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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