69)
Pain,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		-16.7 (16.67)	0.0 (23.57)	8.3 (58.93)
Pain,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-4.2 (20.97)	26.7 (22.36)	-0.0 (44.10)
Pain,Week 115,n=2,6, 3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	8.3 (27.39)	5.6 (53.58)
Pain,Week 133,n=2,1, 2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	16.7 [1] (NA)	16.7 (70.71)
Pain,Week 151,n=0,2, 0	Number Analyzed	0 participants	2 participants	0 participants
			33.3 (23.57)
Pain,Week 169,n=0,1, 0	Number Analyzed	0 participants	1 participants	0 participants
			16.7
Pain,Week 186,n=41,46, 17	Number Analyzed	41 participants	46 participants	17 participants
		1.6 (27.59)	1.4 (25.29)	16.7 (31.73)
Dyspnoea,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-2.1 (22.18)	2.1 (14.59)	-7.8 (18.74)
Dyspnoea,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-1.1 (18.86)	1.1 (22.68)	2.1 (30.96)
Dyspnoea,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-5.3 (20.07)	3.7 (25.04)	-16.7 (28.33)
Dyspnoea,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		-1.7 (20.16)	4.3 (18.27)	0.0 (27.22)
Dyspnoea,Week 31,n=15, 18, 7	Number Analyzed	15 participants	18 participants	7 participants
		-6.7 (18.69)	0.0 (16.17)	-9.5 (16.27)
Dyspnoea,Week 37,n=15, 13, 5	Number Analyzed	15 participants	13 participants	5 participants
		-8.9 (19.79)	12.8 (16.88)	-26.7 (27.89)
Dyspnoea,Week 43,n=15, 14, 4	Number Analyzed	15 participants	14 participants	4 participants
		-6.7 (22.54)	2.4 (15.82)	-25.0 (31.91)
Dyspnoea,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		0.0 (21.08)	3.0 (17.98)	-33.3 (33.33)
Dyspnoea,Week 79,n=3, 2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (0.00)	0.0 (0.00)	-33.3 (47.14)
Dyspnoea,Week 97,n=4, 5,3	Number Analyzed	4 participants	5 participants	3 participants
		16.7 (19.25)	0.0 (23.57)	-22.2 (38.49)
Dyspnoea,Week 115,n=2, 6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	5.6 (13.61)	-33.3 (33.33)
Dyspnoea,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	0.0 [1] (NA)	-16.7 (23.57)
Dyspnoea,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (0.00)
Dyspnoea,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
Dyspnoea,Week 186,n=41, 46,17	Number Analyzed	41 participants	46 participants	17 participants
		0.0 (19.72)	12.3 (24.70)	-9.8 (25.72)
Insomnia,Week 07,n=48, 47, 17	Number Analyzed	48 participants	47 participants	17 participants
		-6.2 (29.70)	-2.8 (26.77)	-0.0 (23.57)
Insomnia,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		0.0 (26.73)	-1.1 (25.95)	-0.0 (34.43)
Insomnia,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-8.8 (24.45)	-4.9 (28.80)	-13.3 (35.83)
Insomnia,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		-5.0 (32.94)	-7.2 (22.38)	0.0 (33.33)
Insomnia,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-17.8 (27.79)	-9.3 (33.93)	4.8 (40.50)
Insomnia,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-15.6 (33.01)	-10.3 (16.01)	-13.3 (38.01)
Insomnia,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-15.6 (30.52)	-4.8 (22.10)	-0.0 (47.14)
Insomnia,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-9.1 (15.57)	-9.1 (21.56)	-11.1 (19.25)
Insomnia,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (33.33)	16.7 (23.57)	-33.3 (47.14)
Insomnia,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-25.0 (31.91)	-6.7 (14.91)	-44.4 (38.49)
Insomnia,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		-33.3 (47.14)	5.6 (25.09)	-33.3 (33.33)
Insomnia,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-16.7 (70.71)	0.0 [1] (NA)	-66.7 (0.00)
Insomnia,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (0.00)
Insomnia,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
Insomnia,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		2.4 (33.66)	-2.9 (32.07)	2.0 (29.98)
AL,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		4.9 (24.78)	2.1 (29.00)	2.0 (27.56)
AL,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		8.0 (29.08)	-2.3 (25.09)	12.5 (26.87)
AL,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		0.0 (24.85)	-0.0 (38.12)	-3.3 (10.54)
AL,Week 25,n=20, 23, 7	Number Analyzed	20 participants	23 participants	7 participants
		6.7 (31.72)	-5.8 (21.68)	-9.5 (16.27)
AL,Week 31,n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		-8.9 (15.26)	0.0 (19.80)	-4.8 (23.00)
AL,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-4.4 (17.21)	-5.1 (22.96)	-20.0 (18.26)
AL,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-4.4 (17.21)	-9.5 (24.21)	-25.0 (16.67)
AL,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-6.1 (20.10)	0.0 (36.51)	11.1 (19.25)
AL,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		-33.3 (0.00)	16.7 (23.57)	16.7 (23.57)
AL,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-8.3 (16.67)	13.3 (18.26)	0.0 (33.33)
AL,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	0.0 (21.08)	0.0 (33.33)
