Table 2.
Adverse events occurring in 20% or more patients in either group
| Adverse events | NK105 (N = 214) | PTX (N = 213) | ||||
|---|---|---|---|---|---|---|
| Grade | Grade | |||||
| Preferred term | Any | 3 | 4 | Any | 3 | 4 |
| Haematological, n (%) | ||||||
| Neutropeniaa | 109 (50.9) | 54 (25.2) | 18 (8.4) | 103 (48.4) | 55 (25.8) | 10 (4.7) |
| Leukopeniab | 72 (33.6) | 32 (15.0) | 2 (0.9) | 68 (31.9) | 30 (14.1) | 0 (0.0) |
| Non-haematological, n (%) | ||||||
| Alopecia | 151 (70.6) | 0 (0.0) | 0 (0.0) | 161 (75.6) | 0 (0.0) | 0 (0.0) |
| Peripheral sensory neuropathy | 113 (52.8) | 3 (1.4) | 0 (0.0) | 149 (70.0) | 16 (7.5) | 0 (0.0) |
| Rash | 62 (29.0) | 0 (0.0) | 0 (0.0) | 47 (22.1) | 0 (0.0) | 0 (0.0) |
| Nausea | 59 (27.6) | 5 (2.3) | 0 (0.0) | 65 (30.5) | 0 (0.0) | 0 (0.0) |
| Nasopharyngitis | 49 (22.9) | 0 (0.0) | 0 (0.0) | 46 (21.6) | 0 (0.0) | 0 (0.0) |
| Diarrhoea | 47 (22.0) | 4 (1.9) | 0 (0.0) | 41 (19.2) | 1 (0.5) | 0 (0.0) |
| Fatigue | 45 (21.0) | 1 (0.5) | 0 (0.0) | 36 (16.9) | 0 (0.0) | 0 (0.0) |
| Stomatitis | 42 (19.6) | 2 (0.9) | 0 (0.0) | 46 (21.6) | 0 (0.0) | 0 (0.0) |
| Nail discolouration | 37 (17.3) | 0 (0.0) | 0 (0.0) | 46 (21.6) | 0 (0.0) | 0 (0.0) |
| Myalgia | 32 (15.0) | 0 (0.0) | 0 (0.0) | 46 (21.6) | 0 (0.0) | 0 (0.0) |
| Dysgeusia | 30 (14.0) | 0 (0.0) | 0 (0.0) | 53 (24.9) | 0 (0.0) | 0 (0.0) |
aNeutropenia included neutrophil count decreased
bLeukopenia included white blood cell count decreased