Table 5.
Summary of the change of quality of life
| ITT population | Overall (%) | Topaal (%) | Nacid (%) | P-value |
| Visit 1/baseline | ||||
| Observed data | 0.9298 | |||
| No symptom | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Moderate symptom | 4 (3.3) | 3 (4.6) | 1 (1.8) | |
| Moderate symptom w/o interfering | 29 (24.0) | 13 (20.0) | 16 (28.6) | |
| Moderate symptom with interfering | 61 (50.4) | 35 (53.9) | 26 (46.4) | |
| Symptom as bad/worse | 27 (22.3) | 14 (21.5) | 13 (23.2) | |
| Study end | ||||
| Observed data | <0.0001 | |||
| No symptom | 24 (19.8) | 19 (29.2) | 5 (8.9) | |
| Moderate symptom | 51 (42.2) | 34 (52.3) | 17 (30.4) | |
| Moderate symptom w/o interfering | 27 (22.3) | 8 (12.3) | 19 (33.9) | |
| Moderate symptom with interfering | 15 (12.4) | 3 (4.6) | 12 (21.4) | |
| Symptom as bad/worse | 4 (3.3) | 1 (1.5) | 3 (5.4) | |
| Decrease from baseline | <0.0001 | |||
| –1 | 1 (0.8) | 0 (0.0) | 1 (1.8) | |
| 0 | 24 (19.8) | 7 (10.8) | 17 (30.4) | |
| 1 | 36 (29.8) | 16 (24.6) | 20 (35.7) | |
| 2 | 36 (29.8) | 22 (33.9) | 14 (25.0) | |
| 3 | 16 (13.2) | 13 (20.0) | 3 (5.4) | |
| 4 | 8 (6.6) | 7 (10.8) | 1 (1.8) |
1Mantel–Henszel χ2 test.