Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Pl... | NCT02322593

Name	Class
Yakult Honsha Co., LTD	INDUSTRY

Label	Type	Description	Intervention Names
TAS-118/Oxaliplatin	Experimental	TAS-118 plus Oxaliplatin	Drug: TAS-118 plus Oxaliplatin
S-1/Cisplatin	Active Comparator	S-1 plus Cisplatin	Drug: S-1 plus Cisplatin

Name	Type	Description	Arm Group Labels	Other Names
TAS-118 plus Oxaliplatin	Drug		TAS-118/Oxaliplatin
S-1 plus Cisplatin

Measure	Description	Time Frame
Overall Survival	The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.	A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.

Measure	Description	Time Frame
Progression-free Survival	PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.	A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.

Facility	Status	City	State	ZIP	Country	Contacts
Taiho Pharmaceutical Co., Ltd selected site		Ibaraki		305-8576	Japan
Taiho Pharmaceutical Co., Ltd selected site

PubMed Identifier	Type	Citation	Retractions
32682457	Derived	Kang YK, Chin K, Chung HC, Kadowaki S, Oh SC, Nakayama N, Lee KW, Hara H, Chung IJ, Tsuda M, Park SH, Hosaka H, Hironaka S, Miyata Y, Ryu MH, Baba H, Hyodo I, Bang YJ, Boku N. S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Aug;21(8):1045-1056. doi: 10.1016/S1470-2045(20)30315-6. Epub 2020 Jul 16.

ID	Title	Description
FG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 7, 2019	Aug 24, 2021

ID	Title	Description
BG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
BG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000347 BG001334 BG002681

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival

The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.

Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.

Posted

Median

95% Confidence Interval

Months

A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.

ID	Title	Description
OG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
OG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Units	Counts
Participants	OG000347 OG001334

Title

Denominators

Categories

Title	Measurements
	OG00016.0(13.8 to 18.3) OG00115.1(13.6 to 16.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Log Rank		0.039		Hazard Ratio (HR)	0.83	Standard Error of the Mean	0.091	2-Sided	95	0.69	0.99					Superiority

Secondary

Progression-free Survival

PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.

FAS

Posted

Median

95% Confidence Interval

Months

A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.

ID	Title	Description
OG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
OG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Secondary

Time to Treatment Failure

TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier.

Posted

Median

95% Confidence Interval

Months

From the date of randomization to the date of the last administration of the study drug.

ID	Title	Description
OG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
OG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Units	Counts

Secondary

Overall Response Rate

ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions

Tumor Response (TR) Evaluable Population： Patients in FAS population presenting measurable lesions (at least one target lesion), evaluated for tumor responses at least once during treatment with the study drug.

Posted

Count of Participants

Participants

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.

ID	Title	Description
OG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
OG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Secondary

Disease Control Rate

DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.

TR Evaluable Population：

Posted

Count of Participants

Participants

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.

