Table 2.
Primary and secondary efficacy results in the full analysis set (N=40)
| Variable | Baseline (n=40) | Week 6 (n=39) | Week 12 (n=30) | Week 18 (n=19) | Week 26 (n=24) |
|---|---|---|---|---|---|
| SPOM VAS score - Mean (SD) - LSMean (SE) |
70.9 (13.7) |
50.7 (24.6) 48.5 (3.4) |
44.1 (26.0) 47.4 (3.2) |
46.4 (27.9) 49.0 (3.4) |
50.0 (26.8) 50.1 (3.4) |
| SPAN VAS score - Mean (SD) - LSMean (SE) |
70.1 (20.5) |
50.7 (26.4) 49.3 (4.1) |
46.2 (27.8) 49.6 (3.9) |
43.8 (23.9) 50.0 (3.7) |
49.5 (31.8) 51.1 (3.9) |
| Patient global assessment VAS score - Mean (SD) - LSMean (SE) |
40.7 (22.3) |
55.1 (25.2) 58.9 (3.9) |
60.2 (21.3) 59.4 (3.2) |
68.6 (19.5) 61.2 (3.1) |
53.3 (25.6) 57.8 (3.3) |
| ASES patient self-evaluation SSI score - Mean (SD) - LSMean (SE) |
55.2 (19.2) |
62.9 (20.9) 65.2 (3.7) |
65.6 (14.9) 65.8 (3.2) |
58.8 (14.0) 63.5 (3.1) |
60.2 (19.9) 62.0 (3.0) |
| Use of rescue medication since the previous clinic visit - number of patients, n/N (%) - weekly dose [mg], mean (SD)* |
5/32 (15.6) 6000 (NE) |
19/39 (48.7) 3150 (4175) |
12/32 (37.5) 1888 (1843) |
12/25 (48.0) 1916 (1754) |
9/23 (39.1) 3254 (2619) |
Notes: *Not every patient who reported taking rescue medication reported the dose; at baseline, only one patient reported a dose.
Abbreviations: ASES, American shoulder and elbow surgeons; LSMean, least square mean; NE, not evaluable; SD, standard deviation; SE, standard error; SPAN, shoulder pain at night; SPOM, shoulder pain on movement; SSI, shoulder score index; VAS, visual analog scale.