Table 3.
AEs with an Incidence Rate Higher Than 10% in the Pooled Studies (ITT Population)
| AE, n (%) | NP28761 (n = 87) | NP28673 (n = 138) | Difference between Cohorts, % | Pooled Population (N = 225) |
|---|---|---|---|---|
| Patients with ≥1 AE | 84 (97) | 135 (98) | 1 | 219 (97) |
| Constipation | 32 (37) | 53 (38) | 1 | 85 (38) |
| Fatigue | 33 (38) | 43 (31) | 7 | 76 (34) |
| Peripheral edema | 22 (25) | 41 (30) | 5 | 63 (28) |
| Myalgia | 22 (25) | 35 (25) | 0 | 57 (25) |
| Nausea | 21 (24) | 30 (22) | 2 | 51 (23) |
| Cough | 18 (21) | 30 (22) | 1 | 48 (21) |
| Headache | 21 (24) | 26 (19) | 5 | 47 (21) |
| Diarrhea | 20 (23) | 22 (16) | 7 | 42 (19) |
| Dyspnea | 17 (20) | 23 (17) | 3 | 40 (18) |
| Increased aspartate transaminase level | 18 (21) | 18 (13) | 8 | 36 (16) |
| Anemia | 17 (20) | 16 (12) | 8 | 33 (15) |
| Weight increased | 16 (18) | 17 (12) | 6 | 33 (15) |
| Asthenia | 2 (2) | 30 (22) | 20 | 32 (14) |
| Upper respiratory tract infection | 13 (15) | 19 (14) | 1 | 32 (14) |
| Vomiting | 11 (13) | 21 (15) | 2 | 32 (14) |
| Increased alanine transaminase level | 16 (18) | 15 (11) | 7 | 31 (14) |
| Rash | 8 (9) | 22 (16) | 7 | 30 (13) |
| Back pain | 10 (11) | 18 (13) | 2 | 28 (12) |
| Increased blood bilirubin level | 9 (10) | 18 (13) | 3 | 27 (12) |
| Increased blood creatine phosphokinase level | 20 (23) | 6 (4) | 19 | 26 (12) |
| Dizziness | 11 (13) | 15 (11) | 2 | 26 (12) |
| Photosensitivity reaction | 10 (11) | 16 (12) | 1 | 26 (12) |
| Arthralgia | 10 (11) | 15 (11) | 0 | 25 (11) |
| Insomnia | 11 (13) | 12 (9) | 4 | 23 (10) |
| Decreased appetite | 5 (6) | 17 (12) | 6 | 22 (10) |
| Upper abdominal pain | 4 (5) | 17 (12) | 7 | 21 (9) |
| Nasopharyngitis | 3 (3) | 16 (12) | 9 | 19 (8) |
| Increased blood alkaline phosphatase level | 12 (14) | 5 (4) | 10 | 17 (8) |
| Hypokalemia | 9 (10) | 7 (5) | 5 | 16 (7) |
| Oropharyngeal pain | 2 (2) | 14 (10) | 8 | 16 (7) |
| Hypertriglyceridemia | 11 (13) | 0 | 13 | 11 (5) |
AE, adverse event; ITT, intent-to-treat.