Table 3. Listing of most frequently-reported AEs (>15% overall) and all AEs of special interest.
AE, adverse event; GI, gastrointestinal.
| 12-week group (n = 123) | >12-week group (n = 40) | All patients (N = 163) | |
|---|---|---|---|
| Most frequently-reported AEs (>15% of patients overall) | |||
| Influenza-like illness | 47 (38) | 12 (30) | 59 (36) |
| Pruritus | 43 (35) | 12 (30) | 55 (34) |
| Fatigue | 38 (31) | 7 (18) | 45 (28) |
| Asthenia | 29 (24) | 14 (35) | 43 (26) |
| Headache | 32 (26) | 9 (23) | 41 (25) |
| Neutropenia | 24 (20) | 8 (20) | 32 (20) |
| Dry skin | 24 (20) | 5 (13) | 29 (18) |
| Rash | 17 (14) | 7 (18) | 24 (15) |
| Insomnia | 22 (18) | 3 (8) | 25 (15) |
| AEs of special interest (groupings of preferred terms) | |||
| Pruritus (any type) | 44 (36) | 12 (30) | 56 (34) |
| Upper GI symptoms | 27 (22) | 8 (20) | 35 (21) |
| Rash (any type) | 21 (17) | 13 (33) | 34 (21) |
| Neutrophils decrease | 25 (20) | 8 (20) | 33 (20) |
| Anemia | 14 (11) | 9 (23) | 23 (14) |
| Dyspnea | 19 (15) | 4 (10) | 23 (14) |
| Bilirubin increase | 10 (8) | 1 (3) | 11 (7) |
| Photosensitivity | 1 (<1) | 0 | 1 (<1) |