Procedures | V0 | V1 | V2 (two months) | V3 (four months) | V4 (six months) | V5 (12 months) | V6 12–24 months |
Screen | Baseline/randomisation to pathway 1 or 2 | Follow-up | Follow-up | Follow-up | Follow-up | Data collection from sites | |
Eligibility assessment | x | ||||||
Randomisation | x | ||||||
Informed consent | x | ||||||
Demographics | x | ||||||
Medical history | x | x | x | x | x | ||
Physical examination | x | ||||||
Vital signs (incl height and weight) | x | x | x | x | x | ||
Pregnancy test | x | ||||||
Concomitant medications | x | x | x | x | x | ||
Standard practice bloods (includes blood sugar if applicable) | x | x | x | x | x | x | |
Hepatitis B, C and HIV serology | x | ||||||
Immunoglobulins (blood) | x | x | x | ||||
Extra blood samples (optional) | x | x | |||||
Dispensing of trial drugs | x* | ||||||
Compliance | x | ||||||
QofL FACT-Th6, V.4 | x | x | x | x | x | x | |
QofL ICECAP V.2—A measure | x | x | x | x | x | x | |
QofL SF-36V.2— Health Survey | x | x | x | x | x | x | |
QofL FACIT-F, V.4, pg 3 (fatigue) | x | x | x | x | x | x | |
QofL Thrombocytopenia costs questionnaire | x | x | x | x | x | x | |
Data collection from sites on platelet count and treatment | x | x | x | x | x | x |
*MMF and corticosteroid dispensing frequency can follow standard local practice.
MMF, mycophenolate mofetil; QofL, quality of life.