Table 1

Time schedule of enrolment, interventions, assessments and visits

ProceduresV0V1V2
(two months)
V3
(four months)
V4
(six months)
V5
(12 months)
V6
12–24 months
ScreenBaseline/randomisation to pathway 1 or 2Follow-upFollow-upFollow-upFollow-upData collection from sites
Eligibility assessmentx
Randomisationx
Informed consentx
Demographicsx
Medical historyxxxxx
Physical examinationx
Vital signs (incl height and weight)xxxxx
Pregnancy testx
Concomitant medicationsxxxxx
Standard practice bloods (includes blood sugar if applicable)xxxxxx
Hepatitis B, C and HIV serologyx
Immunoglobulins (blood)xxx
Extra blood samples (optional)xx
Dispensing of trial drugsx*
Compliancex
QofL FACT-Th6, V.4xxxxxx
QofL ICECAP V.2—A measurexxxxxx
QofL SF-36V.2— Health Surveyxxxxxx
QofL FACIT-F, V.4, pg 3 (fatigue)xxxxxx
QofL Thrombocytopenia costs questionnairexxxxxx
Data collection from sites on platelet count and treatmentxxxxxx
  • *MMF and corticosteroid dispensing frequency can follow standard local practice.

  • MMF, mycophenolate mofetil; QofL, quality of life.