AL,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	0.0 [1] (NA)	-16.7 (23.57)
AL,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			33.3 (47.14)
AL,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
AL,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		5.7 (24.61)	-0.0 (32.96)	2.0 (21.96)
Constipation,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		1.4 (22.76)	-2.1 (17.59)	-7.8 (25.08)
Constipation,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		0.0 (25.20)	-5.7 (17.97)	8.3 (31.03)
Constipation,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-7.0 (21.02)	1.2 (17.25)	-3.3 (18.92)
Constipation,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		-3.3 (14.91)	-1.4 (18.74)	-14.3 (32.53)
Constipation,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-4.4 (11.73)	-3.7 (15.71)	-19.0 (26.23)
Constipation,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		2.2 (23.46)	-5.1 (22.96)	-20.0 (38.01)
Constipation,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-4.4 (17.21)	-2.4 (20.52)	-16.7 (43.03)
Constipation,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		0.0 (14.91)	-9.1 (30.15)	-11.1 (38.49)
Constipation,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (0.00)	0.0 (0.00)	0.0 (47.14)
Constipation,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		0.0 (0.00)	0.0 (0.00)	-22.2 (50.92)
Constipation,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	-5.6 (13.61)	-22.2 (50.92)
Constipation,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	0.0 [1] (NA)	-50.0 (23.57)
Constipation,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (0.00)
Constipation,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
Constipation,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		5.7 (20.95)	3.6 (20.16)	3.9 (33.09)
Diarrhoea,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-2.8 (26.48)	-0.0 (28.66)	-2.0 (24.92)
Diarrhoea,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		0.0 (25.20)	-6.9 (18.64)	4.2 (31.91)
Diarrhoea,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		1.8 (26.00)	-2.5 (24.33)	-3.3 (18.92)
Diarrhoea,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		3.3 (28.41)	-7.2 (33.27)	-19.0 (17.82)
Diarrhoea,Week 31,n=15,18,7	Number Analyzed	15 participants	18 participants	7 participants
		-2.2 (23.46)	-3.7 (34.09)	-4.8 (29.99)
Diarrhoea,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-2.2 (23.46)	2.6 (28.74)	-20.0 (18.26)
Diarrhoea,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-4.4 (21.33)	14.3 (28.39)	-16.7 (19.25)
Diarrhoea,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		0.0 (21.08)	15.2 (31.14)	0.0 (33.33)
Diarrhoea,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (0.00)	0.0 (0.00)	0.0 (47.14)
Diarrhoea,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-8.3 (16.67)	0.0 (0.00)	-22.2 (19.25)
Diarrhoea,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	0.0 (0.00)	-22.2 (19.25)
Diarrhoea,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		0.0 (0.00)	0.0 [1] (NA)	-33.3 (0.00)
Diarrhoea,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (0.00)
Diarrhoea,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
Diarrhoea,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-0.8 (21.72)	-5.1 (28.08)	0.0 (35.36)
FD,Week 07,n=48,47,17	Number Analyzed	48 participants	47 participants	17 participants
		-4.9 (25.72)	2.8 (24.90)	0.0 (16.67)
FD,Week 13,n=29,29,16	Number Analyzed	29 participants	29 participants	16 participants
		-4.6 (23.10)	4.6 (19.36)	10.4 (20.07)
FD,Week 19,n=19,27,10	Number Analyzed	19 participants	27 participants	10 participants
		-7.0 (21.02)	3.7 (26.69)	10.0 (22.50)
FD,Week 25,n=20,23,7	Number Analyzed	20 participants	23 participants	7 participants
		-3.3 (26.27)	-1.4 (15.82)	0.0 (19.25)
FD,Week 31,n=15,18, 7	Number Analyzed	15 participants	18 participants	7 participants
		-6.7 (22.54)	-1.9 (17.98)	4.8 (23.00)
FD,Week 37,n=15,13,5	Number Analyzed	15 participants	13 participants	5 participants
		-2.2 (23.46)	-2.6 (16.45)	6.7 (14.91)
FD,Week 43,n=15,14,4	Number Analyzed	15 participants	14 participants	4 participants
		-6.7 (18.69)	0.0 (22.65)	8.3 (31.91)
FD,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-12.1 (37.34)	6.1 (29.13)	11.1 (19.25)
FD,Week 79,n=3,2,1	Number Analyzed	3 participants	2 participants	1 participants
		0.0 (0.00)	-16.7 (23.57)	0.0 [1] (NA)
FD,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-25.0 (31.91)	0.0 (23.57)	-11.1 (19.25)
FD,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		0.0 (0.00)	22.2 (50.18)	-11.1 (19.25)
FD,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-50.0 (23.57)	-33.3 [1] (NA)	-16.7 (23.57)
FD,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			-33.3 (0.00)
FD,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			-33.3 [1] (NA)
FD,Week 186,n=41,46,17	Number Analyzed	41 participants	46 participants	17 participants
		-1.6 (24.67)	12.3 (25.68)	5.9 (21.20)

