Table 2 Schedule of Activities (SoA) for patients enrolled in treatment-cohort

Check inclusion criteria and exclusion criteria for treatment phase + Drug specific selection criteria

X

 Informed consent^a

X

 Medical history

X

 Drug dispensing^b

X

X

X

X

X

X

 Physical examination

X

X

X

X

X

X

X

 Vital signs and ECOG PS

X

X

X

X

X

X

X

X

 ECG

X

 AE/SAE assessment

X

X

X

X

X

X

X

 Concomitant medication

X

X

X

X

X

X

X

 QoL (V)

X

X

X

X

X

X

 Laboratory Assessments^c

X

X

X

X

X

X

X

 Pregnancy test^{d, e}

X

Monthly as long as use of contraception is required, see drug specific amendment

Central lab sampling

X

 Plasma/serum samples

X

X

X

X

X

X

X

 Urineⁱ

X

X

X

 Fecesⁱ

X

X

 Tumor biopsy

X

X

X

 Other material^f

X

X

X

X

Tumor assessment

X

X

X

X

X

X

X

Survival follow-up

X