Visit | 1 | 2 | 3 | 4 |
Timing | Enrolment | 3 months±14 days | 6 months±14 days | 9 months±14 days |
Informed consent | X | |||
Randomisation | X | |||
Baseline CRF | X | |||
F/U form | X | X | X | |
Concomitant medications | X | X | X | X |
Bilateral Villalta score and PTS assessment | X | X | X | X |
QOL | X | X | X | X |
Patient’s overall satisfaction with treatment | X | X | ||
Compliance to study treatment | X | X | ||
Assessment of unblinding | X | |||
SAE: VTE recurrence, death, drug-related SAE | To be completed anytime SAE is suspected | |||
Withdrawal | To be completed whenever a patient withdraws from the study |
CRF, case report form; F/U, follow-up; PTS, post-thrombotic syndrome; QOL, quality of life; SAE, serious adverse event; VTE, venous thromboembolism.