Table 3 Objectives and Outcomes

Primary

Improvement in memory satisfaction from baseline to week 8 when comparing methylprednisolone with placebo in PCS patients

Intra-patient change in MMQ subdomain memory satisfaction by ≥ 15 points from baseline to week 8

Secondary

Long-term improvement in memory satisfaction from baseline to week 20 and to week 52

Intra-patient change in MMQ subdomain “memory satisfaction” from baseline to week 20, from week 8 to week 20 and from week 20 to week 52

Improvement in memory ability, and memory strategy

Mean difference in MMQ subdomain “memory ability” from baseline to week 8 and to week 20 and from week 8 to week 20

Mean difference in MMQ subdomain “memory strategy” to week 8 and to week 20 and from week 8 to week 20

Improvement in neurocognitive symptoms quantified using neuropsychological and cognitive scores

Intra-patient change in neuro-psychological and cognitive scores (MoCA, neuropsychological test battery, SDMT) from baseline to week 8 and to week 20 and from week 8 to week 20

Improvement in quality of life

Intra-patient change in quantified PROMIS questionnaire and SF-36 from baseline to week 8 and to week 20 and to week 52 and from week 8 to week 20

Improvement in fatigue and mood

Intra-patient change in fatigue scores (FSS, CFQ) and mood (BDI) from baseline to week 8 and to week 20 and to week 52 and from week 8 to week 20

Key safety

Infections meeting SAE criteria

Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports

Psychiatric complications (depression, euphoria, severe sleep disorders)

Endocrinologic disorders meeting SAE criteria

Exploratory

Biomarker-related: Autoimmune activity, immune status, inflammatory biomarkers, complement system

Occurrence and changes in molecular biomarkers

Biomarker-related: Structural changes in the brain and in brain functions

Structural and functional alterations in MRI imaging in cortical and subcortical regions and fibre tracts with relevance to neurocognitive processes