[1]

NA indicates SD could not be calculated for a single participant.

62. Secondary Outcome

Title	Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Description	The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186

Outcome Measure Data

Analysis Population Description

Full Analysis Population. Only those participants who were measured analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field

Arm/Group Title		GSK2857916 2.5 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Frozen Liquid)	GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description:		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.	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.	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 Number of Participants Analyzed		97	99	25
Mean (Standard Deviation); Unit of Measure: Scores on a scale
FP,Week 07,n=47,45,16	Number Analyzed	47 participants	45 participants	16 participants
		2.8 (25.11)	4.2 (29.99)	8.3 (24.51)
FP,Week 13,n=28,28,15	Number Analyzed	28 participants	28 participants	15 participants
		-2.0 (24.39)	8.3 (22.55)	-2.2 (27.28)
FP,Week 19,n=18,25,10	Number Analyzed	18 participants	25 participants	10 participants
		3.7 (22.87)	10.7 (20.91)	3.3 (27.24)
FP,Week 25,n=19,23,7	Number Analyzed	19 participants	23 participants	7 participants
		2.3 (27.11)	13.5 (29.39)	4.8 (31.98)
FP,Week 31,n=14,18,7	Number Analyzed	14 participants	18 participants	7 participants
		7.1 (18.80)	19.1 (24.93)	7.9 (27.00)
FP,Week 37,n=14,13,5	Number Analyzed	14 participants	13 participants	5 participants
		6.3 (17.28)	29.1 (22.47)	11.1 (31.43)
FP,Week 43,n=15,13,4	Number Analyzed	15 participants	13 participants	4 participants
		8.1 (21.19)	29.9 (26.98)	8.3 (5.56)
FP,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		10.1 (18.89)	4.0 (20.65)	25.9 (54.81)
FP,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		-7.4 (6.42)	33.3 (31.43)	38.9 (39.28)
FP,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		5.6 (14.34)	17.8 (39.75)	22.2 (40.06)
FP,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		11.1 (15.71)	16.7 (25.09)	33.3 (58.79)
FP,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		27.8 (7.86)	55.6 [1] (NA)	38.9 (55.00)
FP,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			44.4 (15.71)
FP,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			55.6 [1] (NA)
FP,Week 186,n=39,46,16	Number Analyzed	39 participants	46 participants	16 participants
		-9.4 (19.34)	-7.7 (26.69)	3.5 (24.59)
BI,Week 07,n=47,45,16	Number Analyzed	47 participants	45 participants	16 participants
		2.8 (22.87)	9.6 (28.09)	4.2 (43.67)
BI,Week 13,n=28,28,15	Number Analyzed	28 participants	28 participants	15 participants
		6.0 (25.75)	6.0 (35.20)	-4.4 (37.52)
BI,Week 19,n=18,25,10	Number Analyzed	18 participants	25 participants	10 participants
		5.6 (23.57)	8.0 (25.96)	-3.3 (42.89)
BI,Week 25,n=19,23,7	Number Analyzed	19 participants	23 participants	7 participants
		7.0 (23.78)	15.9 (31.57)	9.5 (53.45)
BI,Week 31,n=14,18,7	Number Analyzed	14 participants	18 participants	7 participants
		2.4 (20.52)	14.8 (30.73)	9.5 (56.81)
BI,Week 37,n=14,13,5	Number Analyzed	14 participants	13 participants	5 participants
		9.5 (27.51)	25.6 (30.89)	26.7 (54.77)
BI,Week 43,n=15,13,4	Number Analyzed	15 participants	13 participants	4 participants
		4.4 (24.77)	28.2 (38.12)	8.3 (16.67)
BI,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		6.1 (25.03)	12.1 (26.97)	33.3 (57.74)
BI,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		0.0 (0.00)	0.0 (0.00)	33.3 (94.28)
BI,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		8.3 (31.91)	6.7 (27.89)	44.4 (69.39)
BI,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		-16.7 (70.71)	5.6 (25.09)	55.6 (50.92)
