Table 2 Visite schedule

Study week (W)

−4

1–4

9–13

12–17

3–7

6–11

Informed consent^b(Study and translational research)

-4

Medical history incl. smoking and alcohol, demographics

X

Eligibility criteria^a

X

CT or MRI Neck

X

CT Chest/Abdomen

X

Physical examination^b

−2

X

X

X

X

X

Performance status/ASA

−2

X

X

X

X

X

Vital signs^c

−2

X

X

X

X

X

Laboratory determinations^d

X

X

X

X

X

X

Panendoscopy, FFPE tissue^a

X

X^e

Audiometry

X

X

X

Blood draw translat. research^a

X

X

X^j

X

X^j

X

Dental evaluation and panoramic view as indicated

X

Postoperative morbidity^a

X

X

X

X

Swallowing function^{a f}

X

X

X

X

X

X

Nutritional evaluation

X

Quality of life assessment^{a g}

X

X

X

X

X

X

Health Care Utilization and Productivity loss^{a h}

X

Monitoring AE’s/SAE’s^a

Survival