Table 2 Adverse events leading to discontinuation in > 2 patients in any single exposure period through 260 weeks of apremilast treatment by treatment period
Patients, n (%) | Apremilast-exposure period* | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Weeks 0 to ≤ 52 | Weeks > 52 to ≤ 104 | Weeks > 104 to ≤ 156 | Weeks > 156 to ≤ 208 | Weeks > 208 to ≤ 260 | ||||||
30 mg twice daily (n = 721) | 20 mg twice daily (n = 720) | 30 mg twice daily (n = 520) | 20 mg twice daily (n = 508) | 30 mg twice daily (n = 443) | 20 mg twice daily (n = 422) | 30 mg twice daily (n = 401) | 20 mg twice daily (n = 366) | 30 mg twice daily (n = 364) | 20 mg twice daily (n = 320) | |
Nausea | 16 (2.2) | 8 (1.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Diarrhea | 15 (2.1) | 6 (0.8) | 1 (0.2) | 0 (0.0) | 0 (0.0) | 1 (0.2) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) |
Headache | 11 (1.5) | 4 (0.6) | 0 (0.0) | 0 (0.0) | 1 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Vomiting | 6 (0.8) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dizziness | 4 (0.6) | 2 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Upper abdominal pain | 3 (0.4) | 4 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |
Migraine | 3 (0.4) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Fatigue | 3 (0.4) | 2 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) |