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NCT03525678 · OUTCOME

Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score

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 · Source last updated 2025-09-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Scores on a scale
Interval / dispersion: Standard Deviation
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

What was measured

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.

Analysis population: 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

Groups in this outcome

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	97
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	25

Reported measurements

FP,Week 07,n=47,45,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	47
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	45
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.8	25.11	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	4.2	29.99	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8.3	24.51	Not reported	Not reported	Not reported

FP,Week 13,n=28,28,15

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	15

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-2.0	24.39	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	8.3	22.55	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-2.2	27.28	Not reported	Not reported	Not reported

FP,Week 19,n=18,25,10

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3.7	22.87	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	10.7	20.91	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3.3	27.24	Not reported	Not reported	Not reported

FP,Week 25,n=19,23,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	19
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	23
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.3	27.11	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13.5	29.39	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4.8	31.98	Not reported	Not reported	Not reported

FP,Week 31,n=14,18,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	7.1	18.80	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	19.1	24.93	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7.9	27.00	Not reported	Not reported	Not reported

FP,Week 37,n=14,13,5

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	5

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	6.3	17.28	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	29.1	22.47	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	11.1	31.43	Not reported	Not reported	Not reported

FP,Week 43,n=15,13,4

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	15
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	8.1	21.19	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	29.9	26.98	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8.3	5.56	Not reported	Not reported	Not reported

FP,Week 61,n=11,11,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	10.1	18.89	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	4.0	20.65	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	25.9	54.81	Not reported	Not reported	Not reported

FP,Week 79,n=3,2,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-7.4	6.42	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	33.3	31.43	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	38.9	39.28	Not reported	Not reported	Not reported

FP,Week 97,n=4,5,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5.6	14.34	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	17.8	39.75	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22.2	40.06	Not reported	Not reported	Not reported

FP,Week 115,n=2,6,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	11.1	15.71	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	16.7	25.09	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	33.3	58.79	Not reported	Not reported	Not reported

FP,Week 133,n=2,1,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	27.8	7.86	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	55.6	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	38.9	55.00	Not reported	Not reported	Not reported

FP,Week 151,n=0,2,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	44.4	15.71	Not reported	Not reported	Not reported

FP,Week 169,n=0,1,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	55.6	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.

FP,Week 186,n=39,46,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	39
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	46
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-9.4	19.34	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-7.7	26.69	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3.5	24.59	Not reported	Not reported	Not reported

BI,Week 07,n=47,45,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	47
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	45
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.8	22.87	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	9.6	28.09	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4.2	43.67	Not reported	Not reported	Not reported

BI,Week 13,n=28,28,15

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	15

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	6.0	25.75	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6.0	35.20	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-4.4	37.52	Not reported	Not reported	Not reported

BI,Week 19,n=18,25,10

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5.6	23.57	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	8.0	25.96	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-3.3	42.89	Not reported	Not reported	Not reported

BI,Week 25,n=19,23,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	19
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	23
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	7.0	23.78	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	15.9	31.57	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	9.5	53.45	Not reported	Not reported	Not reported

BI,Week 31,n=14,18,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.4	20.52	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	14.8	30.73	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	9.5	56.81	Not reported	Not reported	Not reported

BI,Week 37,n=14,13,5

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	5

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	9.5	27.51	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25.6	30.89	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	26.7	54.77	Not reported	Not reported	Not reported

BI,Week 43,n=15,13,4

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	15
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4.4	24.77	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28.2	38.12	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8.3	16.67	Not reported	Not reported	Not reported

BI,Week 61,n=11,11,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	6.1	25.03	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	12.1	26.97	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	33.3	57.74	Not reported	Not reported	Not reported

BI,Week 79,n=3,2,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0.0	0.00	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.0	0.00	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	33.3	94.28	Not reported	Not reported	Not reported

BI,Week 97,n=4,5,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	8.3	31.91	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6.7	27.89	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	44.4	69.39	Not reported	Not reported	Not reported

BI,Week 115,n=2,6,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-16.7	70.71	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5.6	25.09	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	55.6	50.92	Not reported	Not reported	Not reported

BI,Week 133,n=2,1,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	16.7	23.57	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.0	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	83.3	23.57	Not reported	Not reported	Not reported

BI,Week 151,n=0,2,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	16.7	23.57	Not reported	Not reported	Not reported

BI,Week 169,n=0,1,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.0	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.

