Table 4:
Most common adverse events up to week 24 or initial treatment discontinuation
| Pacritinib (n=220) |
BAT (n=106) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | All | Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | All | |
| Diarrhoea | 109 (50%) | 11 (5%) | 0 | 0 | 120 (55%) | 11 (10%) | 0 | 0 | 0 | 11 (10%) |
| Nausea | 58 (26%) | 2 (1%) | 0 | 0 | 60 (27%) | 7 (7%) | 0 | 0 | 0 | 7 (7%) |
| Anaemia | 15 (7%) | 32 (15%) | 5 (2%) | 0 | 52 (24%) | 5 (5%) | 13 (12%) | 3 (3%) | 0 | 21 (20%) |
| Thrombocytopenia | 11 (5%) | 12 (5%) | 14 (6%) | 0 | 37 (17%) | 3 (3%) | 9 (8%) | 3 (3%) | 0 | 15 (14%) |
| Vomiting | 34 (15%) | 2 (1%) | 0 | 0 | 36 (16%) | 6 (6%) | 0 | 0 | 0 | 6 (6%) |
| Fatigue | 17 (8%) | 5 (2%) | 0 | 0 | 22 (10%) | 9 (8%) | 1 (1%) | 0 | 0 | 10 (9%) |
| Abdominal pain | 18 (8%) | 3 (1%) | 0 | 0 | 21 (10%) | 10 (9%) | 0 | 0 | 0 | 10 (9%) |
| Peripheral oedema | 16 (7%) | 1 (<1%) | 0 | 0 | 17 (8%) | 12 (11%) | 1 (1%) | 0 | 0 | 13 (12%) |
| Decreased appetite | 11 (5%) | 1 (<1%) | 0 | 0 | 12 (5%) | 3 (3%) | 0 | 0 | 0 | 3 (3%) |
| Electrocardiogram QT prolonged | 9 (4%) | 3 (1%) | 0 | 0 | 12 (5%) | 1 (1%) | 0 | 0 | 0 | 1 (1%) |
| Pyrexia | 7 (3%) | 4 (2%) | 0 | 0 | 11 (5%) | 10 (9%) | 1 (1%) | 0 | 0 | 11 (10%) |
| Pneumonia | 3 (1%) | 4 (2%) | 0 | 1 (<1%) | 8 (4%) | 0 | 0 | 0 | 0 | 0 |
| Leucopenia | 3 (1%) | 3 (1%) | 1 (<1%) | 0 | 7 (3%) | 0 | 2 (2%) | 0 | 0 | 2 (2%) |
| Hypertension | 2 (1%) | 5 (2%) | 0 | 0 | 7 (3%) | 1 (1%) | 0 | 0 | 0 | 1 (1%) |
| Cardiac failure | 1 (<1%) | 5 (2%) | 0 | 0 | 6 (4%) | 0 | 1 (1%) | 0 | 1 (1%) | 2 (2%) |
| Atrial fibrillation | 1 (<1%) | 3 (1%) | 0 | 0 | 4 (2%) | 1 (1%) | 0 | 0 | 0 | 1 (1%) |
Data are n (%). Table shows all-grade adverse events in more than 5% of patients in the pacritinib group or grade 3 in more than 1% of patients in the pacritinib group. Additional grade 4 adverse events in the pacritinib group were neutropenia (n=4), platelet count reduction (n=3), hyperuricemia (n=2), hyperkalaemia (n=1), cardiac failure congestive (n=1), thrombocytosis (n=1), sepsis (n=1), delayed haemolytic transfusion reaction (n=1), neutrophil count reduction (n=1), cerebral haemorrhage (n=1), and acute respiratory distress syndrome (n=1). Additional grade 5 adverse events in the pacritinib group were disease progression (n=1), cardiorespiratory arrest (n=1), and multiorgan failure (n=1). Additional grade 4 adverse events in the BAT group were neutropenia (n=1), colon neoplasm (n=1), hypoglycaemia (n=1), sepsis (n=1), hyponatraemia (n=1), septic shock (n=1), acute respiratory distress syndrome (n=1). Additional grade 5 adverse events in the BAT group were disease progression (n=1) and sepsis (n=1). BAT=best available therapy.