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Table 3 Treatment emergent adverse events in radium-223 treated patients according to symptom status

From: Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program

Adverse eventsa Asymptomatic N = 135 Symptomatic N = 548
Grade 1–2 Grade 3–4 Grade 1–2 Grade 3–4
Any 41 (30) 39 (29) 185 (34) 218 (40)
 Anemiab 12 (9) 6 (4) 64 (12) 72 (13)
 Neutropeniac 1 (< 1) 5 (4) 7 (1) 9 (2)
 Thrombocytopeniad 5 (4) 2 (1) 25 (5) 22 (4)
 Constipation 2 (1) 0 23 (4) 6 (1)
 Diarrhea 15 (11) 0 59 (11) 4 (< 1)
 Nausea 15 (11) 0 74 (14) 1 (< 1)
 Vomiting 6 (4) 0 27 (5) 7 (1)
 Asthenia 1 (< 1) 0 22 (4) 2 (< 1)
 Fatigue 14 (10) 1 (< 1) 39 (7) 12 (2)
 General physical health deterioration 0 2 (1) 7 (1) 12 (2)
 Weight decreased 9 (7) 1 (< 1) 34 (6) 5 (< 1)
 Decreased appetite 10 (7) 0 34 (6) 2 (< 1)
 Arthralgia 1 (< 1) 1 (< 1) 20 (4) 1 (< 1)
 Back pain 5 (4) 1 (< 1) 24 (4) 19 (3)
 Bone pain 8 (6) 3 (2) 75 (14) 26 (5)
 Spinal cord compression 0 0 3 (< 1) 19 (3)
  1. Data are number of patients (%) reported in ≥3% in either group and ordered as MedDRA system organ class and preferred terms. Grade 5 TEAEs were reported in 2 (1%) asymptomatic and 32 (6%) symptomatic patients. aReported as MedDRA preferred terms during the treatment period. Combined MedDRA preferred terms: banemia and hemoglobin decreased; cneutropenia and neutrophil count decreased; dthrombocytopenia and platelet count decreased. MedDRA, Medical Dictionary for Regulatory Activities