Table 3.
Safety analysesa.
| Adverse events | LLDT-8 (1 mg) |
LLDT-8 (0.5 mg) |
Placebo |
|||
|---|---|---|---|---|---|---|
| No. of participants (%) | No. of eventsb | No. of participants (%) | No. of eventsb | No. of participants (%) | No. of eventsb | |
| TEAEs | 41 (89.1) | 195 | 43 (84.3) | 217 | 42 (80.8) | 198 |
| 0 ∼ Wk 24 | 40 (87.0) | 144 | 42 (82.4) | 150 | 40 (76.9) | 130 |
| Wk 24 ∼ Wk 48 | 29 (63.0) | 51 | 23 (45.1) | 67 | 27 (51.9) | 68 |
| TEAEs with grade ≥3 | 11 (23.9) | 14 | 8 (15.7) | 11 | 5 (9.6) | 5 |
| Study drug-related TEAEs | 26 (56.5) | 67 | 19 (37.3) | 46 | 24 (46.2) | 50 |
| Most frequent (≥ 5%) study drug-related TEAEsc | ||||||
| Hyperlipidemiad | 15 (32.6) | 16 | 6 (11.8) | 8 | 5 (9.6) | 7 |
| Increased ALT | 4 (8.7) | 4 | 7 (13.7) | 10 | 2 (3.8) | 2 |
| Decreased WBC | 5 (10.9) | 5 | 5 (9.8) | 5 | 1 (1.9) | 1 |
| Decreased neutrophil | 7 (15.2) | 8 | 2 (3.9) | 2 | 0 | 0 |
| Increased GGT | 2 (4.3) | 2 | 3 (5.9) | 3 | 2 (3.8) | 2 |
| Hepatic steatosis | 4 (8.7) | 4 | 0 | 0 | 1 (1.9) | 1 |
| Related TEAEs with grade ≥3 | 4 (8.7) | 4 | 1 (2.0) | 1 | 1 (1.9) | 1 |
| TEAEs leading to discontinuation | 0 | 0 | 1 (2.0) | 1 | 0 | 0 |
| Related TEAEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 | 0 |
| SAEs | 0 | 0 | 2 (3.9) | 2 | 1 (1.9) | 1 |
| 0 ∼ Wk 24 | 0 | 0 | 2 (3.9) | 2 | 0 | 0 |
| Wk 24 ∼ Wk 48 | 0 | 0 | 0 | 0 | 1 (1.9) | 1 |
| Study drug-related SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
The analyses were set for the SAS population. Related TEAE category includes Possible, Probable, or Definite TEAEs which was presumed to be associated with study drug. TEAE denotes treatment-emergent adverse event; ALT, alanine transaminase; WBC, white blood cell; GGT, gamma-glutamyl transferase; SAE, serious adverse event.
No. of events was defined as the number of occurrences of adverse events. Same adverse events in a participant at a consecutive time would be counted only once.
Study drug-related TEAEs with an incidence rate ≥5% among the three groups were listed and generalized as preferred terms (PTs) according to MedDRA 24.0. PTs were ranked in descending order of the total number among the SAS population. The normal range of ALT was 9–50 U/L for male and 7–40 U/L for female; the normal range of WBC was 4.00–10.00×109/L; the normal range of neutrophil was 2.00–7.50×109/L; and the normal range of GGT was 10–60 U/L for male and 7–45 U/L for female.
Definition of hyperlipidemia included hypercholesterolemia, hypertriglyceridemia, and the elevated concentrations of both cholesterol and triglyceride. The normal range of cholesterol was 2.85–5.70 mmol/L and normal range of triglyceride was 0.45–1.70 mmol/L. The incidence rates of hypercholesterolemia were 15.2% (7/46) at HT8 group, 5.9% (3/51) at LT8 group, and 5.8% (3/52) at placebo group. The incidence rates of hypertriglyceridemia were 4.3% (2/46) at HT8 group, 2.0% (1/51) at LT8 group, and 7.7% (4/52) at placebo group.