Table 4.
Information components (IC) calculated for blinatumomab (ND = 4808) for the given adverse reactions
| Reaction Name | NA | NAD | IC | IC025 |
|---|---|---|---|---|
| Inflammatory/Effusive Events | ||||
| C-Reactive Protein Increased | 25,169 | 20 | 2.179 | 1.428 |
| Capillary Leak Syndrome | 1,206 | 8 | 3.616 | 2.404 |
| Myocarditis | 28,484 | 0 | −3.339 | −13.663 |
| Pericarditis | 21,552 | 1 | −1.397 | −5.180 |
| Pericardial Effusion | 17,867 | 11 | 1.775 | 0.751 |
| Cardiac Tamponade | 2,897 | 1 | 0.638 | −3.145 |
| Arrhythmic Events | ||||
| Tachycardia | 202,122 | 61 | 0.905 | 0.480 |
| Atrial Fibrillation | 79,948 | 14 | 0.125 | −0.778 |
| Atrial Flutter | 6,773 | 2 | 0.658 | −1.935 |
| Electrocardiogram QT Prolonged | 27,465 | 5 | 0.168 | −1.394 |
| Ventricular Tachycardia/Ventricular Fibrillation | 27,573 | 3 | −0.489 | −2.559 |
| Cardiac Arrest | 75,180 | 7 | −0.741 | −2.043 |
| Hemodynamic Events | ||||
| Hypotension | 268,722 | 96 | 1.149 | 0.811 |
| Sinus Tachycardia | 14,075 | 7 | 1.446 | 0.144 |
| Cardiomyopathy-Related Events | ||||
| Stress Cardiomyopathy | 2,700 | 0 | −0.899 | −11.222 |
| Ejection Fraction Decreased | 10,708 | 2 | 0.175 | −2.418 |
| Cardiac Failure | 130,976 | 9 | −1.176 | −2.315 |
| Cardiogenic Shock | 7,138 | 2 | 0.606 | −1.987 |
IC025 > 0 is an indicator for significant adverse reaction signals, which are highlighted in bold; ND number of reports containing a given medication in VigiBase; NA number of reports containing a given adverse reaction in VigiBase; NAD number of reports containing a given drug-adverse reaction pair in VigiBase.