Table 1.
Section | Sub-Section | Description |
---|---|---|
Baseline | Clinical center | Identification |
Patient |
Identification and encryption of personal data
State of Life Record creation date |
|
Onset MS | Date, symptoms, course (including RIS) | |
Diagnosis | Date, Mc Donald Criteria 2010 and 2017 [8, 9] | |
Follow-up (FU) | Visits | Date, EDSS, course |
Relapses | Date, duration, functional systems involved, severity, recovery, steroid treatment | |
Treatments | Start date, end date, dosage, administration routes, disease modifying or symptomatic therapies, discontinuation cause (if applicable) | |
Adverse events | Reporting severe adverse events and adverse events (using MedDRA coding system) | |
Paraclinical tests | Magnetic Resonance Imaging | Date, CNS region, presence and number of T2, T1 and, T1 Gd + lesions, McDonald’s Criteria (2017) for space and time dissemination |
Cerebrospinal fluid | Date, routine, oligoclonal bands (presence/absence) | |
Evoked potentials | Date, visual evoked potentials(VEP), upper and lower somatosensory and motor evoked potentials (SEP and MEP), brainstem auditory evoked potentials (BAEP) | |
Laboratory tests | Date, routine, hematologic, virological, immunological, thyroid function | |
Clinical events | History | Family history, pregnancies, comorbidities |