BI,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		16.7 (23.57)	0.0 [1] (NA)	83.3 (23.57)
BI,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			16.7 (23.57)
BI,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			0.0 [1] (NA)
BI,Week 186,n=39,46,16	Number Analyzed	39 participants	46 participants	16 participants
		-4.3 (30.76)	-0.7 (35.48)	10.4 (41.67)
DS,Week 07,n=47,45,16	Number Analyzed	47 participants	45 participants	16 participants
		-1.8 (19.73)	-1.0 (17.78)	-2.8 (12.17)
DS,Week 13,n=28,28,15	Number Analyzed	28 participants	28 participants	15 participants
		-1.0 (16.22)	-3.2 (22.95)	1.1 (25.65)
DS,Week 19,n=18,25,10	Number Analyzed	18 participants	25 participants	10 participants
		0.9 (14.91)	-6.4 (17.98)	-1.7 (20.63)
DS,Week 25,n=19,23,7	Number Analyzed	19 participants	23 participants	7 participants
		-0.0 (16.25)	-3.6 (17.78)	-1.6 (25.20)
DS,Week 31,n=14,18,7	Number Analyzed	14 participants	18 participants	7 participants
		-3.6 (10.59)	-10.5 (19.23)	-4.8 (23.88)
DS,Week 37,n=14,13,5	Number Analyzed	14 participants	13 participants	5 participants
		-6.0 (12.22)	-9.8 (22.92)	-14.4 (16.01)
DS,Week 43,n=15,13,4	Number Analyzed	15 participants	13 participants	4 participants
		-5.9 (12.51)	-14.5 (24.06)	-8.3 (26.64)
DS,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-11.6 (12.29)	-7.6 (10.02)	-11.1 (16.67)
DS,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		-16.7 (11.11)	-2.8 (3.93)	-2.8 (27.50)
DS,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-12.5 (15.30)	-3.3 (15.52)	-7.4 (25.05)
DS,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		-19.4 (3.93)	-7.4 (10.92)	-10.0 (16.59)
DS,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		-13.9 (11.79)	-5.6 [1] (NA)	8.3 (51.07)
DS,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			5.6 (15.71)
DS,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			-5.6 [1] (NA)
DS,Week 186, n=39,46,16	Number Analyzed	39 participants	46 participants	16 participants
		-0.6 (17.28)	2.5 (18.36)	4.9 (24.50)
SET,Week 07,n=47,45,16	Number Analyzed	47 participants	45 participants	16 participants
		1.5 (9.21)	0.4 (13.33)	0.2 (15.49)
SET,Week 13,n=28,28,15	Number Analyzed	28 participants	28 participants	15 participants
		2.0 (10.44)	-1.7 (11.96)	6.8 (23.69)
SET,Week 19,n=18,25,10	Number Analyzed	18 participants	25 participants	10 participants
		0.0 (10.40)	-1.2 (10.87)	0.9 (9.04)
SET,Week 25,n=19,23,7	Number Analyzed	19 participants	23 participants	7 participants
		3.4 (8.41)	0.1 (13.10)	0.4 (6.45)
SET,Week 31,n=14,18,7	Number Analyzed	14 participants	18 participants	7 participants
		2.0 (6.07)	-2.9 (13.87)	5.5 (11.12)
SET,Week 37,n=14,13,5	Number Analyzed	14 participants	13 participants	5 participants
		2.2 (6.91)	-6.0 (17.82)	-1.8 (4.04)
SET,Week 43,n=15,13,4	Number Analyzed	15 participants	13 participants	4 participants
		1.0 (8.81)	-5.6 (19.05)	-4.9 (5.76)
SET,Week 61,n=11,11,3	Number Analyzed	11 participants	11 participants	3 participants
		-2.1 (12.32)	1.9 (12.82)	2.0 (9.84)
SET,Week 79,n=3,2,2	Number Analyzed	3 participants	2 participants	2 participants
		5.9 (11.40)	9.1 (12.83)	-1.3 (4.45)
SET,Week 97,n=4,5,3	Number Analyzed	4 participants	5 participants	3 participants
		-0.2 (5.42)	5.0 (13.80)	-4.7 (3.44)
SET,Week 115,n=2,6,3	Number Analyzed	2 participants	6 participants	3 participants
		5.7 (13.36)	0.7 (7.21)	-1.0 (7.09)
SET,Week 133,n=2,1,2	Number Analyzed	2 participants	1 participants	2 participants
		5.7 (13.36)	-7.4 [1] (NA)	-8.1 (5.24)
SET,Week 151,n=0,2,0	Number Analyzed	0 participants	2 participants	0 participants
			0.0 (15.71)
SET,Week 169,n=0,1,0	Number Analyzed	0 participants	1 participants	0 participants
			-11.1 [1] (NA)
SET,Week 186,n=39,46,16	Number Analyzed	39 participants	46 participants	16 participants
		4.0 (10.98)	4.0 (12.61)	3.7 (10.75)

