Table III.
Number (percent) of patients with ≥1 adverse events by body system in which event occurred.
| Primary analysis (n=60) | Serious adverse events
|
Non-serious adverse events
|
||||
|---|---|---|---|---|---|---|
| Body system | Celecoxib/Creatine | Minocycline/Creatine | p-value for χ2 | Celecoxib/Creatine | Minocycline/Creatine | p-value for χ2 |
| Cardiovascular | 1 (3.3) | 1 (3.3) | 1.000a | 3 (10.0) | 2 (6.7) | 1.000a |
| Dermatological | 0 (0.0) | 0 (0.0) | 15 (50.0) | 10 (33.3) | 0.190 | |
| Ears, Nose and Throat | NA | NA | 13 (43.3) | 10 (33.3) | 0.426 | |
| Endocrine/metabolic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (6.7) | 0.492a | |
| Eyes | 0 (0.0) | 0 (0.0) | 9 (30.0) | 5 (16.7) | 0.222 | |
| Gastrointestinal | 1 (3.3) | 2 (6.7) | 1.000a | 19 (63.3) | 21 (70.0) | 0.584 |
| Genitourinary | 0 (0.0) | 0 (0.0) | 10 (33.3) | 7 (23.3) | 0.390 | |
| Hematological | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 1.000a | |
| Musculoskeletal | 2 (6.7) | 1 (3.3) | 1.000a | 14 (46.7) | 12 (40.0) | 0.602 |
| Neurological | 0 (0.0) | 0 (0.0) | 4 (13.3) | 6 (20.0) | 0.488 | |
| Other | 0 (0.0) | 0 (0.0) | 7 (23.3) | 7 (23.3) | 1.000 | |
| Psychological | 0 (0.0) | 0 (0.0) | 4 (13.3) | 9 (30.0) | 0.117 | |
| Respiratory | 1 (3.3) | 2 (6.7) | 1.000a | 6 (20.0) | 3 (10.0) | 0.472a |
| Total | 5 (16.7) | 5 (16.7) | 1.000 | 29 (96.7) | 30 (100.0) | 1.000a |
| Mean number of AEs per person (SD) | 0.23 (0.57) | 0.37 (0.89) | 0.873b | 5.33 (3.89) | 5.00 (2.92) | 0.994b |
| Cardiovascular | 2 (4.3) | 2 (5.1) | 1.000a | 7 (14.9) | 2 (5.1) | 0.174a |
| Dermatological | 0 (0.0) | 0 (0.0) | 23 (48.9) | 12 (30.8) | 0.088 | |
| Ears, Nose and Throat | NA | NA | 19 (40.4) | 12 (30.8) | 0.353 | |
| Endocrine/metabolic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.1) | 0.203a | |
| Eyes | 0 (0.0) | 0 (0.0) | 11 (23.4) | 5 (12.8) | 0.209 | |
| Gastrointestinal | 2 (4.3) | 2 (5.1) | 1.000a | 27 (57.4) | 28 (71.8) | 0.168 |
| Genitourinary | 0 (0.0) | 0 (0.0) | 13 (27.7) | 10 (25.6) | 0.833 | |
| Hematological | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1.000a | |
| Musculoskeletal | 3 (6.4) | 1 (2.6) | 0.623a | 21 (44.7) | 16 (41.0) | 0.733 |
| Neurological | 0 (0.0) | 0 (0.0) | 6 (12.8) | 7 (17.9) | 0.504 | |
| Other | 0 (0.0) | 1 (2.6) | 0.453a | 10 (21.3) | 8 (20.5) | 0.931 |
| Psychological | 0 (0.0) | 0 (0.0) | 6 (12.8) | 11 (28.2) | 0.073 | |
| Respiratory | 2 (4.3) | 4 (10.3) | 0.254a | 11 (23.4) | 4 (10.3) | 0.110 |
| Total | 9 (19.1) | 8 (20.5) | 0.874 | 45 (95.7) | 39 (100.00) | 0.498a |
| Mean number of AEs per person (SD) | 0.30 (0.69) | 0.41 (0.88) | 0.760b | 4.98 (3.44) | 4.67 (2.88) | 0.814b |
a
Fisher’s exact test due to expected cell counts <5.
b
Wilcoxon rank-sum test.