Table 4.
Comparison of Investigators’ and Patients’ Tolerability Evaluation Among the Treatment Groups
| Evaluation | Treatment (Group) | p-value between groupsa | ||||||
|---|---|---|---|---|---|---|---|---|
| A | B | C | ||||||
| n | % | n | % | n | % | |||
| Investigators’ Tolerability score | ||||||||
| D28 | 1–2 | 58 | 60.40% | 91 | 95.80% | 91 | 96.90% | <0.001* |
| 3–4 | 38 | 39.50% | 4 | 4.30% | 3 | 3.20% | ||
| D56 | 1–2 | 62 | 64.50% | 84 | 89.40% | 81 | 86.20% | 0.005* |
| 3–4 | 34 | 35.40% | 10 | 10.70% | 13 | 13.90% | ||
| p-value D28-D56 within groupb | 0.904 | 0.135 | 0.212 | |||||
| Patients’ Tolerability score | ||||||||
| D28 | 0 | 96 | 100.00% | 0 | 0.00% | 0 | 0.00% | 0.814c |
| 1–2 | 0 | 0.00% | 90 | 94.70% | 87 | 92.60% | ||
| 3–4 | 0 | 0.00% | 5 | 5.30% | 7 | 7.50% | ||
| D56 | 0 | 96 | 100.00% | 0 | 0.00% | 0 | 0.00% | 0.314c |
| 1–2 | 0 | 0.00% | 84 | 89.30% | 81 | 86.20% | ||
| 3–4 | 0 | 0.00% | 10 | 10.70% | 13 | 13.90% | ||
| p-value D28-D56 within groupb | 1 | 0.040* | 0.785 | |||||
Notes: *statistically significant with p<0.005; aChi square test, 1–2 and 3–4 levels were combined; bMcNemar test; ccomparison between B and C Groups only, 1–2 and 3–4 levels were combined.