Table 3 TAEAs through 52 weeks
2 mg morning (n = 29, PY 19.9) E (E/100 PY) | 2 mg evening (n = 30, PY 24.9) E (E/100 PY) | 4 mg morning (n = 27, PY 19.4) E (E/100 PY) | 4 mg evening (n = 28, PY 22.8) E (E/100 PY) | |
|---|---|---|---|---|
Any TEAE | 29 (145.7) | 35 (140.6) | 30 (154.6) | 37 (162.3) |
Serious TEAE | 0 (0) | 2 (8.0) | 1 (5.2) | 2 (8.8) |
TEAE leading to discontinuation of study drug | 1 (5.0) | 2 (8.0) | 0 | 2 (8.8) |
Death | 0 | 0 | 0 | 0 |
TEAEs of special interest | ||||
Infection | 5 (25.1) | 5 (20.1) | 8 (41.2) | 11 (48.2) |
Serious infection | 0 | 0 | 0 | 2 (8.8) |
Herpes zoster | 2 (10.1) | 1 (4.0) | 1 (5.2) | 1 (4.4) |
Active TB | 0 | 0 | 0 | 1 (4.4) |
Malignancy | 0 | 1 (4.0) | 0 | 0 |
Adjudicated MACEs | 0 | 0 | 0 | 0 |
Adjudicated VTE | 0 | 0 | 0 | 0 |
CPK elevation | 5 (25.1) | 5 (20.1) | 5 (25.8) | 6 (26.3) |
Anemia (Hb < 110 g/L) | 5 (25.1) | 5 (20.1) | 3 (15.5) | 7 (30.7) |
Hb change from baseline | ||||
Grade 3 (decrease 21–29 or Hb ≥ 70 to < 80 g/L) | 1 (5.0) | 0 | 3 (15.5) | 1 (4.4) |
Grade 4 (decrease 30 or Hb < 70 g/L) | 1 (5.0) | 1 | 0 | 0 |
Lymphopenia (< 1,000 /µL) | 4 (20.1) | 6 (24.1) | 6 (30.9) | 5 (21.9) |
Neutropenia (< 1,000 /µL) | 0 | 0 | 0 | 1 (4.4) |
Hepatic disorder* | 4 (20.1) | 4 (16.1) | 5 (25.8) | 5 (21.9) |
Renal dysfunction† | 1 (5.0) | 0 | 0 | 1 (4.4) |