TABLE 2.
TEAEs through the EOC6 in ≥10% of patients treated with fedratinib with platelet counts of 50 to <100 × 109/l at study entry
| Category Preferred term | 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) | |
| Non‐haematological, % | |||
| Diarrhoea | 6 | 50 | 66 |
| Nausea | 17 | 54 | 60 |
| Vomiting | 11 | 38 | 40 |
| Constipation | 11 | 17 | 15 |
| Pruritus | 0 | 15 | 8 |
| Abdominal pain | 17 | 15 | 12 |
| Dyspnoea | 11 | 13 | 7 |
| Epistaxis | 11 | 13 | 4 |
| Fatigue | 17 | 10 | 15 |
| Urinary tract infection | 0 | 10 | 9 |
| Peripheral oedema | 11 | 10 | 8 |
| Haematological, % | |||
| Anaemia | 17 | 52 | 39 |
| Thrombocytopaenia | 28 | 44 | 9 |
Includes patients from the pooled JAKARTA, JAKARTA2, and ARD11936 trials. For comparison, TEAE rates are also shown for patients in the Low‐Platelets cohort who were randomised to placebo, and for patients treated with fedratinib with baseline platelet counts ≥100 × 109/l.
A TEAE was defined as any event that started or worsened in severity between the time of first dose and 30 days after either the last dose of study drug or the EOC6, whichever came first.
Abbreviations: EOC6, end of cycle 6; TEAE, treatment‐emergent adverse event.
a
Includes only TEAEs that occurred prior to fedratinib crossover.