[1]

NA indicates SD could not be calculated for a single participant.

Adverse Events

Time Frame	All-cause mortality, Serious adverse events (SAEs) and (>=5%) non-serious AEs (Non SAEs) were collected from the start of study treatment until maximum of 186 weeks
Adverse Event Reporting Description	SAEs & non-SAEs reported for Full Safety Population comprised all participants who received atleast 1 dose of study treatment(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment & thus excluded from reporting SAEs & non SAEs. All-cause mortality reported for Full Analysis Population(221) comprised all randomized participants whether or not randomized treatment was administered. The results presented are based on data cut-off date 04 May 2022.
Arm/Group Title	GSK2857916 2.5 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Lyophilized)
Arm/Group Description	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.		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.		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.
All-Cause Mortality
	GSK2857916 2.5 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Lyophilized)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	70/97 (72.16%)		80/99 (80.81%)		16/25 (64.00%)
Serious Adverse Events
	GSK2857916 2.5 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Lyophilized)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/95 (45.26%)		53/99 (53.54%)		15/24 (62.50%)
Blood and lymphatic system disorders
Thrombocytopenia † 1	1/95 (1.05%)	2	3/99 (3.03%)	3	3/24 (12.50%)	3
Anaemia † 1	1/95 (1.05%)	1	3/99 (3.03%)	3	0/24 (0.00%)	0
Febrile neutropenia † 1	0/95 (0.00%)	0	3/99 (3.03%)	3	0/24 (0.00%)	0
Hyperviscosity syndrome † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Pancytopenia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Cardiac disorders
Cardiac arrest † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Pericardial effusion † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Atrial fibrillation † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	3
Cardiac failure † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Cardiac failure acute † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Cardiac failure congestive † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Mitral valve disease † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Pericarditis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Tachycardia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Ventricular tachycardia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Eye disorders
Keratopathy † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Ulcerative keratitis † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Gastrointestinal disorders
Gastrointestinal haemorrhage † 1	2/95 (2.11%)	2	2/99 (2.02%)	2	0/24 (0.00%)	0
Vomiting † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Ascites † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Colitis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Constipation † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Diarrhoea † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Gastric fibrosis † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Haematochezia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Intestinal haemorrhage † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Large intestinal haemorrhage † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Large intestinal obstruction † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Pancreatitis † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
General disorders
Pyrexia † 1	7/95 (7.37%)	8	5/99 (5.05%)	7	0/24 (0.00%)	0
General physical health deterioration † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Chest pain † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Fatigue † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Influenza like illness † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Non-cardiac chest pain † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Hepatobiliary disorders
Bile duct stone † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Cholestasis † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Immune system disorders
Haemophagocytic lymphohistiocytosis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Infections and infestations
Pneumonia † 1	7/95 (7.37%)	8	14/99 (14.14%)	16	1/24 (4.17%)	1
Sepsis † 1	2/95 (2.11%)	2	2/99 (2.02%)	2	0/24 (0.00%)	0
Cellulitis † 1	1/95 (1.05%)	2	2/99 (2.02%)	2	0/24 (0.00%)	0
Device related infection † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Escherichia urinary tract infection † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Influenza † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Pneumonia influenzal † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	1/24 (4.17%)	1
Staphylococcal sepsis † 1	2/95 (2.11%)	2	0/99 (0.00%)	0	0/24 (0.00%)	0
Upper respiratory tract infection † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Vascular device infection † 1	2/95 (2.11%)	2	0/99 (0.00%)	0	0/24 (0.00%)	0
