Table 3.
Grade 3, 4, and 5 treatment-emergent adverse events occurring in >5% of patients treated with vosaroxin or placebo in combination with cytarabine
| n (%) | Grade 3 | Grade 4 | Grade 5 | |||
|---|---|---|---|---|---|---|
| vos/cyt (n=355) | pla/cyt (n=350) | vos/cyt (n=355) | pla/cyt (n=350) | vos/cyt (n=355) | pla/cyt (n=350) | |
| Any AE | 133 (37·5) | 140 (40) | 151 (42·5) | 129 (36·9) | 50 (14·1) | 26 (7·4) |
| Haematologic events | ||||||
| Febrile neutropenia | 163 (45·9) | 115 (32·9) | 4 (1·1) | 2 (0·6) | 0 | 0 |
| Thrombocytopenia | 6 (1·7) | 8 (2·3) | 78 (22) | 79 (22·6) | 0 | 0 |
| Anaemia | 72 (20·3) | 76 (21·7) | 6 (1·7) | 5 (1·4) | 0 | 0 |
| Neutropenia | 9 (2·5) | 5 (1·4) | 57 (16·1) | 44 (12·6) | 0 | 0 |
| Nonhaematologic events | ||||||
| Stomatitis | 48 (13·5) | 10 (2·9) | 6 (1·7) | 0 | 0 | 0 |
| Diarrhoea | 19 (5·4) | 7 (2·0) | 1 (0·3) | 0 | 0 | 0 |
| Pneumonia | 23 (6·5) | 16 (4·6) | 3 (0·8) | 1 (0·3) | 13 (3·7) | 9 (2·6) |
| Sepsis | 8 (2·3) | 5 (1·4) | 20 (5·6) | 7 (2·0) | 14 (3·9) | 6 (1·7) |
| Bacteraemia | 39 (11·0) | 14 (4·0) | 4 (1·1) | 1 (0·3) | 0 | 1 (0·3) |
| Hypokalaemia | 41 (11·5) | 19 (5·4) | 11 (3·1) | 2 (0·6) | 0 | 0 |
| Hypophosphataemia | 25 (7·0) | 11 (3·1) | 3 (0·8) | 0 | 0 | 0 |
| Hyperglycaemia | 18 (5·1) | 15 (4·3) | 1(0·3) | 0 | 0 | 0 |
| Decreased appetite | 20 (5·6) | 7 (2·0) | 0 | 0 | 0 | 0 |
| Hypertension | 21 (5·9) | 12 (3·4) | 0 | 0 | 0 | 0 |
AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; cyt=cytarabine; pla=placebo; vos=vosaroxin.