TABLE 3.
Signal detection of HLGT for ALK-TKI-associated cardiac disorders a .
| Regimen | HLGT | Heart failures | Coronary artery disorders | Pericardial disorders | Myocardial disorders | Cardiac arrhythmias | Cardiac valve disorders | Cardiac disorders, signs, and symptoms NEC |
|---|---|---|---|---|---|---|---|---|
| ALK-TKIs | N | 137 | 67 | 125 | 28 | 267 | 3 | 50 |
| ROR (95% CI) | 1.64 (1.38, 1.94) | 0.65 (0.51, 0.82) | 6.66 (5.58, 7.95) | 0.80 (0.55, 1.16) | 1.13 (1.00, 1.28) | 0.21 (0.07, 0.67) | 0.41 (0.31, 0.55) | |
| Crizotinib | N | 72 | 28 | 48 | 8 | 126 | 2 | 22 |
| ROR (95% CI) | 2.07 (1.64, 2.61) | 0.65 (0.45, 0.94) | 6.09 (4.58, 8.10) | 0.55 (0.27, 1.10) | 1.28 (1.08, 1.53) | 0.34 (0.09, 1.37) | 0.44 (0.29, 0.67) | |
| Alectinib | N | 31 | 15 | 30 | 6 | 83 | 1 | 9 |
| ROR (95% CI) | 1.37 (0.96, 1.95) | 0.54 (0.32, 0.89) | 5.87 (4.09, 8.41) | 0.64 (0.29, 1.42) | 1.31 (1.05, 1.63) | 0.26 (0.04, 1.88) | 0.28 (0.14, 0.53) | |
| Ceritinib | N | 5 | 8 | 29 | 1 | 24 | 0 | 6 |
| ROR (95% CI) | 0.54 (0.22, 1.30) | 0.71 (0.35, 1.41) | 14.19 (9.81, 20.51) | 0.26 (0.04, 1.86) | 0.92 (0.62, 1.38) | - | 0.45 (0.20, 1.01) | |
| Brigatinib | N | 5 | 7 | 3 | 2 | 16 | 0 | 4 |
| ROR (95% CI) | 0.61 (0.25, 1.48) | 0.7 (0.33, 1.47) | 1.63 (0.52, 5.05) | 0.59 (0.15, 2.38) | 0.70 (0.42, 1.14) | - | 0.34 (0.13, 0.92) | |
| Lorlatinib | N | 24 | 9 | 15 | 11 | 18 | 0 | 9 |
| ROR (95% CI) | 2.72 (1.81, 4.07) | 0.82 (0.42, 1.58) | 7.47 (4.49, 12.42) | 2.99 (1.65, 5.41) | 0.71 (0.45, 1.13) | - | 0.7 (0.37, 1.36) |
a
CI: confidence interval; N: the number of cases, ROR: reporting odds ratio.