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. 2016 Feb 15;43(8):869–880. doi: 10.1111/1346-8138.13258

Table 4.

Summary of all‐causality AEs (SAS)

Tofacitinib 5 mg b.i.d., n (%) Tofacitinib 10 mg b.i.d., n (%)
Median duration of exposure, days (range) 365 (139–372) 365 (7–370)
Week 0–16 n = 47 n = 47
AEs 27 (57.4) 28 (59.6)
Serious AEs 0 1 (2.1)
Discontinuations due to AEs 0 1 (2.1)
Most common AEs (≥5% of patients in any group)
Nasopharyngitis 9 (19.1) 8 (17.0)
Headache 1 (2.1) 3 (6.4)
Influenza 3 (6.4) 0
Decreased hemoglobin 0 3 (6.4)
Weeks 0–52 Total n = 94
AEs 78 (83.0)
Serious AEs 4 (4.3)
Discontinuations due to AEs 8 (8.5)
Most common AEs (≥5% of patients)
Nasopharyngitis 28 (29.8)
Herpes zoster (serious and non‐serious) 16 (17.0)
Psoriasis 9 (9.6)
Tinea pedis 9 (9.6)
Influenza 6 (6.4)
Increased blood creatine phosphokinase 5 (5.3)
Decreased hemoglobin 5 (5.3)

AEs occurring up to day 372 are included. Three cases were serious. AEs, adverse events; SAS, safety analysis set.