Table 2. Primary and secondary mucositis end points in evaluable patients by allocationa.
| Placebo, N=91 | Caphosol, N=91 | P-valueb | |
|---|---|---|---|
|
WHO mucositis scale (primary end point) | |||
| Mean days of severe (WHO Grade 3 or 4) mucositis (s.d.) | 4.5 (4.8) | 4.5 (5.0) | 0.99 |
| Incidence of severe oral mucositis | 62 (68%) | 57 (63%) | 0.44 |
| Maximum WHO Grade | 0.46 | ||
| Grade 0 | 2 (2.2%) | 7 (7.7%) | |
| Grade 1 | 8 (8.8%) | 7 (7.7%) | |
| Grade 2 | 19 (20.9%) | 20 (22.0%) | |
| Grade 3 | 42 (46.2%) | 35 (38.5%) | |
| Grade 4 | 20 (22.0%) | 22 (24.2%) | |
| Evaluable patients with average of ⩾2 daily doses | 76 (83.5%) | 77 (84.6%) | |
| Mean days of severe mucositis (s.d.) | 4.2 (4.7) | 4.3 (5.0) | 0.88 |
| Pain Categorical Rating Scale (range 0–10)c | 0.78 | ||
| Mean AUC (s.d.) | 45.5 (36.0) | 44.0 (35.6) | |
|
Oral Mucositis Daily Questionnairec | |||
| Mouth and throat pain: mean AUC (s.d.) | 22.3 (14.8) | 21.4 (15.7) | 0.70 |
| Sleeping: mean AUC (s.d.) | 9.3 (10.9) | 7.3 (9.0) | 0.17 |
| Swallowing: mean AUC (s.d.) | 21.4 (15.7) | 19.9 (15.9) | 0.53 |
| Drinking: mean AUC (s.d.) | 21.7 (16.3) | 20.6 (17.3) | 0.66 |
| Eating: mean AUC (s.d.) | 27.9 (19.4) | 26.6 (20.7) | 0.65 |
| Talking: mean AUC (s.d.) | 12.2 (11.5) | 12.0 (13.2) | 0.94 |
Abbreviations: AUC=area under the curve; WHO=World Health Organisation.
a
Evaluable patients defined as patients with ⩾11 daily WHO assessments.
b
Categorical variables compared using χ2 test and continuous variables compared using a two-sampled t-test.
c
Missing daily scores at the end of study period were imputed by last value carried forward before calculating AUC.