Table 4.
Log OR (95% CI) and p values for TRAEs reported in at least 5% of patients in any arm of CELESTIAL or REACH-2 (cabozantinib vs. ramucirumab)
| TRAE | Unmatched analysis | Matched-adjusted analysis | ||
|---|---|---|---|---|
| Log OR (95% CI) | p value | Log OR (95% CI) | p value | |
| Any grade | ||||
| Increased AST | −0.50 (−2.32, 1.32) | 0.6019 | −0.58 (−2.59, 1.42) | 0.5799 |
| Diarrhea | 1.61 (0.23, 2.99) | 0.0220 | 1.53 (0.00, 3.05) | 0.0499 |
| Fatigue | −0.05 (−1.29, 1.18) | 0.9377 | 0.44 (−0.89, 1.76) | 0.5288 |
| Decreased appetite | 0.66 (−0.72, 2.05) | 0.3519 | 1.10 (−0.46, 2.66) | 0.1691 |
| Vomiting | 1.05 (−1.58, 3.69) | 0.4430 | −0.90 (−3.06, 1.27) | 0.4247 |
| Hypertension | 1.92 (−0.33, 4.16) | 0.0942 | 2.52 (0.23, 4.81) | 0.0305 |
| Nausea | −0.33 (−2.17, 1.52) | 0.7413 | −0.15 (−2.27, 1.97) | 0.8968 |
| Proteinuriaa | −2.11 (−3.52, −0.70) | 0.0034 | −1.78 (−2.99, −0.56) | 0.0043 |
| Grade 3/4 | ||||
| Increased ASTa | 2.28 (1.02, 3.55) | 0.0004 | 1.79 (0.47, 3.11) | 0.0078 |
| Fatiguea | 2.24 (0.70, 3.77) | 0.0044 | 2.72 (1.23, 4.22) | 0.0004 |
| Hypertension | 16.34 (14.73, 17.94) | < 0.0010 | 16.92 (15.20, 18.65) | < 0.0010 |
| Leading to discontinuation | ||||
| Any TRAE | 0.40 (−1.57, 2.36) | 0.7509 | 1.16 (−0.89, 3.20) | 0.2709 |
AST aspartate aminotransferase, CI confidence interval, OR odds ratio, TRAE treatment-related adverse event
aUnanchored analysis because no AEs occurred in at least one of the placebo arms of the trials