Table 2 PI before randomization and before treatment administration (ITT population)
DKP 12.5 mg + TRAM 37.5 mg | DKP 12.5 mg + TRAM 75 mg | DKP 25 mg + TRAM 37.5 mg | DKP 25 mg + TRAM 75 mg | DKP 12.5 mg | DKP 25 mg | TRAM 37.5 mg | TRAM 75 mg | Ibuprofen | Placebo | Overall | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | 60 | 62 | 63 | 61 | 60 | 60 | 59 | 59 | 60 | 62 | 606 | |
PI before randomization | ||||||||||||
VAS | Mean (SD) | 58.28 (12.50) | 57.74 (11.54) | 56.25 (10.79) | 57.72 (11.63) | 58.33 (12:49) | 57.72 (12.55) | 57.10 (11:73) | 56.32 (11.42) | 57.33 (13:46) | 60.34 (13.39) | 57.72 (12.13) |
VRS | Moderate n (%) | 48 (80.0) | 53 (85.5) | 48 (76.2) | 48 (78.7) | 45 (75.0) | 47 (78.3) | 56 (94.9) | 47 (79.7) | 51 (85.0) | 46 (74.2) | 489 (80.7) |
Severe n (%) | 12 (20.0) | 9 (14.5) | 15 (23.8) | 13 (21.3) | 15 (25.0) | 13 (21.7) | 3 (5.1) | 12 (20.3) | 9 (15.0) | 16 (25.8) | 117 (19.3) | |
PI before treatment administration (baseline PI) | ||||||||||||
VRS | Mild n (%) | 1 (1.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 1 (1.6) | 3 (0.5) |
Moderate n (%) | 40 (66.7) | 43 (69.4) | 39 (61.9) | 41 (67.2) | 35 (58.3) | 43 (71.7) | 40 (67.8) | 35 (59.3) | 39 (65.0) | 33 (53.2) | 388 (64.0) | |
Severe n (%) | 19 (31.7) | 18 (29.0) | 24 (38.1) | 20 (32.8) | 25 (41.7) | 17 (28.3) | 19 (32.2) | 23 (39.0) | 21 (35.0) | 27 (43.5) | 213 (35.1) | |
Missing n (%) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.6) | 2 (0.3) | |