Table 2 Trial schedule
Trial assessment | Enrolment (consent) | Days between enrolment and randomisation | Day R Day of randomisation platelet count ≤50 × 109/L | Days between day R and study day 1 | Day 1 | Day 2 | Days 3–11 | Day 12 (± 2) | Days 13–29 | Day 30 (± 2) | Day 60 (± 3) | Day 120 (± 14) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Demographics and medical history | X | |||||||||||
Eligibility assessment | X | X | X (Prior to starting drug) | |||||||||
Informed consent | X | |||||||||||
Transfusion requirements | X | X | X | X | X | X | X | X | ||||
Bleeding assessment | X | X | X | X | X | X | X | X | ||||
Trial treatment accountability | X | X | X | X | X | X | ||||||
Quality-of-life assessment | X | X | X | X | ||||||||
Health economic evaluation | X | X | ||||||||||
Thrombotic assessment | Medical notes | Medical notes | Medical notes | Medical notes | Medical notes | Medical notes | Medical notes | Medical notes | Face-to-face or telephone follow-up | Face-to-face or telephone follow-up | ||
Highest recorded temperature each day | X | X | X | X | X | X | ||||||
Serious adverse event assessment | X | X | X | X | X | X | X | X | X |