Brain abscess † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Device related sepsis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Enterocolitis infectious † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Epiglottitis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Escherichia bacteraemia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Escherichia sepsis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Gastroenteritis viral † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Herpes simplex pneumonia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Infective keratitis † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Lower respiratory tract infection † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Nocardiosis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Otitis media † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Pneumonia legionella † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Pneumonia respiratory syncytial viral † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Sinusitis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Staphylococcal bacteraemia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Staphylococcal infection † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Urinary tract infection † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Viral infection † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Injury, poisoning and procedural complications
Infusion related reaction † 1	3/95 (3.16%)	4	2/99 (2.02%)	2	0/24 (0.00%)	0
Spinal compression fracture † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Clavicle fracture † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Fall † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Fracture † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Humerus fracture † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Road traffic accident † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Subdural haematoma † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Tibia fracture † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Upper limb fracture † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Investigations
Alanine aminotransferase increased † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Aspartate aminotransferase increased † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Blood lactate dehydrogenase increased † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Electrocardiogram T wave inversion † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Metabolism and nutrition disorders
Hypercalcaemia † 1	4/95 (4.21%)	4	0/99 (0.00%)	0	1/24 (4.17%)	1
Dehydration † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	2/24 (8.33%)	2
Hypokalaemia † 1	2/95 (2.11%)	2	0/99 (0.00%)	0	0/24 (0.00%)	0
Hyponatraemia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	1/24 (4.17%)	1
Hyperglycaemia † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Hypocalcaemia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Hypomagnesaemia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Hypophosphataemia † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Muscular weakness † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	1/24 (4.17%)	1
Osteolysis † 1	0/95 (0.00%)	0	2/99 (2.02%)	2	0/24 (0.00%)	0
Osteonecrosis of jaw † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	1/24 (4.17%)	1
Arthritis † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Bone pain † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Haematoma muscle † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Lumbar spinal stenosis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Pain in extremity † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Pathological fracture † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Spinal osteoarthritis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	1/24 (4.17%)	1
Acute myeloid leukaemia † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Metastases to meninges † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Prostate cancer † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Squamous cell carcinoma † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Nervous system disorders
Cerebral haemorrhage † 1	0/95 (0.00%)	0	3/99 (3.03%)	3	0/24 (0.00%)	0
Cognitive disorder † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Headache † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Lethargy † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Posterior reversible encephalopathy syndrome † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Seizure † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Spinal cord compression † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	1/24 (4.17%)	1
Psychiatric disorders
Confusional state † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Delirium † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	2/95 (2.11%)	2	1/99 (1.01%)	1	0/24 (0.00%)	0
Renal failure † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Renal impairment † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Urinary retention † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion † 1	2/95 (2.11%)	2	1/99 (1.01%)	1	1/24 (4.17%)	1
Epistaxis † 1	1/95 (1.05%)	1	2/99 (2.02%)	2	0/24 (0.00%)	0
Hypoxia † 1	1/95 (1.05%)	1	1/99 (1.01%)	1	0/24 (0.00%)	0
Chronic obstructive pulmonary disease † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Cough † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Dyspnoea † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Respiratory failure † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
Vascular disorders
Haematoma † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	1/24 (4.17%)	1
Aortic stenosis † 1	0/95 (0.00%)	0	1/99 (1.01%)	1	0/24 (0.00%)	0
Hypertension † 1	1/95 (1.05%)	1	0/99 (0.00%)	0	0/24 (0.00%)	0
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	GSK2857916 2.5 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Frozen Liquid)		GSK2857916 3.4 mg/kg (Lyophilized)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/95 (97.89%)		96/99 (96.97%)		24/24 (100.00%)
Blood and lymphatic system disorders
Thrombocytopenia † 1	22/95 (23.16%)	34	44/99 (44.44%)	73	8/24 (33.33%)	12
Anaemia † 1	25/95 (26.32%)	28	36/99 (36.36%)	49	8/24 (33.33%)	14
Neutropenia † 1	7/95 (7.37%)	17	18/99 (18.18%)	27	1/24 (4.17%)	4
Leukopenia † 1	9/95 (9.47%)	9	7/99 (7.07%)	8	0/24 (0.00%)	0