BI,Week 186,n=39,46,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	39
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	46
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-4.3	30.76	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-0.7	35.48	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10.4	41.67	Not reported	Not reported	Not reported

DS,Week 07,n=47,45,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	47
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	45
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-1.8	19.73	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-1.0	17.78	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-2.8	12.17	Not reported	Not reported	Not reported

DS,Week 13,n=28,28,15

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	15

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-1.0	16.22	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-3.2	22.95	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	1.1	25.65	Not reported	Not reported	Not reported

DS,Week 19,n=18,25,10

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0.9	14.91	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-6.4	17.98	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-1.7	20.63	Not reported	Not reported	Not reported

DS,Week 25,n=19,23,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	19
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	23
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-0.0	16.25	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-3.6	17.78	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-1.6	25.20	Not reported	Not reported	Not reported

DS,Week 31,n=14,18,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-3.6	10.59	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-10.5	19.23	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-4.8	23.88	Not reported	Not reported	Not reported

DS,Week 37,n=14,13,5

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	5

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-6.0	12.22	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-9.8	22.92	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-14.4	16.01	Not reported	Not reported	Not reported

DS,Week 43,n=15,13,4

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	15
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-5.9	12.51	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-14.5	24.06	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-8.3	26.64	Not reported	Not reported	Not reported

DS,Week 61,n=11,11,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-11.6	12.29	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-7.6	10.02	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-11.1	16.67	Not reported	Not reported	Not reported

DS,Week 79,n=3,2,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-16.7	11.11	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-2.8	3.93	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-2.8	27.50	Not reported	Not reported	Not reported

DS,Week 97,n=4,5,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-12.5	15.30	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-3.3	15.52	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-7.4	25.05	Not reported	Not reported	Not reported

DS,Week 115,n=2,6,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-19.4	3.93	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-7.4	10.92	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-10.0	16.59	Not reported	Not reported	Not reported

DS,Week 133,n=2,1,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-13.9	11.79	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-5.6	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	8.3	51.07	Not reported	Not reported	Not reported

DS,Week 151,n=0,2,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5.6	15.71	Not reported	Not reported	Not reported

DS,Week 169,n=0,1,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-5.6	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.

DS,Week 186, n=39,46,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	39
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	46
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-0.6	17.28	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2.5	18.36	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4.9	24.50	Not reported	Not reported	Not reported

SET,Week 07,n=47,45,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	47
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	45
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1.5	9.21	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.4	13.33	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0.2	15.49	Not reported	Not reported	Not reported

SET,Week 13,n=28,28,15

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	28
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	15

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.0	10.44	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-1.7	11.96	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	6.8	23.69	Not reported	Not reported	Not reported

SET,Week 19,n=18,25,10

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	25
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0.0	10.40	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-1.2	10.87	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0.9	9.04	Not reported	Not reported	Not reported

SET,Week 25,n=19,23,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	19
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	23
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3.4	8.41	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.1	13.10	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0.4	6.45	Not reported	Not reported	Not reported

SET,Week 31,n=14,18,7

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	18
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	7

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.0	6.07	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-2.9	13.87	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	5.5	11.12	Not reported	Not reported	Not reported

SET,Week 37,n=14,13,5

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	14
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	5

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2.2	6.91	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-6.0	17.82	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-1.8	4.04	Not reported	Not reported	Not reported

SET,Week 43,n=15,13,4

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	15
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	13
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	4

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	1.0	8.81	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-5.6	19.05	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-4.9	5.76	Not reported	Not reported	Not reported

SET,Week 61,n=11,11,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-2.1	12.32	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1.9	12.82	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2.0	9.84	Not reported	Not reported	Not reported

SET,Week 79,n=3,2,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	3
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5.9	11.40	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	9.1	12.83	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-1.3	4.45	Not reported	Not reported	Not reported

SET,Week 97,n=4,5,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	-0.2	5.42	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	5.0	13.80	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-4.7	3.44	Not reported	Not reported	Not reported

SET,Week 115,n=2,6,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	6
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5.7	13.36	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.7	7.21	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-1.0	7.09	Not reported	Not reported	Not reported

SET,Week 133,n=2,1,2

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	2

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	5.7	13.36	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-7.4	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	-8.1	5.24	Not reported	Not reported	Not reported

SET,Week 151,n=0,2,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	2
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	0.0	15.71	Not reported	Not reported	Not reported

SET,Week 169,n=0,1,0

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	0
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	1
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	0

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	-11.1	NA	Not reported	Not reported	NA indicates SD could not be calculated for a single participant.

