NCT01041404 · OUTCOME

Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer · Source last updated 2014-11-05

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

Measure: MEAN
Unit: mm
Interval / dispersion: Standard Error
Time frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

What was measured

The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.

Analysis population: FAS; n = number of participants assessed for a specific parameter at a given visit.

Groups in this outcome

Fluoropyrimidine/Cisplatin (FP)

Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.

Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.

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
Fluoropyrimidine/Cisplatin (FP)	290
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	294

Reported measurements

BL (n=275,284)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	21.1	1.42	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	17.9	1.25	Not reported	Not reported	Not reported

Week 4 (n=234,249)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	14.6	1.17	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	13.3	1.11	Not reported	Not reported	Not reported

Week 7 (n=181,219)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	11.1	1.15	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	13.8	1.31	Not reported	Not reported	Not reported

Week 10 (n=174, 202)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	14.5	1.46	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.9	1.30	Not reported	Not reported	Not reported

Week 13 (n=152,181)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	11.3	1.37	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.2	1.35	Not reported	Not reported	Not reported

Week 16 (n=121,165)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	14.0	1.77	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.8	1.53	Not reported	Not reported	Not reported

Week 19 (n=114,142)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	15.4	1.92	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.0	1.43	Not reported	Not reported	Not reported

Week 22 (n=79,141)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	13.3	2.20	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	15.1	1.81	Not reported	Not reported	Not reported

Week 25 (n=64,124)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	12.7	2.39	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	11.0	1.50	Not reported	Not reported	Not reported

Week 28 (n=47,111)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	8.6	1.85	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.3	1.80	Not reported	Not reported	Not reported

Week 31 (n=45,95)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	8.7	2.11	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.5	1.92	Not reported	Not reported	Not reported

Week 34 (n=37,86)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	9.4	2.90	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	10.7	1.79	Not reported	Not reported	Not reported

Week 37 (n=29,64)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	15.5	4.08	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	10.9	2.22	Not reported	Not reported	Not reported

Week 40 (n=24,54)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	16.4	4.20	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	8.8	1.99	Not reported	Not reported	Not reported

Week 43 (n=12,43)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	12.6	5.04	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.2	2.15	Not reported	Not reported	Not reported

Week 46 (n=14,41)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	16.1	6.11	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.4	2.30	Not reported	Not reported	Not reported

Week 49 (n=10,36)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	7.2	3.71	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.5	2.09	Not reported	Not reported	Not reported

Week 52 (n=8,30)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	5.8	3.43	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.9	2.75	Not reported	Not reported	Not reported

Week 55 (n=6,24)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	2.3	1.20	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	3.3	1.48	Not reported	Not reported	Not reported

Week 58 (n=6,20)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	4.7	2.20	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	3.8	1.91	Not reported	Not reported	Not reported

Week 61 (n=4,17)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	5.3	3.04	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.2	5.03	Not reported	Not reported	Not reported

Week 64 (n=3,20)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	2.0	1.00	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.8	3.14	Not reported	Not reported	Not reported

Week 67 (n=4,17)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.5	0.96	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	8.9	5.04	Not reported	Not reported	Not reported

Week 70 (n=3,13)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.3	1.33	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	1.3	1.15	Not reported	Not reported	Not reported

Week 73 (n=3,10)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.0	0.58	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	16.5	8.30	Not reported	Not reported	Not reported

Week 76 (n=3,8)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.7	0.88	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	12.9	11.12	Not reported	Not reported	Not reported

Week 79 (n=3,9)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.0	0.58	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.9	3.89	Not reported	Not reported	Not reported

Week 82 (n=2,6)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	0.00	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	4.8	4.83	Not reported	Not reported	Not reported

Week 85 (n=2,6)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	1.0	1.00	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.3	6.14	Not reported	Not reported	Not reported

Week 88 (n=2,6)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.5	0.50	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.7	5.47	Not reported	Not reported	Not reported

Week 91 (n=2,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.5	0.50	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.5	6.85	Not reported	Not reported	Not reported

Week 94 (n=2,6)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.5	0.50	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.8	5.83	Not reported	Not reported	Not reported

Week 97 (n=1,5)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	0.2	0.20	Not reported	Not reported	Not reported

Week 100 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	0.3	.25	Not reported	Not reported	Not reported

Week 103 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.5	5.85	Not reported	Not reported	Not reported

