Table 2 Incidence of ADRs, serious ADRs and ADRs by the SOC classification
ADRsSerious ADRs
PMS (95% CI)Japanese clinical trial12 (95% CI)PMS (95% CI)Japanese clinical trial12 (95% CI)
No. of investigated cases50001415000141
Patient years2359.34131.642359.34131.64
No. of cases with ADRs14019530815
Incidence rate of ADRs (%)28.067.46.210.6
ADRs (per 100 patient-years)59.38 (59.07 to 59.69)72.16 (70.71 to 73.61)13.05 (12.90 to 13.20)11.39 (10.81 to 11.97)
Category of ADRs classified by the SOC* (per 100 patient-years)
    Blood and lymphatic system disorders0.38 (0.36 to 0.41)1.52 (1.31 to 1.73)0.25 (0.23 to 0.27)
    Cardiac disorders1.19 (1.15 to 1.23)3.80 (3.47 to 4.13)0.21 (0.19 to 0.23)
    Ear and labyrinth disorders0.08 (0.07 to 0.09)2.28 (2.02 to 2.54)0.76 (0.61 to 0.91)
    Endocrine disorders0.04 (0.03 to 0.05)1.52 (1.31 to 1.73)0.04 (0.03 to 0.05)0.76 (0.61 to 0.91)
    Eye disorders0.30 (0.28 to 0.32)3.04 (2.74 to 3.34)
    Gastrointestinal disorders5.26 (5.17 to 5.35)19.75 (18.99 to 20.51)0.55 (0.52 to 0.58)1.52 (1.31 to 1.73)
    Systemic disorders administration site conditions11.66 (11.52 to 11.80)29.62 (28.69 to 30.55)1.10 (1.06 to 1.14)0.76 (0.61 to 0.91)
    Hepatobiliary disorders3.86 (3.78 to 3.94)0.76 (0.61 to 0.91)0.04 (0.03 to 0.05)
    Immune system disorders0.42 (0.39 to 0.45)1.52 (1.31 to 1.73)0.42 (0.39 to 0.45)
    Infections and infestations18.35 (18.18 to 18.52)39.50 (38.43 to 40.57)8.56 (8.44 to 8.68)8.36 (7.87 to 8.85)
    Laboratory tests9.45 (9.33 to 9.57)3.04 (2.74 to 3.34)0.59 (0.56 to 0.62)
    Metabolic and nutritional disorders0.34 (0.32 to 0.36)1.52 (1.31 to 1.73)
    Musculoskeletal and connective tissue disorders1.61 (1.56 to 1.66)1.52 (1.31 to 1.73)0.25 (0.23 to 0.27)
    Neoplasm benign, malignant and unspecified0.38 (0.36 to 0.41)1.52 (1.31 to 1.73)0.38 (0.36 to 0.41)0.76 (0.61 to 0.91)
    Nervous system disorders8.10 (7.99 to 8.22)15.95 (15.27 to 16.63)0.34 (0.32 to 0.36)0.76 (0.61 to 0.91)
    Psychiatric disorders0.13 (0.12 to 0.14)0.04 (0.03 to 0.05)
    Renal and urinary disorders0.51 (0.48 to 0.54)3.80 (3.47 to 4.13)0.04 (0.03 to 0.05)0.76 (0.61 to 0.91)
    Reproductive system and breast disorders0.08 (0.07 to 0.09)0.04 (0.03 to 0.05)
    Respiratory, thoracic and mediastinal disorders5.98 (5.88 to 6.08)25.07 (24.22 to 25.93)1.70 (1.65 to 1.75)1.52 (1.31 to 1.73)
    Skin and subcutaneous tissue disorders13.44 (13.29 to 13.59)17.47 (16.76 to 18.18)0.34 (0.32 to 0.36)
    Surgical and medical procedures0.76 (0.61 to 0.91)
    Vascular disorders4.87 (4.78 to 4.96)3.80 (3.47 to 4.13)0.13 (0.12 to 0.14)0.76 (0.61 to 0.91)
  • *ADRs were classified using the system organ class (SOC) according to the Medical Dictionary for Regulatory Affairs (MedDRA; version 7.1).