Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.

Time frame: From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)

Population: Analysis was performed on the ITT population that included all randomized participants.

Duration of response was defined as the time (in months) from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \<10 mm. Analysis was performed by using Kaplan-Meier method.

Time frame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Population: Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.

An AE was any untoward medical condition that occurred in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication \[maximum duration: 35.7 months\]).

Time frame: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)

Population: Analysis was performed on the as treated (AT) population.

AE was defined as any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily had to have a causal relationship with the use of the study medication. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (from first dose of study medication up to 30 days of last study medication \[maximum duration: 35.7 months\]).

Time frame: From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months)

Population: Analysis was performed on the as treated (AT) population that included all participants who initiated treatment with either of the 2 regimens with treatment assignment designated according to actual treatment received.

ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) based on the Investigator review of the images and application of Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to less than (\<) 10 millimeter (mm). PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.

Time frame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Population: Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.

PFS was defined as the time from date of randomization until date of radiological disease progression or death due to any cause. Disease Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where any of the 3 criteria have been met: 1) at least 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, including the baseline sum, 2) Progression in no-target lesion(s), 3) appearance of new lesion(s) Participants who were alive with no PD were censored at the date of the last tumor assessment. Participants who received new anticancer therapy before disease progression were censored at the date of the last evaluable tumor assessment before new anticancer therapy was initiated. Analysis was performed by using Kaplan-Meier method.

Time frame: From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months)

Population: Analysis was performed on the ITT population.

TTF was defined as the time from date of randomization until date of PD (clinical or radiologic), or permanent discontinuation of study treatment (S-1 or 5-FU), or death due to any cause. Participates who were still on study treatment at the time of the analysis were censored at the last date the participants was known to be on treatment.

Time frame: From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months)

Population: Analysis was performed on the ITT population.

TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \<10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference. Analysis was performed by using Kaplan-Meier method.

Time frame: From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months)

Population: Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.