| . | 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) |
| . | 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) |
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.
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.
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.
| . | 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) |
| . | 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) |
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.
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.
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.
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