Lymphopenia † 1	6/95 (6.32%)	6	5/99 (5.05%)	5	1/24 (4.17%)	1
Eye disorders
Keratopathy † 1	67/95 (70.53%)	267	74/99 (74.75%)	320	23/24 (95.83%)	100
Vision blurred † 1	22/95 (23.16%)	37	30/99 (30.30%)	50	8/24 (33.33%)	13
Dry eye † 1	14/95 (14.74%)	18	19/99 (19.19%)	21	5/24 (20.83%)	10
Photophobia † 1	7/95 (7.37%)	12	9/99 (9.09%)	16	3/24 (12.50%)	3
Visual acuity reduced † 1	5/95 (5.26%)	8	5/99 (5.05%)	5	3/24 (12.50%)	3
Blepharitis † 1	2/95 (2.11%)	3	6/99 (6.06%)	6	0/24 (0.00%)	0
Diplopia † 1	2/95 (2.11%)	3	4/99 (4.04%)	5	2/24 (8.33%)	2
Eye pruritus † 1	2/95 (2.11%)	2	5/99 (5.05%)	10	1/24 (4.17%)	1
Gastrointestinal disorders
Nausea † 1	24/95 (25.26%)	29	32/99 (32.32%)	40	2/24 (8.33%)	3
Diarrhoea † 1	11/95 (11.58%)	14	15/99 (15.15%)	15	4/24 (16.67%)	4
Vomiting † 1	8/95 (8.42%)	11	21/99 (21.21%)	23	0/24 (0.00%)	0
Constipation † 1	12/95 (12.63%)	13	9/99 (9.09%)	9	4/24 (16.67%)	5
General disorders
Fatigue † 1	15/95 (15.79%)	19	28/99 (28.28%)	37	12/24 (50.00%)	13
Pyrexia † 1	18/95 (18.95%)	21	22/99 (22.22%)	29	4/24 (16.67%)	6
Asthenia † 1	3/95 (3.16%)	3	11/99 (11.11%)	11	2/24 (8.33%)	2
Chills † 1	8/95 (8.42%)	8	4/99 (4.04%)	4	2/24 (8.33%)	2
Oedema peripheral † 1	5/95 (5.26%)	5	4/99 (4.04%)	10	3/24 (12.50%)	5
Pain † 1	5/95 (5.26%)	5	4/99 (4.04%)	4	0/24 (0.00%)	0
Chest pain † 1	2/95 (2.11%)	2	2/99 (2.02%)	2	3/24 (12.50%)	3
Infections and infestations
Upper respiratory tract infection † 1	10/95 (10.53%)	12	20/99 (20.20%)	24	4/24 (16.67%)	4
Urinary tract infection † 1	6/95 (6.32%)	7	9/99 (9.09%)	16	1/24 (4.17%)	1
Pneumonia † 1	2/95 (2.11%)	2	5/99 (5.05%)	5	2/24 (8.33%)	2
Bronchitis † 1	6/95 (6.32%)	6	2/99 (2.02%)	2	0/24 (0.00%)	0
Nasopharyngitis † 1	1/95 (1.05%)	1	5/99 (5.05%)	6	0/24 (0.00%)	0
Injury, poisoning and procedural complications
Infusion related reaction † 1	15/95 (15.79%)	16	9/99 (9.09%)	10	2/24 (8.33%)	2
Contusion † 1	0/95 (0.00%)	0	8/99 (8.08%)	8	2/24 (8.33%)	2
Fall † 1	3/95 (3.16%)	4	0/99 (0.00%)	0	2/24 (8.33%)	2
Rib fracture † 1	1/95 (1.05%)	1	2/99 (2.02%)	2	2/24 (8.33%)	2
Investigations
Aspartate aminotransferase increased † 1	21/95 (22.11%)	26	24/99 (24.24%)	30	6/24 (25.00%)	8
Platelet count decreased † 1	15/95 (15.79%)	18	11/99 (11.11%)	26	3/24 (12.50%)	3
Gamma-glutamyltransferase increased † 1	10/95 (10.53%)	10	14/99 (14.14%)	14	2/24 (8.33%)	2
Lymphocyte count decreased † 1	13/95 (13.68%)	15	10/99 (10.10%)	13	2/24 (8.33%)	3
Blood creatinine increased † 1	10/95 (10.53%)	11	11/99 (11.11%)	14	2/24 (8.33%)	2
Blood alkaline phosphatase increased † 1	9/95 (9.47%)	10	11/99 (11.11%)	11	1/24 (4.17%)	1
Neutrophil count decreased † 1	7/95 (7.37%)	10	11/99 (11.11%)	13	2/24 (8.33%)	2
Intraocular pressure increased † 1	6/95 (6.32%)	10	8/99 (8.08%)	8	5/24 (20.83%)	6
White blood cell count decreased † 1	7/95 (7.37%)	8	9/99 (9.09%)	11	0/24 (0.00%)	0
Blood lactate dehydrogenase increased † 1	4/95 (4.21%)	5	7/99 (7.07%)	8	4/24 (16.67%)	4
Weight decreased † 1	8/95 (8.42%)	8	2/99 (2.02%)	2	1/24 (4.17%)	1
Alanine aminotransferase increased † 1	6/95 (6.32%)	6	4/99 (4.04%)	5	0/24 (0.00%)	0
Urine albumin/creatinine ratio increased † 1	2/95 (2.11%)	2	8/99 (8.08%)	8	0/24 (0.00%)	0
C-reactive protein increased † 1	3/95 (3.16%)	3	5/99 (5.05%)	5	1/24 (4.17%)	1
Blood creatine phosphokinase increased † 1	5/95 (5.26%)	13	3/99 (3.03%)	3	0/24 (0.00%)	0
Blood bilirubin increased † 1	1/95 (1.05%)	1	1/99 (1.01%)	2	2/24 (8.33%)	2
Bacterial test positive † 1	0/95 (0.00%)	0	0/99 (0.00%)	0	2/24 (8.33%)	2
Metabolism and nutrition disorders
Decreased appetite † 1	12/95 (12.63%)	16	19/99 (19.19%)	21	5/24 (20.83%)	5
Hypercalcaemia † 1	10/95 (10.53%)	11	15/99 (15.15%)	17	4/24 (16.67%)	5
Hyponatraemia † 1	5/95 (5.26%)	6	12/99 (12.12%)	14	4/24 (16.67%)	4
Hypokalaemia † 1	5/95 (5.26%)	5	12/99 (12.12%)	13	3/24 (12.50%)	7
Hypophosphataemia † 1	7/95 (7.37%)	10	8/99 (8.08%)	11	3/24 (12.50%)	3
Hyperuricaemia † 1	9/95 (9.47%)	23	7/99 (7.07%)	7	1/24 (4.17%)	1
Hyperglycaemia † 1	5/95 (5.26%)	9	7/99 (7.07%)	11	3/24 (12.50%)	4
Hypoalbuminaemia † 1	4/95 (4.21%)	4	8/99 (8.08%)	12	1/24 (4.17%)	1
Hypomagnesaemia † 1	5/95 (5.26%)	7	6/99 (6.06%)	8	1/24 (4.17%)	1
Hypocalcaemia † 1	4/95 (4.21%)	4	3/99 (3.03%)	3	2/24 (8.33%)	2
Musculoskeletal and connective tissue disorders
Arthralgia † 1	19/95 (20.00%)	24	16/99 (16.16%)	19	4/24 (16.67%)	6
Back pain † 1	12/95 (12.63%)	13	12/99 (12.12%)	12	6/24 (25.00%)	6
Pain in extremity † 1	8/95 (8.42%)	8	12/99 (12.12%)	16	1/24 (4.17%)	1
Musculoskeletal chest pain † 1	7/95 (7.37%)	7	7/99 (7.07%)	9	1/24 (4.17%)	1
Bone pain † 1	4/95 (4.21%)	5	9/99 (9.09%)	10	0/24 (0.00%)	0
Muscular weakness † 1	2/95 (2.11%)	2	6/99 (6.06%)	6	0/24 (0.00%)	0
Myalgia † 1	2/95 (2.11%)	2	4/99 (4.04%)	5	2/24 (8.33%)	2
Nervous system disorders
Headache † 1	11/95 (11.58%)	12	17/99 (17.17%)	22	5/24 (20.83%)	6
Dizziness † 1	1/95 (1.05%)	1	7/99 (7.07%)	8	1/24 (4.17%)	1
Psychiatric disorders
Insomnia † 1	6/95 (6.32%)	6	1/99 (1.01%)	1	2/24 (8.33%)	2
Depression † 1	5/95 (5.26%)	5	2/99 (2.02%)	3	0/24 (0.00%)	0
Confusional state † 1	0/95 (0.00%)	0	5/99 (5.05%)	6	1/24 (4.17%)	1
Renal and urinary disorders
Proteinuria † 1	5/95 (5.26%)	11	3/99 (3.03%)	21	3/24 (12.50%)	3
Haematuria † 1	2/95 (2.11%)	8	1/99 (1.01%)	1	2/24 (8.33%)	2
Respiratory, thoracic and mediastinal disorders
Cough † 1	10/95 (10.53%)	11	19/99 (19.19%)	20	3/24 (12.50%)	4
Epistaxis † 1	9/95 (9.47%)	11	17/99 (17.17%)	21	1/24 (4.17%)	1
Dyspnoea † 1	8/95 (8.42%)	8	6/99 (6.06%)	7	3/24 (12.50%)	3
Oropharyngeal pain † 1	1/95 (1.05%)	1	5/99 (5.05%)	5	1/24 (4.17%)	1
Skin and subcutaneous tissue disorders
Hyperhidrosis † 1	3/95 (3.16%)	3	2/99 (2.02%)	2	2/24 (8.33%)	2
Vascular disorders
Hypertension † 1	9/95 (9.47%)	10	10/99 (10.10%)	11	2/24 (8.33%)	6
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

