(a)
| Group | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
System Organ Class |
Placebo | 120 mg | 160 mg |
RR (95% CI) |
||||||||
| N = 36 | N = 36 | N = 34 | ||||||||||
| # (%) of | # of | Rate | # (%) of | # of | Rate | # (%) of | # of | Rate | Placebo vs. 120 mg | Placebo vs 160 mg | 120 mg vs. 160 mg | |
| Subjects | Events | Subjects | Events | Subjects | Events | |||||||
| Blood | 0 (0.0%) | 0 | 0.000 | 1 (2.8%) | 1 | 0.009 | 0 (0.0%) | 0 | 0.000 | N/A | N/A | N/A |
| Cardiac | 2 (5.6%) | 2 | 0.018 | 1 (2.8%) | 1 | 0.009 | 1 (2.9%) | 1 | 0.009 | 0.50 (0.05, 5.27) | 1.89 (0.18, 19.89) | 0.94 (0.06, 14.51) |
| Gastrointestinal | 4 (11.1%) | 4 | 0.035 | 7 (19.4%) | 13 | 0.117 | 9 (26.5%) | 14 | 0.122 | 1.75 (0.56, 5.46) | 0.42 (0.14, 1.24) | 0.73 (0.31, 1.75) |
| General | 2 (5.6%) | 2 | 0.018 | 3 (8.3%) | 3 | 0.027 | 5 (14.7%) | 7 | 0.061 | 1.50 (0.27, 8.45) | 0.38 (0.08, 1.82) | 0.57 (0.15, 2.19) |
| Infections | 9 (25.0%) | 11 | 0.097 | 6 (16.7%) | 7 | 0.063 | 4 (11.8%) | 4 | 0.035 | 0.67 (0.26, 1.68) | 2.13 (0.72, 6.26) | 1.42 (0.44, 4.59) |
| Injury, Poisoning and Procedural Comp. | 5 (13.9%) | 5 | 0.044 | 4 (11.1%) | 6 | 0.054 | 4 (11.8%) | 7 | 0.061 | 0.80 (0.23, 2.74) | 1.18 (0.35, 4.03) | 0.94 (0.26, 3.48) |
| Investigations | 6 (16.7%) | 8 | 0.071 | 8 (22.2%) | 8 | 0.072 | 8 (23.5%) | 9 | 0.078 | 1.33 (0.51, 3.46) | 0.71 (0.27, 1.83) | 0.94 (0.40, 2.23) |
| Metabolic | 1 (2.8%) | 1 | 0.009 | 1 (2.8%) | 1 | 0.009 | 0 (0.0%) | 0 | 0.000 | 1.00 (0.07, 15.38) | N/A | N/A |
| Musculoskeletal | 1 (2.8%) | 1 | 0.009 | 5 (13.9%) | 5 | 0.045 | 5 (14.7%) | 6 | 0.052 | 5.00 (0.61, 40.70) | 0.19 (0.02, 1.54) | 0.94 (0.30, 2.98) |
| Neoplasms | 0 (0.0%) | 0 | 0.000 | 1 (2.8%) | 1 | 0.009 | 1 (2.9%) | 1 | 0.009 | N/A | N/A | 0.94 (0.06, 14.51) |
| Nervous System | 8 (22.2%) | 9 | 0.080 | 6 (16.7%) | 7 | 0.063 | 4 (11.8%) | 6 | 0.052 | 0.75 (0.29, 1.94) | 1.89 (0.63, 5.70) | 1.42 (0.44, 4.59) |
| Psychiatric | 4 (11.1%) | 6 | 0.053 | 8 (22.2%) | 11 | 0.099 | 8 (23.5%) | 9 | 0.078 | 2.00 (0.66, 6.06) | 0.47 (0.16, 1.43) | 0.94 (0.40, 2.23) |
| Renal | 1 (2.8%) | 1 | 0.009 | 2 (5.6%) | 2 | 0.018 | 2 (5.9%) | 2 | 0.017 | 2.00 (0.19, 21.09) | 0.47 (0.04, 4.97) | 0.94 (0.14, 6.33) |
| Reproductive | 0 (0.0%) | 0 | 0.000 | 1 (2.8%) | 1 | 0.009 | 0 (0.0%) | 0 | 0.000 | N/A | N/A | N/A |
| Respiratory | 1 (2.8%) | 1 | 0.009 | 3 (8.3%) | 5 | 0.045 | 4 (11.8%) | 4 | 0.035 | 3.00 (0.33, 27.50) | 0.24 (0.03, 2.01) | 0.71 (0.17, 2.94) |
| Skin | 1 (2.8%) | 1 | 0.009 | 2 (5.6%) | 2 | 0.018 | 1 (2.9%) | 1 | 0.009 | 2.00 (0.19, 21.09) | 0.94 (0.06, 14.51) | 1.89 (0.18, 19.89) |
| Vascular | 0 (0.0%) | 0 | 0.000 | 1 (2.8%) | 1 | 0.009 | 2 (5.9%) | 2 | 0.017 | N/A | N/A | 0.47 (0.04, 4.97) |
| Total | 26 (72.2%) | 52 | 0.460 | 29 (80.6%) | 75 | 0.676 | 30 (88.2%) | 73 | 0.635 | 1.12 (0.86, 1.44) | 0.82 (0.65, 1.04) | 0.91 (0.75, 1.12) |