Table 3.
Adverse events and key laboratory measurements (safety population)a
| Inclisiran (n = 98) | Placebo (n = 105) | |
|---|---|---|
| Adverse events, n (%) | ||
| Patients with at least one adverse event | 91 (92.9) | 88 (83.8) |
| Patients with at least one event leading to drug discontinuation | 5 (5.1) | 3 (2.9) |
| Serious adverse events, n (%) | ||
| Patients with at least one serious adverse event | 20 (20.4) | 13 (12.4) |
| Death | 1 (1.0) | 1 (1.0) |
| Cancer | 1 (1.0) | 1 (1.0) |
| New worsening or recurrent malignancy | 5 (5.1) | 2 (1.9) |
| Clinically relevant adverse events at the injection site, n (%) b | ||
| Any event | 4 (4.1) | 0 (0.0) |
| Mild | 3 (3.1) | 0 (0.0) |
| Moderate | 1 (1.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) |
| Persistentc | 0 (0.0) | 0 (0.0) |
| Clinically relevant laboratory measurements, n (%) | ||
| Liver function | ||
| ALT >3× ULN | 1 (1.0) | 1 (1.0) |
| AST >3× ULN | 0 (0.0) | 1 (1.0) |
| ALP >3× ULN | 0 (0.0) | 0 (0.0) |
| Bilirubin 2×ULN | 1 (1.0) | 1 (1.0) |
| Kidney function | ||
| Creatinine >2 mg/dL | 0 (0.0) | 2 (1.9) |
| Muscle | ||
| CK >5×ULN | 3 (3.1) | 1 (1.0) |
| Haematology | ||
| Platelet count <75 × 109/L | 0 (0.0) | 0 (0.0) |
a
The safety population included all the patients who received at least one dose of inclisiran or placebo. Adverse events were recorded over the trial period of 540 days.
b
Adverse events at the injection site included the preferred terms injection site erythema, injection site hypersensitivity, injection site pruritus, injection site rash, and injection site reaction.
c
Events with a duration <6 months were not persistent.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CK, creatine kinase; ULN, upper limit of normal.