Publications:

S Lonial, HC Lee, A Badros, S Trudel, AK Nooka, A Chari, A-O Abdallah, N Callander, N Lendvai, D Sborov, A Suvannasankha, K Weisel, L Karlin, E Libby, B Arnulf, T Facon, C Hulin, KM Kortüm, P Rodríguez-Otero, SZ Usmani, P Hari, R Baz, H Quach, P Moreau, PM Voorhees, I Gupta, A Hoos, E Zhi, J Baron, T Piontek, E Lewis, RC Jewell, EJ Dettman, R Popat, S Degli Esposti, J Opalinska, P Richardson, AD Cohen. Single-agent Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma: Results of the Pivotal Phase II Randomised DREAMM-2 Study. Lancet Oncol. 2020;21(7):207-221 DOI: https://doi.org/10.1016/S1470-2045(19)30788-0 PMID: 31859245

Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante SA, Gorsh B, Willson J, Kapetanakis V. DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Adv Ther. 2021 Nov;38(11):5501-5518. doi: 10.1007/s12325-021-01884-7. Epub 2021 Sep 24.

Nooka AK, Cohen AD, Lee HC, Badros A, Suvannasankha A, Callander N, Abdallah AO, Trudel S, Chari A, Libby EN, Chaudhry M, Hultcrantz M, Kortum KM, Popat R, Sborov D, Hakim S, Lewis E, Gorsh B, Bhushan B, McKeown A, Gupta I, Opalinska J, Richardson PG, Lonial S. Single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM-2 trial. Cancer. 2023 Dec 1;129(23):3746-3760. doi: 10.1002/cncr.34987. Epub 2023 Aug 25.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.

Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.

Lonial S, Nooka AK, Thulasi P, Badros AZ, Jeng BH, Callander NS, Potter HA, Sborov D, Zaugg BE, Popat R, Degli Esposti S, Byrne J, Opalinska J, Baron J, Piontek T, Gupta I, Dana R, Farooq AV, Colby K, Jakubowiak A. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J. 2021 May 26;11(5):103. doi: 10.1038/s41408-021-00494-4.

Farooq AV, Degli Esposti S, Popat R, Thulasi P, Lonial S, Nooka AK, Jakubowiak A, Sborov D, Zaugg BE, Badros AZ, Jeng BH, Callander NS, Opalinska J, Baron J, Piontek T, Byrne J, Gupta I, Colby K. Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Ophthalmol Ther. 2020 Dec;9(4):889-911. doi: 10.1007/s40123-020-00280-8. Epub 2020 Jul 25. Erratum In: Ophthalmol Ther. 2020 Sep 12;:

Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03525678
• Other Study ID Numbers: 205678; 2017-004810-25 ( EudraCT Number )
• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Results First Submitted: April 10, 2020
• Results First Posted: April 28, 2020
• Last Update Posted: January 9, 2024