Table 3. Efficacy end points (as treated analysis).
| End points | Caphosol plus SC (n = 103) |
Standard care (SC) (n = 107) |
p value | ||
|---|---|---|---|---|---|
| No. | % | No. | % | ||
| Primary | |||||
| Incidence of ≥G3 OM | 66 | 64.1 | 70 | 65.4 | 0.839 |
| Secondary | |||||
| Duration of ≥G3 OM (days) | |||||
| Mean (SD) | 16.8 (17.5) | 17.5 (21.9) | 0.692 | ||
| Incidence of ≥G3 PM | 59 | 57.3 | 68 | 64.2 | 0.309 |
| Duration of ≥G3 PM (days) | |||||
| Mean (SD) | 13.7 (16.7) | 18.4 (21.5) | 0.187 | ||
| Incidence of ≥G3 PD | 30 | 29.1 | 33 | 31.1 | 0.752 |
| Duration of ≥G3 PD (days) | |||||
| Mean (SD) | 8.3 (16.7) | 9.7 (19.5) | 0.671 | ||
| Incidence of ≥G3 pain | 50 | 48.5 | 58 | 54.7 | 0.372 |
| Duration of ≥G3 pain | |||||
| Mean (SD) | 18 (24.7) | 20 (24.1) | 0.397 | ||
OM – oral mucositis, PM – pharyngeal mucositis, PD – pharyngeal dysphagia