2.1. Study design
MAY
This was a phase 4, multicenter, observational cohort study (NCT03554759) conducted from July 2018 to January 2019. The study planned to enroll a total of 500 subjects from sites in the USA after avatrombopag was approved for this indication by the FDA in May 2018.Data were collected prospectively or retrospectively from information routinely recorded in a patient’s medical records and from laboratory data. Visits, examinations, laboratory tests, or procedures were not mandated or recommended as part of this study. The duration of patient participation and collection of clinical data was up to 6 weeks from the initial (baseline) visit or data were extracted from an approximately 6-week window of patient visits. Data were entered into the electronic data capture system based on patient visits occurring within approximately 7 calendar days of their first avatrombopag use (baseline visit), during any visits while taking avatrombopag (treatment period), on procedure day, on discharge day (if applicable) and for any visit performed up to 30 days post-procedure (follow-up period).