TABLE 3.
Frequencies and estimated relative risk for reported adverse events
| Variable (SOC or PT) | Robenacoxib (n = 222) | Placebo (n = 227) | Relative risk | |
|---|---|---|---|---|
| Estimate | 95% CI | |||
| Behavioral disorders | 8 (3.6%) | 9 (4.0%) | 0.91 | 0.37‐2.27 |
| Behavioral disorder NOS | 3 (1.4%) | 4 (1.8%) | 0.77 | 0.19‐3.1 |
| Inappropriate urination | 3 (1.4%) | 1 (0.4%) | 3.06 | 0.59‐15.80 |
| Blood and lymphatic system disorders | 3 (1.4%) | 3 (1.3%) | 1.24 | 0.31‐4.93 |
| Anemia NOS | 1 (0.5%) | 1 (0.4%) | 1.02 | 0.28‐3.66 |
| Cardiovascular system disorders | 1 (0.5%) | 3 (1.3%) | 0.34 | 0.04‐3.29 |
| Digestive tract disorders | 56 (25.2%) | 58 (25.6%) | 1.00 | 0.73‐1.38 |
| Diarrhea | 10 (4.5%) | 12 (5.3%) | 0.86 | 0.38‐1.95 |
| Digestive tract disorder NOS | 3 (1.4%) | 1 (0.4%) | 3.07 | 0.32‐29.60 |
| Digestive tract hemorrhage NOS | 0 (0.0%) | 2 (0.9%) | ||
| Emesis | 48 (21.6%) | 42 (18.5%) | 1.26 | 0.85‐1.87 |
| Intestinal disorder NOS | 3 (1.4%) | 2 (0.9%) | 1.85 | 0.82‐4.18 |
| Intestinal stasis | 3 (1.4%) | 2 (0.9%) | 1.53 | 0.37‐6.28 |
| Ear and labyrinth disorders | 4 (1.8%) | 2 (0.9%) | 1.85 | 0.31‐11.11 |
| Eye disorders | 3 (1.4%) | 4 (1.8%) | 0.77 | 0.17‐3.41 |
| Hepatobiliary disorders | 2 (0.9%) | 1 (0.4%) | 2.04 | 0.68‐6.11 |
| Hepatopathy | 1 (0.5%) | 1 (0.4%) | 1.02 | 0.28‐3.66 |
| Immune system disorders | 0 (0.0%) | 1 (0.4%) | ||
| Investigations | 2 (0.9%) | 0 (0.0%) | ||
| Increased blood urea nitrogen or creatinine | 1 (0.5%) | 0 (0.0%) | ||
| Metabolism and nutrition disorders | 1 (0.5%) | 0 (0.0%) | ||
| Musculoskeletal disorders | 8 (3.6%) | 3 (1.3%) | 2.72 | 0.79‐9.38 |
| Lameness | 4 (1.8%) | 1 (0.4%) | 4.06 | 0.78‐21.15 |
| Musculoskeletal disorder NOS | 3 (1.4%) | 1 (0.4%) | 3.07 | 0.32‐29.60 |
| Neurological disorders | 5 (2.3%) | 4 (1.8%) | 1.24 | 0.37‐4.18 |
| Ataxia | 3 (1.4%) | 2 (0.9%) | 1.45 | 0.25‐8.44 |
| Psychological disorders | 1 (0.5%) | 0 (0.0%) | ||
| Renal and urinary disorders | 12 (5.4%) | 6 (2.6%) | 1.88 | 0.69‐5.14 |
| Oliguria | 2 (0.9%) | 0 (0.0%) | ||
| Polyuria | 0 (0.0%) | 1 (0.4%) | ||
| Renal failure | 0 (0.0%) | 1 (0.4%) | ||
| Renal insufficiency | 2 (0.9%) | 0 (0.0%) | ||
| Urine abnormalities | 4 (1.8%) | 2 (0.9%) | 1.85 | 0.31‐11.11 |
| Respiratory tract disorders | 8 (3.6%) | 6 (2.6%) | 1.28 | 0.30‐5.47 |
| Sneezing | 3 (1.4%) | 0 (0.0%) | ||
| Skin and appendages disorders | 10 (4.5%) | 8 (3.5%) | 1.23 | 0.41‐3.66 |
| Pruritus | 3 (1.4%) | 2 (0.9%) | 1.56 | 0.37‐6.58 |
| Skin lesion NOS | 1 (0.5%) | 3 (1.3%) | 0.34 | 0.08‐1.34 |
| Systemic disorders | 31 (14.0%) | 32 (14.1%) | 1.02 | 0.63‐1.65 |
| Abnormal test result | 6 (2.7%) | 7 (3.1%) | 0.89 | 0.34‐2.35 |
| Anorexia | 15 (6.8%) | 10 (4.4%) | 1.47 | 0.65‐3.33 |
| Death | 5 (2.3%) | 3 (1.3%) | 1.51 | 0.30‐7.68 |
| Dehydration | 0 (0.0%) | 2 (0.9%) | ||
| Lethargy | 6 (2.7%) | 15 (6.6%) | 0.44 | 0.18‐1.08 |
| Polydipsia | 3 (1.4%) | 4 (1.8%) | 0.74 | 0.21‐2.59 |
| Weight loss | 4 (1.8%) | 3 (1.3%) | 1.32 | 0.26‐6.67 |
| Unclassifiable adverse event | 3 (1.4%) | 0 (0.0%) | ||
| All adverse events | 106 (47.7%) | 93 (41.0%) | 1.15 | 0.93‐1.43 |
Notes: The relative risk of an adverse event (AE) (robenacoxib/placebo) and 95% CI were estimated using a generalized linear mixed model (GLMM) with no correction for multiple tests. For blank cells, not applicable. Data are shown for every SOC. For PT, variables are shown only if AEs occurred in ≥3 cats (>1%) in either group or if highly relevant to nonsteroidal anti‐inflammatory drugs (NSAIDs) (anemia, digestive tract hemorrhage, hepatopathy, increased blood urea nitrogen or creatinine, oliguria, polyuria, renal failure, renal insufficiency, or dehydration).
Abbreviations: CI, confidence interval; NOS, not otherwise specified; PT, preferred term; SOC, system organ class.