TABLE 4.
Treatment‐emergent thrombocytopaenia/platelet count decreases (any cause) and associated treatment modifications reported through EOC6
| Platelet count 50 to <100 × 109/l | Platelet count ≥100 × 109/l | ||
|---|---|---|---|
| Placebo a (n = 18) | Fedratinib 400 mg (n = 48) | Fedratinib 400 mg (n = 155) | |
| Thrombocytopaenia TEAEs, b n (%) | |||
| All grades | 5 (28) | 21 (44) | 14 (9) |
| Grade 3–4 | 4 (22) | 19 (40) | 7 (5) |
| Serious c | 0 | 0 | 0 |
| Treatment modifications for thrombocytopaenia, n (%) | |||
| Treatment interrupted | 0 | 3 (6) | 1 (0.6) |
| Dose reduced | 0 | 4 (8) | 2 (1) |
| Treatment discontinued | 0 | 3 (6) | 1 (0.6) |
Abbreviations: EOC6, end of cycle 6; TEAE, treatment‐emergent adverse event.
Includes only TEAEs that occurred prior to fedratinib crossover.
Thrombocytopaenia (preferred term) was based on investigator reports of TEAEs, defined as events that started or worsened in severity between the time of first dose up to 30 days after either the last dose of study drug or the EOC6, whichever came first. TEAEs are reported collectively for patients allocated to receive fedratinib 400 mg/day in the JAKARTA, JAKARTA2, or ARD11936 trials, and for patients in JAKARTA who were randomised to placebo.
A serious event was any TEAE that resulted in death, was life‐threatening, required new or prolonged inpatient hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or any other medically important event. Seriousness was determined by the treating investigators.