Table 5.
AEs related to renal disorders and cardiac disorders according to the safety specifications listed in the risk management plan, and causal relationship to letermovir (safety analysis set; N = 821)
| AEs | Total AEsa | Serious AEsa | Non-serious AEsa | ||||
|---|---|---|---|---|---|---|---|
| Total | Unrelated | Relatedb | Unrelated | Relatedb | Unrelated | Relatedb | |
| Renal disorders | |||||||
| During IV letermovir (n = 15/225 [6.67%]) | |||||||
| Renal dysfunction | 8 | 4 | 4 | 3 | 1 | 1 | 3 |
| Blood creatinine increased | 4 | 0 | 4 | 0 | 0 | 0 | 4 |
| Acute kidney injury | 2 | 0 | 2 | 0 | 1 | 0 | 1 |
| Renal failure | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| During oral letermovir (n = 34/790 [4.30%]) | |||||||
| Renal impairment | 15 | 7 | 8 | 3 | 0 | 4 | 8 |
| Cystitis hemorrhagic | 6 | 6 | 0 | 2 | 0 | 4 | 0 |
| Acute kidney injury | 4 | 3 | 1 | 3 | 1 | 0 | 0 |
| Renal dysfunction | 3 | 3 | 0 | 1 | 0 | 2 | 0 |
| Blood creatinine increased | 2 | 2 | 0 | 0 | 0 | 2 | 0 |
| Chronic kidney disease | 2 | 2 | 0 | 2 | 0 | 0 | 0 |
| Renal failure | 2 | 2 | 0 | 1 | 0 | 1 | 0 |
| Tubulointerstitial nephritis | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Cardiac disordersc (n = 25 [3.05%]) | |||||||
| Acute heart failure | 4 | 4 | 0 | 4 | 0 | 0 | 0 |
| Atrial fibrillation | 3 | 2 | 1 | 1 | 0 | 1 | 1 |
| Congestive heart failure | 3 | 3 | 0 | 3 | 0 | 0 | 0 |
| Acute myocardial infarction | 2 | 2 | 0 | 2 | 0 | 0 | 0 |
| Cardiomyopathy | 2 | 0 | 2 | 0 | 0 | 0 | 2 |
| Cardiac disorder | 2 | 1 | 1 | 1 | 0 | 0 | 1 |
| Cardiac dysfunction | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Chronic heart failure | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Decreased blood pressure | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Heart failure | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Increased blood pressure | 1 | 0 | 1 | 0 | 0 | 0 | 1 |
| Pericardial effusion | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Pericarditis | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Prinzmetal angina | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Supraventricular tachycardia | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| Ventricular fibrillation | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Ventricular tachycardia | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
AEs adverse events, IV intravenous
aValues are number of patients
bConsidered causally related to letermovir (i.e., adverse drug reactions)
cCombined for IV and oral letermovir