Table 2.

Schedule of study assessments

Assessments	Screening period		Treatment period (1 cycle = 28 days)			End of treatment	Follow-up period
	–28 days	–14 days	Day 1	Day 8	Day 15
Demographics/ Medical history	●
Vital signs, ECOG- PS, body weight		●	●	◎	●	●	○
Adverse event assessment		●	●	◎	●	●	○
Hematology/ Serum chemistry		●	●	◎	●	●	○
Urinalysis		●	●	◎	●	●	○
Tumor marker	●		Every 6 weeks (± 2 weeks)*1			○*2	○*3
Imaging test	●		Every 6 weeks (± 2 weeks)*1			○*2	○*3

●: Mandatory, ◎: Mandatory in first cycle, ○: As required

ECOG-PS: Eastern Cooperative Oncology Group performance score

^*1 : After the first 3 months, the following modified schedule is allowed; every 8 weeks (± 2 weeks) from 3 to 12 month and every 12 weeks (± 2 weeks) thereafter.

^*2 : If the study is discontinued for reasons other than disease progression, it is advisable to perform the assessment.

^*3 : If the study is discontinued for reasons other than disease progression, measurements should be performed every 6 weeks (±2 weeks) until disease progression or the start of new anticancer therapy.