ID	Title	Description
OG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
OG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0015 affected348 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0010 affected348 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0004 affected352 at risk EG0016 affected348 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Prinzmetal angina	Cardiac disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0013 affected348 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00010 affected352 at risk EG0019 affected348 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Ascites	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0005 affected352 at risk EG0018 affected348 at risk
Cheilitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Colitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00014 affected352 at risk EG0018 affected348 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Enteritis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0005 affected352 at risk EG0012 affected348 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0010 affected348 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0012 affected348 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0013 affected348 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Ileus	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0007 affected352 at risk EG0015 affected348 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Nausea	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00011 affected352 at risk EG0016 affected348 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0018 affected348 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Rectal stenosis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0013 affected348 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Vomiting	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0004 affected352 at risk EG0011 affected348 at risk
Oesophageal discomfort	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Gastric stenosis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0014 affected348 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Asthenia	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0004 affected352 at risk EG0012 affected348 at risk
Condition aggravated	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Death	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Fatigue	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0014 affected348 at risk
Malaise	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0012 affected348 at risk
Mucosal inflammation	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Mucous membrane disorder	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Oedema peripheral	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Pain	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Pyrexia	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00010 affected352 at risk EG0015 affected348 at risk
Disease progression	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0005 affected352 at risk EG0011 affected348 at risk
Complication associated with device	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0012 affected348 at risk
Jaundice	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0011 affected348 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Appendicitis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Atypical pneumonia	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Dacryocystitis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Diverticulitis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Infection	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Influenza	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Peritonitis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Pneumonia	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0008 affected352 at risk EG0017 affected348 at risk
Pneumonia herpes viral	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Sepsis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0012 affected348 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Urethritis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Urinary tract infection	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0004 affected352 at risk EG0011 affected348 at risk
Cytomegalovirus enterocolitis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Cytomegalovirus enteritis	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Enterocolitis infectious	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Enteritis infectious	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Lung infection	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0013 affected348 at risk
Biliary tract infection	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Alanine aminotransferase increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Blood bilirubin increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Neutrophil count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0016 affected348 at risk
Platelet count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Weight decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
White blood cell count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0005 affected352 at risk EG0016 affected348 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00039 affected352 at risk EG00132 affected348 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0013 affected348 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0012 affected348 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0013 affected348 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0005 affected352 at risk EG0011 affected348 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0011 affected348 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Cerebral infarction	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Dementia	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Dizziness	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Dysarthria	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Headache	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Loss of consciousness	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Presyncope	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Seizure	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Status epilepticus	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Syncope	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Partial seizures	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Delirium	Psychiatric disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Suicide attempt	Psychiatric disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Mental disorder	Psychiatric disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0004 affected352 at risk EG0018 affected348 at risk
Renal disorder	Renal and urinary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Renal impairment	Renal and urinary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Adnexal torsion	Reproductive system and breast disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0013 affected348 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0002 affected352 at risk EG0010 affected348 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0012 affected348 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0003 affected352 at risk EG0014 affected348 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0011 affected348 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk
Embolism	Vascular disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0000 affected352 at risk EG0012 affected348 at risk
Infarction	Vascular disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0001 affected352 at risk EG0010 affected348 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00094 affected352 at risk EG00196 affected348 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00014 affected352 at risk EG00119 affected348 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00050 affected352 at risk EG00153 affected348 at risk
Lacrimation increased	Eye disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00041 affected352 at risk EG00137 affected348 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00046 affected352 at risk EG00130 affected348 at risk
Constipation	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00080 affected352 at risk EG00190 affected348 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000189 affected352 at risk EG001134 affected348 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00020 affected352 at risk EG00113 affected348 at risk
Nausea	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000200 affected352 at risk EG001186 affected348 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000148 affected352 at risk EG00188 affected348 at risk
Vomiting	Gastrointestinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000100 affected352 at risk EG00170 affected348 at risk
Fatigue	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000116 affected352 at risk EG001106 affected348 at risk
Malaise	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00077 affected352 at risk EG00176 affected348 at risk
Oedema	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0009 affected352 at risk EG00126 affected348 at risk
Oedema peripheral	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00021 affected352 at risk EG00127 affected348 at risk
Pyrexia	General disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00045 affected352 at risk EG00132 affected348 at risk
Alanine aminotransferase increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00045 affected352 at risk EG00120 affected348 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00050 affected352 at risk EG00119 affected348 at risk
Blood creatinine increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG0006 affected352 at risk EG00133 affected348 at risk
Neutrophil count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00090 affected352 at risk EG001115 affected348 at risk
Platelet count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG000103 affected352 at risk EG00176 affected348 at risk
Weight decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00078 affected352 at risk EG00141 affected348 at risk
White blood cell count decreased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00045 affected352 at risk EG00176 affected348 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (ver. 21.0)	Systematic Assessment	EG00027 affected352 at risk EG00110 affected348 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00040 affected352 at risk EG00125 affected348 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00019 affected352 at risk EG00114 affected348 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG0007 affected352 at risk EG00119 affected348 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000234 affected352 at risk EG001216 affected348 at risk
Dizziness	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00018 affected352 at risk EG00134 affected348 at risk
Dysgeusia	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000112 affected352 at risk EG00182 affected348 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00021 affected352 at risk EG0017 affected348 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG000242 affected352 at risk EG00154 affected348 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00019 affected352 at risk EG00162 affected348 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00011 affected352 at risk EG00123 affected348 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00060 affected352 at risk EG00127 affected348 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00018 affected352 at risk EG00119 affected348 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00063 affected352 at risk EG00150 affected348 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00032 affected352 at risk EG00117 affected348 at risk
Vascular pain	Vascular disorders	MedDRA (ver. 21.0)	Systematic Assessment	EG00032 affected352 at risk EG0019 affected348 at risk

ID	Term
D013274	Stomach Neoplasms
D005767	Gastrointestinal Diseases
D005770	Gastrointestinal Neoplasms

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

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	22	352	155	352	344	352
EG001	S-1/Cisplatin	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	8	348	159	348	328	348