Table 2.
Treatment-emergent AEs and grade 3–4 laboratory abnormalities
| All patients | Treatment-naïve patients | ||
|---|---|---|---|
| Incidence, [n (%)] | Week 24 analysis | Week 48 analysis | Week 48 analysis |
| N = 313 | N = 313 | N = 295 | |
| Grade 3–4 AEs | 18 (6) | 24 (8) | 21 (7) |
| Any AE | 275 (88) | 286 (91) | 270 (92) |
| Any drug-related AE | 123 (39) | 128 (41) | 122 (41) |
| Serious AEs | 15 (5) | 26 (8) | 21 (7) |
| Deaths | 0 | 0 | 0 |
| AEs any grade, regardless of relationship to study treatment and occurring in ≥10% of patients | |||
| Diarrhea | 78 (25) | 86 (27) | 80 (27) |
| Nausea | 67 (21) | 72 (23) | 69 (23) |
| Upper respiratory tract infection | 31 (10) | 44 (14) | 43 (15) |
| Headache | 29 (9) | 38 (12) | 35 (12) |
| AEs leading to discontinuation* | |||
| Any, n | 15 (5) | 16 (5) | 16 (5) |
| Maculo-papular rash | 3 (1) | 3 (1) | 3 (1) |
| Rash | 3 (1) | 3 (1) | 3 (1) |
| Nausea | 2 (0.6) | 2 (0.6) | 2 (0.7) |
| Hypersensitivity | 2 (0.6) | 2 (0.6) | 2 (0.7) |
| Idiopathic thrombocytopenic purpura | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Dyspepsia | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Vomiting | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Mycobacterium avium complex infection | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Headache | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Dysgeusia | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Renal tubular disorder | – | 1 (0.3) | 1 (0.3) |
| Allergic dermatitis | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Macular rash | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Vesicular rash | 1 (0.3) | 1 (0.3) | 1 (0.3) |
| Treatment-emergent grade 3–4 laboratory abnormalities occurring in ≥2% patients | |||
| n = 310 | n = 310 | n = 292 | |
| Increased creatine kinase | 18 (6) | 22 (7) | 22 (8) |
| Increased alanine amino transferase | 7 (2) | 9 (3) | 9 (3) |
| Increased aspartate amino transferase | 6 (2) | 8 (3) | 7 (2) |
| Increased amylase | 6 (2) | 8 (3) | 7 (2) |
| Increased lipase | 5 (2) | 7 (2) | 7 (2) |
N number of patients; n number of patients with observations; AE adverse event. Serious AEs included any AE that occurred at any dose that resulted in death, a life-threatening situation, inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received investigational medicinal product; *Patients may have discontinued due to more than 1 AE.