SET,Week 186,n=39,46,16

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	39
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	46
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	16

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	4.0	10.98	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	4.0	12.61	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3.7	10.75	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
25.11
value
2.8
group Id
OG001
spread
29.99
value
4.2
group Id
OG002
spread
24.51
value
8.3
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
45
group Id
OG002
value
16
units
Participants
title
FP,Week 07,n=47,45,16
categories
measurements
group Id
OG000
spread
24.39
value
-2.0
group Id
OG001
spread
22.55
value
8.3
group Id
OG002
spread
27.28
value
-2.2
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
28
group Id
OG002
value
15
units
Participants
title
FP,Week 13,n=28,28,15
categories
measurements
group Id
OG000
spread
22.87
value
3.7
group Id
OG001
spread
20.91
value
10.7
group Id
OG002
spread
27.24
value
3.3
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
25
group Id
OG002
value
10
units
Participants
title
FP,Week 19,n=18,25,10
categories
measurements
group Id
OG000
spread
27.11
value
2.3
group Id
OG001
spread
29.39
value
13.5
group Id
OG002
spread
31.98
value
4.8
denoms
counts
group Id
OG000
value
19
group Id
OG001
value
23
group Id
OG002
value
7
units
Participants
title
FP,Week 25,n=19,23,7
categories
measurements
group Id
OG000
spread
18.80
value
7.1
group Id
OG001
spread
24.93
value
19.1
group Id
OG002
spread
27.00
value
7.9
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
18
group Id
OG002
value
7
units
Participants
title
FP,Week 31,n=14,18,7
categories
measurements
group Id
OG000
spread
17.28
value
6.3
group Id
OG001
spread
22.47
value
29.1
group Id
OG002
spread
31.43
value
11.1
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
group Id
OG002
value
5
units
Participants
title
FP,Week 37,n=14,13,5
categories
measurements
group Id
OG000
spread
21.19
value
8.1
group Id
OG001
spread
26.98
value
29.9
group Id
OG002
spread
5.56
value
8.3
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
13
group Id
OG002
value
4
units
Participants
title
FP,Week 43,n=15,13,4
categories
measurements
group Id
OG000
spread
18.89
value
10.1
group Id
OG001
spread
20.65
value
4.0
group Id
OG002
spread
54.81
value
25.9
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
3
units
Participants
title
FP,Week 61,n=11,11,3
categories
measurements
group Id
OG000
spread
6.42
value
-7.4
group Id
OG001
spread
31.43
value
33.3
group Id
OG002
spread
39.28
value
38.9
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
units
Participants
title
FP,Week 79,n=3,2,2
categories
measurements
group Id
OG000
spread
14.34
value
5.6
group Id
OG001
spread
39.75
value
17.8
group Id
OG002
spread
40.06
value
22.2
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
3
units
Participants
title
FP,Week 97,n=4,5,3
categories
measurements
group Id
OG000
spread
15.71
value
11.1
group Id
OG001
spread
25.09
value
16.7
group Id
OG002
spread
58.79
value
33.3
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
6
group Id
OG002
value
3
units
Participants
title
FP,Week 115,n=2,6,3
categories
measurements
group Id
OG000
spread
7.86
value
27.8
comment
NA indicates SD could not be calculated for a single participant.
group Id
OG001
spread
NA
value
55.6
group Id
OG002
spread
55.00
value
38.9
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
2
units
Participants
title
FP,Week 133,n=2,1,2

denoms

counts
group Id
OG000
value
97
group Id
OG001
value
99
group Id
OG002
value
25
units
Participants

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.

dispersion Type

Standard Deviation

groups

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.
id
OG000
title
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
description
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.
id
OG001
title
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
description
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.
id
OG002
title
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

param Type

MEAN

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

reporting Status

POSTED

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

title

Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score

type

SECONDARY

unit Of Measure

Scores on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice