Table 1. Information component (IC) and its 95% credibility interval lower endpoint (IC025) comparing cardiovascular immune related adverse events (CV-irAE) associated to overall immunotherapy vs. full database from VigiBase (from inception in 1967 to 01/2018).
A positive IC025 value (>0) is the traditional threshold used in statistical signal detection with VigiBase. Results that are statistically significant are in bold.
| Overall immunotherapy | Full database (starting 1967) | IC / IC025 | ||
|---|---|---|---|---|
| Total number of ICSRs available | 31,321 | 16,343,451 | ||
| Number of ICSRs by CV-irAE subgroups | ||||
| Myocarditis | 122 (0.39%) | 5,515 (0.03%) | 3.47/3.2 | |
| Pericardial diseases | 95 (0.3%) | 12,800 (0.08%) | 1.93/1.63 | |
| Cardiac supra-ventricular arrhythmias | 222 (0.71%) | 68,597 (0.42%) | 0.75/0.56 | |
| Vasculitis | 82 (0.26%) | 33,289 (0.2%) | 0.36/0.03 | |
| - Polymyalgia rheumatica | 16 (0.05%) | 1709 (0.01%) | 2.12/1.33 | |
| Heart Failure | 225 (0.72%) | 142,502 (0.87%) | −0.28/−0.47 | |
| Cerebral hemorrhage | 250 (0.8%) | 179,621 (1.1%) | −0.46/−0.65 | |
| Endocardial disorders | 8 (0.03%) | 3,149 (0.02%) | 0.38/−0.79 | |
| Hemorrhage (clinical events) | 1,023 (3.27%) | 875,398 (5.36%) | −0.71/−0.80 | |
| Cerebral arterial ischemia | 195 (0.62%) | 161,618 (0.99%) | −0.67/−0.88 | |
| Cardiac conductive disorders | 37 (0.12%) | 26,008 (0.16%) | −0.42/−0.93 | |
| Myocardial infarction | 167 (0.53%) | 163,908 (1%) | −0.91/−1.14 | |
| Biological hemostatic disorders favoring hemorrhage | 135 (0.43%) | 136,474 (0.84%) | −0.95/−1.21 | |
| Arterial systemic ischemia | 203 (0.65%) | 215,741 (1.32%) | −1.02/−1.23 | |
| Cardiac death or shock | 136 (0.43%) | 144,825 (0.89%) | −1.03/−1.28 | |
| Hypertension and related end-organ damages | 198 (0.63%) | 239,232 (1.46%) | −1.2/−1.42 | |
| Vascular neoplasm | 4 (0.01%) | 2,687 (0.02%) | −0.33/−2.06 | |
| Torsade de pointes / Long QT | 22 (0.07%) | 31,642 (0.19%) | −1.44/−2.11 | |
| Cardiac ventricular arrhythmias | 22 (0.07%) | 33,504 (0.2%) | −1.52/−2.19 | |
| Pulmonary hypertension and related cardiac involvement | 17 (0.05%) | 30,718 (0.19%) | −1.76/−2.53 | |
| Cardiac valve disorders | 2 (0.01%) | 25,500 (0.16%) | −4.3/−6.89 | |
| Dyslipidemia | 20 (0.06%) | 64,555 (0.39%) | −2.6/−3.3 | |
Overall immunotherapy: Any individual case safety reports related to nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, ipilimumab or tremelimumab.