Table 4.
Deaths, discontinuations, and grade 3 or 4 haematological toxicity by treatment group and investigator preselection
| Total ITT (n=358) |
BSC only (N=222) |
Low-dose cytarabine (N=94) |
Intensive chemotherapy (N=42) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azacitidine (n=179) |
Conventional care (n=179) |
Azacitidine (n=117) |
BSC (n=105) |
Azacitidine (n=45) |
Low-dose cytarabine (n=49) |
Azacitidine (n=17) |
Intensive chemotherapy (n=25) |
|||||
| Deaths | 82 (46%) | 113 (63%) | 53 (45%) | 66 (63%) | 20 (44%) | 31 (63%) | 9 (53%) | 16 (64%) | ||||
| Deaths during first 3 months* of treatment | 20 (11%) | 16 (9%) | 13 (11%) | 9 (9%) | 5 (11%) | 7 (14%) | 2 (12%) | 0 | ||||
| Safety population | 175 | 165 | 114 | 102 | 45 | 44 | 16 | 19 | ||||
| Discontinuation before study completion due to haematological adverse events† |
8 (5%) | 4 (2%) | 3 (3%) | 2 (2%) | 4 (9%) | 2 (5%) | 1 (6%) | 0 | ||||
| Grade 3 or 4 toxicity‡ | ||||||||||||
| Neutropenia | 159 (91%) | 126 (76%) | 104 (91%) | 70 (69%) | 40 (89%) | 39 (89%) | 15 (94%) | 17 (90%) | ||||
| Thrombocytopenia | 149 (85%) | 132 (80%) | 93 (82%) | 72 (71%) | 42 (93%) | 42 (96%) | 14 (88%) | 18 (95%) | ||||
| Anaemia | 100 (57%) | 112 (68%) | 62 (54%) | 67 (66%) | 29 (64%) | 34 (77%) | 9 (56%) | 11 (58%) | ||||
| Baseline grade 0–2 progressed to grade 3 or 4 during treatment† | ||||||||||||
| Neutropenia | 67/80 (84%) | 46/76 (61%) | 45/53 (85%) | 22/46 (48%) | 14/18 (78%) | 19/24 (79%) | 8/9 (89%) | 5/6 (83%) | ||||
| Thrombocytopenia | 72/97 (74%) | 68/94 (72%) | 49/69 (71%) | 29/54 (54%) | 17/20 (85%) | 29/30 (97%) | 6/8 (75%) | 10/10 (100%) | ||||
| Anaemia | 84/156 (54%) | 83/130 (64%) | 52/103 (51%) | 48/79 (61%) | 25/40 (63%) | 28/37 (76%) | 7/13 (54%) | 7/14 (50%) | ||||
Data are number (%) or number/number with data (%).
*
3 months = 91 days.
†
Study completion defined as 12 months after the last patient was randomised.
‡
National Cancer Institute’s Common Toxicity Criteria toxicities based on laboratory data.