Table 2.
Treatment success definition | |||||||
Worse (n = 35) |
Unchanged (n = 181) |
Somewhat better (n = 83) |
A good deal better (n = 247) |
A great deal better (n = 314) |
A very great deal better (n = 780) |
All (n = 1640) |
|
GSRS score at 4 weeks | |||||||
0 (no HB) | 5.7 | 13.3 | 21.7 | 32.0 | 57.6 | 87.8 | 60.3 |
≤ 1 (minor HB) | 17.1 | 35.4 | 55.4 | 66.4 | 84.1 | 97.2 | 79.4 |
≤ 2 (mild HB) | 37.1 | 59.7 | 86.7 | 88.3 | 95.2 | 99.0 | 90.4 |
Inv-assessed severity | |||||||
0 (no HB) | 8.6 | 14.4 | 20.5 | 34.8 | 61.1 | 87.4 | 61.3 |
≤ 1 (mild HB) | 34.3 | 61.3 | 85.5 | 86.6 | 95.5 | 98.7 | 90.1 |
Inv-assessed frequency | |||||||
≤ 1 day with HB | 8.6 | 17.1 | 31.3 | 44.9 | 71.0 | 92.2 | 67.9 |
≤ 2 days with HB | 8.6 | 24.9 | 43.4 | 56.7 | 80.3 | 96.2 | 74.8 |
≤ 3 days with HB | 17.1 | 30.4 | 55.4 | 70.9 | 86.9 | 98.2 | 80.5 |
No. of score units improved in GSRS | |||||||
≥ 1 | 31.4 | 60.8 | 83.1 | 85.4 | 91.7 | 99.0 | 89.1 |
≥ 2 | 28.6 | 33.7 | 59.0 | 70.0 | 82.8 | 97.1 | 79.9 |
≥ 3 | 20.0 | 21.0 | 39.8 | 47.0 | 69.7 | 92.4 | 69.1 |
≥ 50% improvement in GSRS | 25.7 | 25.4 | 49.4 | 62.3 | 78.0 | 96.8 | 76.2 |
≥ 1 grade (Inv) improvement | 45.7 | 68.5 | 89.2 | 91.1 | 96.5 | 99.0 | 92.3 |
Improvement in Inv-assessed frequency | |||||||
≥ 1 day | 42.9 | 48.1 | 68.7 | 85.0 | 92.0 | 99.4 | 87.4 |
≥ 2 days | 28.6 | 39.2 | 57.8 | 77.3 | 90.1 | 98.8 | 83.8 |
≥ 3 days | 17.1 | 28.7 | 50.6 | 66.8 | 85.0 | 97.7 | 78.9 |
GSRS = Gastrointestinal Symptom Rating Scale; HB = heartburn; Inv = investigator.