Table 1 Data to be obtained during the PANGAEA main study

Informed consent

X

Patient characteristics

X

Anamnesis (incl. MS)

X

12-channel ECG

X

– additionally before first dose and when restarting fingolimod after treatment interruption –

HR, BP, bradycardia

X

Varicella-zoster status

X

Prev. immunotherapy

X

Concomitant diseases and drugs

X

Impaired lung function

X

Chronic infections

X

HR, BP

X

X

X

X

X

CBC, clin. chemistry

X

X

X

X

X

Ophthalmology

– if required –

X

– if required –

Pregnancy

X

– if required –

Prem. discontinuation

X

– if required –

CGI

X

X

X

X

X

EDSS

X

X

X

X

X

MSFC^a

X

X

X

X

X

SDMT^a

– every 6 months –

MS-relapse

X

X

X

X

MRI-lesions

– if available –

AE

X

X

X

X

SAE

X

X

X

X