Visits | Enrollment and Randomization | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | M10 | M11 | M12 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Identification | X | ||||||||||||
Screen by inclusion/exclusion criteria | X | ||||||||||||
Informed consent form | X | ||||||||||||
Initial assessment (history/physical/laboratory/imaging) | X | ||||||||||||
Assessment – History/physical | X | X | X | X | X | X | X | X | X | X | X | X | X |
CT/MRI | X | X | X | X | X | X | X | X | X | X | X | X | X |
Laboratory tests | X | X | X | X | X | X | X | X | X | X | X | X | X |
Quality of life questionnaires | X | X | X | X | X | X | X | X | X | X | X | X | X |
Overall survival | X | X | X | X | X | X | X | X | X | X | X | X | |
Tumor progression Assessment | X | X | X | X | X | X | X | X | X | X | X | X | |
Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X | X |
AEs/SAEs | X | X | X | X | X | X | X | X | X | X | X | X |