Supplemental Table 2. Baseline Case Report Form (CRF)
Date of enrolment ___ . ___ . ______(dd.mm.yyyy)
Written consent Yes / No
Are the Principles of enrolment into TOP met and the patient characteristics in accordance with the TYSABRI® prescribing information/Product Monograph? Yes / No
Is the patient enrolled in TYGRIS ? Yes / No If yes, patient ID in TYGRIS ______
Is the patient enrolled in other Biogen Idec studies ? Yes / No
Protocol name ______
Protocol number ______
Demographics
Gender M / F
Birth Date ___ . ___ . ______(dd.mm.yyyy)
Patient initials ______
Medical History
Does the patient have a history of Serious Opportunistic Infection? Yes / No
If yes, please specify ______
Does the patient have a malignancy or a history of malignancy? Yes / No
If yes, please specify:
- Breast Cervical
- Colorectal Leukemia
- Lung Lymphoma
- Melanoma Non-melanoma skin cancer
- Prostate Uterine
- Other please specify, ______
- Primary site of malignancy unknown
Does the patient have a history of organ transplant (excluding corneal
transplant)? Yes / No If yes, please specify ______
Date of first MS symptoms ___. ___ . ______(dd.mm.yyyy)
Date of first dose of TYSABRI __ . ___ . ______(dd.mm.yyyy)
Number of doses administered before enrolment in TOP ______
MRI
Was the recommended Baseline MRI performed (within 180 days prior to the initiation of Tysabri)? Yes / No
If yes, Date of most recent MRI before enrolment in TOP? ___ . ___ . ______(dd.mm.yyyy)
Gadolinuim Administration Yes / No If yes T1 + Gd enhancing lesions 0 / 1+
T2 hyperintensive lesions 0 / 1-2 / 3-8 / 9+
If available: Infratentorial lesions 0 / 1+
Juxtacortical lesions 0 / 1+
Periventricular lesions 0 / 1-2 / 3+
History of Disease Modifying Therapies
Does the patient have a history of disease-modifying, anti-neoplastic, or immunosuppressive medications, or steroids? Yes / No
Please enter all the treatments that were initiated before enrolment in TOP:
Treatment Start date End date
______
______
______
History of EDSS
Date of last EDSS before enrolment in TOP: ___ . ___ . ______(dd.mm.yyyy)
Score of last EDSS before enrolment in TOP: ______
EDSS at enrolment visit
Was an EDSS performed at this visit? Yes / No
Pyramidal ______
Cerebellar ______
Brainstem ______
Sensory ______
Bowel/Bladder ______
Visual ______
Mental ______
Ambulation score ______
EDSS score ______
History of relapses
Has the patient experienced relapses between Start date of TYSABRI and Date of enrolment in TOP? Yes / No
Number of relapses in the last year before start of TYSABRI ______
Number of relapses resulting in steroid treatment ______
Number of relapses resulting in hospitalization ______
Number of relapses in the last 2 years before start of TYSABRI ______
Number of relapses resulting in steroid treatment ______
Number of relapses resulting in hospitalization ______
JCV Test*
Has the patient ever been tested for the presence of anti-JCV
antibodies? Yes/No If Yes Date of most recent JCV test ___ . ______
Has the patient ever been tested positive for the presence of anti-JCV antibodies? Yes/No
If Yes Date tested positive ___ . ______
Pregnancy
Is the patient currently pregnant? Yes / No. If Yes, the patient should be reported to Biogen Idec's Drug Safety and Risk Management for registration and follow-up in the TYSABRI® Pregnancy Registry.
* Data concerning the patient’s anti-JCV antibody status was included the version 3.0 of the CRF, following a protocol amendment end of 2012. This data is therefore unavailable for the current analysis.