Table 2

Safety summary at 6 months for washout and direct-switch patients

Patients with AE, n (%)Washout patients (n  =  449)Direct-switch patients (n  =  597)Overall (N  =  1046)
Total patients with AE350 (78.0)473 (79.2)823 (78.7)
Total infections176 (39.2)231 (38.7)407 (38.9)
Discontinuations due to AE17 (3.8)24 (4.0)41 (3.9)
Serious AE50 (11.1)59 (9.9)109 (10.4)
Total serious infections12 (2.7)13 (2.2)25 (2.4)
    Most frequent serious infections
        Pneumonia*04 (0.7)4 (0.4)
        Bronchitis*2 (0.4)1 (0.2)3 (0.3)
        Lobar pneumonia*2 (0.4)02 (0.2)
Discontinuations due to serious AE9 (2.0)8 (1.3)17 (1.6)
Autoimmune disorders4 (0.9)9 (1.5)13 (1.2)
Total neoplasms†8 (1.8)7 (1.2)15 (1.4)
    Total malignancies4 (0.9)2 (0.3)6 (0.6)
        Basal cell carcinoma02 (0.3)2 (0.2)
        Breast cancer2 (0.4)02 (0.2)
        Lung adenocarcinoma1 (0.2)01 (0.1)
        Uterine cancer1 (0.2)01 (0.1)
  • *Most frequent serious infections, reported in more than one patient in the overall population; all others occurred in one patient or fewer overall. †Benign, malignant and unspecified. AE, adverse event.