ToGA Study - A Study of Herceptin (Trastuzumab) in Combin... | NCT01041404

NCT01041404

Status Module

Name	Class
Chugai Pharmaceutical	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trastuzumab, Fluoropyrimidine, Cisplatin	Experimental	Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.	Drug: Trastuzumab Drug: Fluorouracil Drug: Cisplatin Drug: Capecitabine
Fluoropyrimidine, Cisplatin	Active Comparator	Participants received 800 milligrams per square meter (mg/m2) fluorouracil intravenous (i.v.) on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine orally (p.o.) twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.	Drug: Fluorouracil Drug: Cisplatin Drug: Capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab	Drug	Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression	Trastuzumab, Fluoropyrimidine, Cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) - Percentage of Participants With an Event	OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.	Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
Overall Survival - Time to Event	The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.	BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) - Percentage of Participants With an Event	PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25038874	Derived	Van Cutsem E, Bang YJ, Feng-Yi F, Xu JM, Lee KW, Jiao SC, Chong JL, Lopez-Sanchez RI, Price T, Gladkov O, Stoss O, Hill J, Ng V, Lehle M, Thomas M, Kiermaier A, Ruschoff J. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015 Jul;18(3):476-84. doi: 10.1007/s10120-014-0402-y. Epub 2014 Jul 20.
24951609

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fluoropyrimidine/Cisplatin (FP)	Participants received fluoropyrimidine (EITHER 5-fluorouracil [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 milligrams per square meter (mg/m^2), intravenously (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, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00062.8 OG00156.8

Secondary

Progression-Free Survival (PFS) - Percentage of Participants With an Event

PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Progression-Free Survival - Time to Event

The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

Posted

Median

95% Confidence Interval

months

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

ID	Title	Description
OG000	Fluoropyrimidine, Cisplatin	Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
OG001	Trastuzumab, Fluoropyrimidine, Cisplatin	Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.

Secondary

Time to Progression (TTP) - Percentage of Participants With an Event

TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

FAS

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Progression - Time to Event

The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

FAS

Posted

Median

95% Confidence Interval

months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)

For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Duration of Response - Percentage of Participants With an Event

Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.

FAS; only participants with a CR or PR were included in the analysis.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Duration of Response

The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.

FAS; only participants with a CR or PR were included in the analysis.

Posted

Median

95% Confidence Interval

months

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With Clinical Benefit

Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Overall Survival - Time to Event

The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

Posted

Median

95% Confidence Interval

months

BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis

ID	Title	Description
OG000	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.
OG001	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.

Secondary

European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.

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

Posted

Mean

Standard Error

scores on a scale

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

ID	Title	Description
OG000	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.
OG001	Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

Secondary

EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores

The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.

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

Posted

Mean

Standard Error

scores on a scale

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

ID	Title	Description
OG000	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.
OG001

Secondary

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

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.

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

Posted

Mean

Standard Error

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With a Change in Analgesic Medication During the Study

Analgesic medications were recorded throughout the study until disease progression.

FAS

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Body Weight (Kilograms [kg]) at BL

FAS

Posted

Median

Full Range

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight

Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.

FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Steady State Trastuzumab Area Under the Concentration (AUC)

Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.

Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.

Posted

Median

90% Confidence Interval

mg*day/L

Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Trastuzumab Minimum Serum Concentration (Cmin)

Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.

PK Population

Posted

Median

90% Confidence Interval

mg/L

Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Trastuzumab Maximum Serum Concentration (Cmax)

Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.