Week 106 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.8	6.79	Not reported	Not reported	Not reported

Week 109 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.3	7.25	Not reported	Not reported	Not reported

Week 112 (n=1,5)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	4.2	3.50	Not reported	Not reported	Not reported

Week 115 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.8	5.11	Not reported	Not reported	Not reported

Week 118 (n=1,5)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	3.8	3.32	Not reported	Not reported	Not reported

Week 121 (n=1,5)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	3.2	3.20	Not reported	Not reported	Not reported

Week 124 (n=1,4)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	4.5	3.84	Not reported	Not reported	Not reported

Week 127 (n=1,3)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.3	6.33	Not reported	Not reported	Not reported

Week 130 (n=0,3)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	NA	NA	Not reported	Not reported	No participants were analyzed in this treatment group for this timepoint.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.7	5.67	Not reported	Not reported	Not reported

Week 133 (n=1,3)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	0.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	5.0	5.00	Not reported	Not reported	Not reported

Week 136 (n=0,2)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	NA	NA	Not reported	Not reported	No participants were analyzed in this treatment group for this timepoint.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	6.0	6.00	Not reported	Not reported	Not reported

Week 139 (n=0,2)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	NA	NA	Not reported	Not reported	No participants were analyzed in this treatment group for this timepoint.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	8.0	8.00	Not reported	Not reported	Not reported

Week 142 (n=0,2)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	NA	NA	Not reported	Not reported	No participants were analyzed in this treatment group for this timepoint.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	7.5	7.50	Not reported	Not reported	Not reported

Week 145 (n=0,1)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	NA	NA	Not reported	Not reported	No participants were analyzed in this treatment group for this timepoint.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	15.0	NA	Not reported	Not reported	Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.

Final visit/withdrawal (n=157,161)

Values in mm · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fluoropyrimidine/Cisplatin (FP)	23.8	1.99	Not reported	Not reported	Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)	21.9	2.18	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.42
value
21.1
group Id
OG001
spread
1.25
value
17.9
title
BL (n=275,284)
categories
measurements
group Id
OG000
spread
1.17
value
14.6
group Id
OG001
spread
1.11
value
13.3
title
Week 4 (n=234,249)
categories
measurements
group Id
OG000
spread
1.15
value
11.1
group Id
OG001
spread
1.31
value
13.8
title
Week 7 (n=181,219)
categories
measurements
group Id
OG000
spread
1.46
value
14.5
group Id
OG001
spread
1.30
value
12.9
title
Week 10 (n=174, 202)
categories
measurements
group Id
OG000
spread
1.37
value
11.3
group Id
OG001
spread
1.35
value
12.2
title
Week 13 (n=152,181)
categories
measurements
group Id
OG000
spread
1.77
value
14.0
group Id
OG001
spread
1.53
value
12.8
title
Week 16 (n=121,165)
categories
measurements
group Id
OG000
spread
1.92
value
15.4
group Id
OG001
spread
1.43
value
12.0
title
Week 19 (n=114,142)
categories
measurements
group Id
OG000
spread
2.20
value
13.3
group Id
OG001
spread
1.81
value
15.1
title
Week 22 (n=79,141)
categories
measurements
group Id
OG000
spread
2.39
value
12.7
group Id
OG001
spread
1.50
value
11.0
title
Week 25 (n=64,124)
categories
measurements
group Id
OG000
spread
1.85
value
8.6
group Id
OG001
spread
1.80
value
12.3
title
Week 28 (n=47,111)
categories
measurements
group Id
OG000
spread
2.11
value
8.7
group Id
OG001
spread
1.92
value
12.5
title
Week 31 (n=45,95)
categories
measurements
group Id
OG000
spread
2.90
value
9.4
group Id
OG001
spread
1.79
value
10.7
title
Week 34 (n=37,86)

denoms

counts
group Id
OG000
value
290
group Id
OG001
value
294
units
Participants

description

dispersion Type

Standard Error

groups

description
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
id
OG000
title
Fluoropyrimidine/Cisplatin (FP)
description
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
id
OG001
title
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

param Type

MEAN

population Description

FAS; n = number of participants assessed for a specific parameter at a given visit.

reporting Status

POSTED

time Frame

BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

title

Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)

type

SECONDARY

unit Of Measure

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Preserved source evidence · Not medical advice