Table 2.

Overall incidences of adverse events occurring in ≥ 10.0% of patients treated with Sipuleucel-T by frequency of occurrence

Any GradeaGrade 3–5a
Preferred termSipuleucel-T (n = 116) n (%)Control (n = 59) n (%)Sipuleucel-T (n = 116) n (%)Control (n = 59) n (%)
Any adverse event111 (95.7)56 (94.9)31 (26.7)18 (30.5)
Fatigue52 (44.8)18 (30.5)0 (0.0))1 (1.7)
Chillsb51 (44.0)6 (10.2)2 (1.7)0 (0.0)
Pyrexiab42 (36.2)1 (1.7)2 (1.7)0 (0.0)
Hot flush30 (25.9)20 (33.9)1 (0.9)1 (1.7)
Headache27 (23.3)8 (13.6)1 (0.9)0 (0.0)
Back pain26 (22.4)8 (13.6)1 (0.9)0 (0.0)
Paraesthesia oral26 (22.4)19 (32.2)0 (0.0)0 (0.0)
Arthralgia25 (21.6)8 (13.6)1 (0.9)0 (0.0)
Myalgiab25 (21.6)5 (8.5)1 (0.9)0 (0.0)
Paraesthesia21 (18.1)10 (16.9)1 (0.9)0 (0.0)
Influenza like illnessb16 (13.8)2 (3.4)0 (0.0)0 (0.0)
Muscle spasms15 (12.9)4 (6.8)0 (0.0)0 (0.0)
Painb15 (12.9)0 (0.0)0 (0.0)0 (0.0)
Constipation14 (12.1)5 (8.5)0 (0.0)0 (0.0)
Upper respiratory tract infection14 (12.1)7 (11.9)0 (0.0)0 (0.0)
Diarrhoea13 (11.2)10 (16.9)0 (0.0)0 (0.0)
Hypertension13 (11.2)8 (13.6)0 (0.0)0 (0.0)
Nausea13 (11.2)4 (6.8)0 (0.0)0 (0.0)
Dizziness12 (10.3)12 (20.3)0 (0.0)0 (0.0)
Nasopharyngitis12 (10.3)6 (10.2)0 (0.0)0 (0.0)
  • aSeverity Grade assessed using National Cancer Institute's Common Toxicity Criteria (version 2.0).

  • bThe incidence of adverse events ≥2-fold greater in the sipuleucel-T arm than in the control arm.