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. 2019 May 10;21:118. doi: 10.1186/s13075-019-1901-3

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)

*Includes all patients who received apremilast during the time interval relative to the start of apremilast treatment