Table 1.
Demographics and baseline clinical characteristics of patients in modified FAS populationa
| Characteristics | LOX-T | LOX-O | p value |
|---|---|---|---|
| n = 91 | n = 88 | ||
| Age, years (%) | 45.6 (13.9) | 46.4 (14.1) | 0.700 |
| Female, n (%) | 56 (61.5) | 52 (59.1) | 0.738 |
| Height, cm (%) | 164.5 (8.5) | 165.2 (8.0) | 0.423 |
| Weight, kg (%) | 63.4 (11.8) | 64.7 (11.4) | 0.476 |
| BMI, kg/cm2 (%) | 23.3 (3.2) | 23.6 (3.0) | 0.552 |
| Affected sites, n (%) | 0.808 | ||
| Neck | 14 (15.4) | 10 (11.4) | |
| Shoulders | 17 (18.7) | 14 (15.9) | |
| Arms | 4 (4.4) | 2 (2.3) | |
| Back and waist | 38 (41.8) | 45 (51.1) | |
| Legs | 14 (15.4) | 15 (17.0) | |
| Buttocks | 1 (1.1) | 0 (0.0) | |
| Other | 3 (3.3) | 2 (2.3) | |
| Duration of myalgia (d) | 0.905 | ||
| Mean (SD) | 4.6 (11.6) | 8.5 (22.2) | |
| Median (min–max) | 1.0 (1–78) | 1.0 (1–98) | |
| Allergy history, n (%) | 0 | 0 | |
| Comorbidity, n (%) | 11 (12.1) | 13 (14.8) | 0.598 |
| Medical/surgical history, n (%) | 15 (16.5) | 17 (19.3) | 0.621 |
| Clinical symptoms, n (%) | |||
| Pain at rest | 0.049 | ||
| No symptom | 12 (13.2) | 16 (18.2) | |
| Mild | 37 (40.7) | 45 (51.1) | |
| Moderate | 40 (44.0) | 25 (28.4) | |
| Severe | 2 (2.2) | 2 (2.3) | |
| Clinical symptom score at baseline, mean (SD) | |||
| Rest pain | 1.4 (0.7) | 1.1 (0.7) | 0.049 |
| Tenderness | 1.7 (0.7) | 1.5 (0.8) | 0.251 |
| Motion pain | 1.9 (0.5) | 1.8 (0.6) | 0.798 |
| Total score | 6.4 (1.6) | 5.8 (1.7) | 0.010 |
BMI body mass index, FAS full analysis set, SD standard deviation
aModified FAS population excluded subjects who had history of myalgia for > 10 years; two subjects were excluded from LOX-O study group