Table 2. Adverse events.
|
Arm A (N=45) |
Arm B (N=44) |
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| |
All grades |
Grade 3 or more |
All grades |
Grade 3 or more |
P-value |
|||||
| Adverse event | N | % | N | % | N | % | N | % | All grades | Grade 3 or more |
| Leucopenia |
33 |
73.3 |
10 |
22.2 |
39 |
88.7 |
10 |
22.7 |
0.07 |
0.95 |
| Neutropenia |
27 |
60.0 |
14 |
31.1 |
39 |
88.7 |
18 |
40.9 |
0.002 |
0.34 |
| Anaemia |
23 |
51.1 |
4 |
8.9 |
25 |
56.8 |
7 |
15.9 |
0.59 |
0.31 |
| Thrombocytopenia |
4 |
8.9 |
0 |
0 |
1 |
2.3 |
0 |
0 |
0.18 |
— |
| Elevated transaminases |
12 |
26.7 |
2 |
4.4 |
9 |
20.5 |
0 |
0 |
0.49 |
0.16 |
| Nausea |
7 |
15.6 |
0 |
0.0 |
10 |
22.7 |
0 |
0.0 |
0.39 |
— |
| Vomiting |
2 |
4.4 |
0 |
0.0 |
3 |
6.8 |
0 |
0.0 |
0.63 |
— |
| Anorexia |
15 |
33.3 |
3 |
6.7 |
15 |
34.1 |
2 |
4.5 |
0.94 |
0.66 |
| Diarrhoea |
9 |
20.0 |
0 |
0.0 |
10 |
22.7 |
0 |
0.0 |
0.75 |
— |
| Fatigue |
23 |
51.1 |
2 |
4.4 |
23 |
52.3 |
0 |
0.0 |
0.91 |
0.16 |
| Stomatitis |
5 |
11.1 |
0 |
0.0 |
8 |
18.2 |
0 |
0.0 |
0.35 |
— |
| Allergy |
0 |
0.0 |
0 |
0.0 |
3 |
6.8 |
0 |
0.0 |
0.07 |
— |
| Skin toxicity |
3 |
6.7 |
0 |
0.0 |
9 |
20.5 |
0 |
0.0 |
0.06 |
— |
| Peripheral sensory neuropathy |
28 |
62.2 |
3 |
6.7 |
38 |
86.4 |
6 |
13.6 |
0.009 |
0.27 |
| Peripheral motor neuropathy |
3 |
6.7 |
0 |
0.0 |
8 |
18.2 |
1 |
2.3 |
0.099 |
0.31 |
| Febrile neutropenia |
2 |
4.4 |
2 |
4.4 |
1 |
2.3 |
1 |
2.3 |
0.57 |
0.57 |
| Non-neutropenic infection |
4 |
8.9 |
2 |
4.4 |
2 |
4.5 |
0 |
0.0 |
0.41 |
0.16 |
| Pneumonitis |
1 |
2.3 |
0 |
0.0 |
1 |
2.3 |
0 |
0.0 |
0.99 |
— |
| Myalgia |
8 |
17.8 |
0 |
0.0 |
8 |
18.2 |
0 |
0.0 |
0.96 |
— |
| Arthralgia | 7 | 15.6 | 1 | 2.2 | 9 | 20.5 | 0 | 0.0 | 0.55 | 0.32 |