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NCT02064387 · OUTCOME

Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 2 (MM)

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline, Day 1 (Cycle 2, 3, 6, 7, 9, 11, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)

What was measured

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. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.

Analysis population: Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (MM)

Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).

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
Part 2: GSK2857916 3.40 mg/kg (MM)	35

Reported measurements

Baseline, screening, positive, n=30

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	30

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Baseline, screening, negative n=30

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	30

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	28	Not reported	Not reported	Not reported	Not reported

Baseline, confirming, positive, n=2

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Baseline, confirming, negative, n=2

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Baseline, negative, conclusive, n=30

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	30

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	21	Not reported	Not reported	Not reported	Not reported

Cycle 2, Day 1, screening, positive, n=31

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	31

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	3	Not reported	Not reported	Not reported	Not reported

Cycle 2, Day 1, screening, negative, n=31

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	31

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	28	Not reported	Not reported	Not reported	Not reported

Cycle 2, Day 1, confirming, positive, n=3

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 2, Day 1, confirming, negative, n=3

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	3	Not reported	Not reported	Not reported	Not reported

Cycle 2, Day 1, negative, conclusive, n=31

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	31

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	27	Not reported	Not reported	Not reported	Not reported

Cycle 3, Day 1, screening, positive, n=23

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 3, Day 1, screening, negative, n=23

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	23	Not reported	Not reported	Not reported	Not reported

Cycle 3, Day 1, confirming, positive, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 3, Day 1, confirming, negative, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 3, Day 1, negative, conclusive, n=23

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	23

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	14	Not reported	Not reported	Not reported	Not reported

Cycle 6, Day 1, screening, positive, n=17

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	17

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	4	Not reported	Not reported	Not reported	Not reported

Cycle 6, Day 1, screening, negative, n=17

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	17

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	13	Not reported	Not reported	Not reported	Not reported

Cycle 6, Day 1, confirming, positive, n=4

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 6, Day 1, confirming, negative, n=4

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	4	Not reported	Not reported	Not reported	Not reported

Cycle 6, Day 1, negative, conclusive, n=17

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	17

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 7, Day 1, screening, positive, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 7, Day 1, screening, negative, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Cycle 7, Day 1, confirming, positive, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 7, Day 1, confirming, negative, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 7, Day 1, negative, conclusive, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 9, Day 1, screening, positive, n=16

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Cycle 9, Day 1, screening, negative, n=16

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	14	Not reported	Not reported	Not reported	Not reported

Cycle 9, Day 1, confirming, positive, n=2

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 9, Day 1, confirming, negative, n=2

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	2	Not reported	Not reported	Not reported	Not reported

Cycle 9, Day 1, negative, conclusive, n=16

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	16

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 11, Day 1, screening, positive, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 11, Day 1, screening, negative, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

Cycle 11, Day 1, confirming, positive, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 11, Day 1, confirming, negative, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 11, Day 1, negative, conclusive, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 12, Day 1, screening, positive, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 12, Day 1, screening, negative, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	8	Not reported	Not reported	Not reported	Not reported

Cycle 12, Day 1, confirming, positive, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 12, Day 1, confirming, negative, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 12, Day 1, negative, conclusive, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 16, Day 1, screening, positive, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Cycle 16, Day 1, screening, negative, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	8	Not reported	Not reported	Not reported	Not reported

Cycle 16, Day 1, confirming, positive, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 16, Day 1, confirming, negative, n=0

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	0

Cycle 16, Day 1, negative, conclusive, n=8

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

End of study, screening, positive, n=21

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

End of study, screening, negative, n=21

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	20	Not reported	Not reported	Not reported	Not reported

End of study, confirming, positive, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

End of study, confirming, negative, n=1

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	1	Not reported	Not reported	Not reported	Not reported

End of study, negative, conclusive, n=21

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (MM)	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (MM)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
30
units
Participants
title
Baseline, screening, positive, n=30
categories
measurements
group Id
OG000
value
28
denoms
counts
group Id
OG000
value
30
units
Participants
title
Baseline, screening, negative n=30
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
2
units
Participants
title
Baseline, confirming, positive, n=2
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
2
units
Participants
title
Baseline, confirming, negative, n=2
categories
measurements
group Id
OG000
value
21
denoms
counts
group Id
OG000
value
30
units
Participants
title
Baseline, negative, conclusive, n=30
categories
measurements
group Id
OG000
value
3
denoms
counts
group Id
OG000
value
31
units
Participants
title
Cycle 2, Day 1, screening, positive, n=31
categories
measurements
group Id
OG000
value
28
denoms
counts
group Id
OG000
value
31
units
Participants
title
Cycle 2, Day 1, screening, negative, n=31
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
3
units
Participants
title
Cycle 2, Day 1, confirming, positive, n=3
categories
measurements
group Id
OG000
value
3
denoms
counts
group Id
OG000
value
3
units
Participants
title
Cycle 2, Day 1, confirming, negative, n=3
categories
measurements
group Id
OG000
value
27
denoms
counts
group Id
OG000
value
31
units
Participants
title
Cycle 2, Day 1, negative, conclusive, n=31
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
23
units
Participants
title
Cycle 3, Day 1, screening, positive, n=23
categories
measurements
group Id
OG000
value
23
denoms
counts
group Id
OG000
value
23
units
Participants
title
Cycle 3, Day 1, screening, negative, n=23

denoms

counts
group Id
OG000
value
35
units
Participants

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. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.

groups

description
Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
id
OG000
title
Part 2: GSK2857916 3.40 mg/kg (MM)

param Type

COUNT_OF_PARTICIPANTS

population Description

Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

reporting Status

POSTED

time Frame

Baseline, Day 1 (Cycle 2, 3, 6, 7, 9, 11, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)

title

Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 2 (MM)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice