Data to be collected | Study Enrollment (Screening) | Baseline (Study Entry) | Data Collection (approximately every ~ 6 months) | Study Completion/ Study Withdrawal |
---|---|---|---|---|
Patient demographics | X | |||
Informed consent | X | |||
Inclusion/exclusion criteria | X | |||
Vital signs and measurementsa | X | X | X | |
Pregnancy status (patient-reported) | X | X | X | |
Pregnancies | whenever they occur | |||
Laboratory test resultsb | X | X | X | |
John Cunningham Virus (JCV) antibody status / index | X | |||
MS disease historyc | X | |||
MS treatment historyd | X | |||
Medical history and comorbidities | X | |||
Clinically significant medical and surgical history (including previous malignancies and precancerous lesions) | X | |||
Malignancy risk factor informatione | X | |||
Cancer screeningf | X | X | X | |
MS symptomsg | X | X | X | |
Current MS DMT administration informationh | X | X | X | |
Patient Reported Outcomes (PROs): Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4, Multiple Sclerosis Impact Scale (MSIS)-29v2, adapted Clinical Global Impression (CGI), Symbol Digit Modality Test (SDMT) | X | X | X | |
Pharmacoeconomic outcomes: Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS) | X | X | X | |
Premature termination incl. Reasons for study withdrawal | X | |||
Continuation of therapy or reasons for treatment discontinuation | X | X | ||
Prior and concomitant medications other than MS medication (up to 3 months prior to study entry) | X | X | X | |
Any malignanciesi | whenever they occur | |||
All serious and non-serious AEs incl. Non-melanoma skin cancer (NMSCs) and information on reasons for death | whenever they occur | |||
Death information | X | X |