PK Population

Posted

Median

90% Confidence Interval

mg/L

Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			81	290	279	290
EG001	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.			106	294	286	294

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected290 at risk EG00118 affected294 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0018 affected294 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0019 affected294 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected290 at risk EG0013 affected294 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0011 affected294 at risk
Gastrointestinal haemorrage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0013 affected294 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Enteritis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0012 affected294 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0010 affected294 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Peritonitus	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0010 affected294 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
lleus paralytic	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0008 affected290 at risk EG00111 affected294 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0007 affected290 at risk EG0014 affected294 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0013 affected294 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0010 affected294 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0016 affected294 at risk
Septic shock	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0005 affected290 at risk EG0011 affected294 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0013 affected294 at risk
Infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Biliary sepsis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Escherichia infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Fungaemia	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pneumococcal infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Tuberculosis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Asthenia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0013 affected294 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0012 affected294 at risk
Pyrexia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0016 affected294 at risk
Death	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0014 affected294 at risk
Chest pain	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Fatigue	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Ill-defined disorder	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected290 at risk EG0017 affected294 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0015 affected294 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Gout	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0013 affected294 at risk
Cerebral infarcation	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Cerebral disorder	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Convulsion	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Lethargy	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected290 at risk EG0013 affected294 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0012 affected294 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Venous thrombosis	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0013 affected294 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0011 affected294 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0010 affected294 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Angina unstable	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Weight decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Blood bilirubin increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Blood pressure decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Ejection fraction decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0011 affected294 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Device migration	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Stent occlusion	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected290 at risk EG0010 affected294 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Completed suicide	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0011 affected294 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0012 affected294 at risk
Arthritis infective	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected290 at risk EG0010 affected294 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG0011 affected294 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG000189 affected290 at risk EG001200 affected294 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG000135 affected290 at risk EG001146 affected294 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00082 affected290 at risk EG001102 affected294 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00095 affected290 at risk EG00176 affected294 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00045 affected290 at risk EG00173 affected294 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00041 affected290 at risk EG00145 affected294 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00021 affected290 at risk EG00132 affected294 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00017 affected290 at risk EG00120 affected294 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00011 affected290 at risk EG00117 affected294 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG000164 affected290 at risk EG001157 affected294 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG00063 affected290 at risk EG00183 affected294 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG00034 affected290 at risk EG00147 affected294 at risk
Fatigue	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00086 affected290 at risk EG001106 affected294 at risk
Asthenia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00053 affected290 at risk EG00159 affected294 at risk
Pyrexia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00036 affected290 at risk EG00153 affected294 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00015 affected290 at risk EG00139 affected294 at risk
Oedema	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00026 affected290 at risk EG00125 affected294 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00013 affected290 at risk EG00118 affected294 at risk
Chills	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected290 at risk EG00123 affected294 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG000137 affected290 at risk EG001138 affected294 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG00014 affected290 at risk EG00121 affected294 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG00011 affected290 at risk EG00115 affected294 at risk
Palmer-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00066 affected290 at risk EG00178 affected294 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00030 affected290 at risk EG00136 affected294 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00017 affected290 at risk EG00119 affected294 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00013 affected290 at risk EG00117 affected294 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG00029 affected290 at risk EG00131 affected294 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG00027 affected290 at risk EG00128 affected294 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG00025 affected290 at risk EG00126 affected294 at risk
Dysgeusia	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG00016 affected290 at risk EG00128 affected294 at risk
Headache	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG00020 affected290 at risk EG00115 affected294 at risk
Weight decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG00040 affected290 at risk EG00168 affected294 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG00019 affected290 at risk EG00124 affected294 at risk
Weight increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG00015 affected290 at risk EG00121 affected294 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00029 affected290 at risk EG00135 affected294 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00017 affected290 at risk EG00122 affected294 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00019 affected290 at risk EG00111 affected294 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00010 affected290 at risk EG00115 affected294 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG00038 affected290 at risk EG00146 affected294 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG00012 affected290 at risk EG00118 affected294 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG00017 affected290 at risk EG00140 affected294 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG00022 affected290 at risk EG00127 affected294 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00015 affected290 at risk EG00115 affected294 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

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.

Facility	Status	City	State	ZIP	Country	Contacts
		Adelaide		5011	Australia

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D000068878	Trastuzumab
D005472	Fluorouracil
D002945	Cisplatin
D000069287	Capecitabine