Informed consent obtained
|
×
| | | | | | | | | | | |
Inclusion/exclusion criteria assessments
|
×
| | | | | | | | | | | |
History taking
|
×
| | | | | | | | | | | |
Physical examination
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
ECOG status
|
×
| | | | | | | | | | | |
Electrocardiogram
|
×
| | | | | | | | | | | |
Lab test for complete blood count
|
×
| | |
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Lab test for fasting blood glucose
|
×
| | | | | | | | | | | |
Other lab tests(a)
|
×
| | |
×
|
×
| |
×
| |
×
| |
×
|
×
|
Circulating tumor cells
| |
×(b)
|
×(b)
|
×
| |
×
| |
×
| |
×
| | |
Biobank collection
|
×
| | | |
×
| |
×
| |
×
| |
×
|
×
|
Urine analysis(c)
|
×
| | |
×
|
×
| |
×
| |
×
| |
×
|
×
|
Stool examination
|
×
| | | | | | | | | | |
×
|
Pharmacokinetic study(d), (e)
| |
×
|
×
| | | | | | | | | |
Pain score & Quality of life
| |
×
| | |
×
| |
×
| |
×
| |
×
|
×
|
Review of concomitant medications
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Monitoring for adverse events
| | |
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
Tumor assessment(f)
|
×
| | | | | |
×
| | | |
×
| |