TABLE 3

Incidence of Adverse Events

Adverse event: system organ class preferred termNo. of patients (%)Highest common toxicity criteria grade (no. of patients)Relationship to 223Ra dichloride: term (no. of patients)
Any adverse event6 (100.0)
Gastrointestinal disorders4 (66.7)
 Nausea2 (33.3)1 (2)Possible (2)
 Abdominal discomfort1 (16.7)1 (1)Possible (1)
 Constipation1 (16.7)1 (1)Unlikely (1)
 Diarrhea1 (16.7)*Probable (1)
Musculoskeletal and connective  tissue disorders3 (50.0)
 Bone pain2 (33.3)1 (2)Unlikely (1)
Probable (1)
 Back pain1 (16.7)1 (1)Unlikely (1)
Blood and lymphatic system  disorders1 (16.7)
 Anemia1 (16.7)2 (1)Possible (1)
General disorders and administration  site conditions3 (50.0)
 Chest pain1 (16.7)3 (1)Possible (1)
 Disease progression1 (16.7)5 (1)*Unlikely (1)
 Fatigue2 (33.3)1 (2)Unlikely (1)
Possible (1)
 Infections and infestations1 (16.7)
 Urinary tract infection1 (16.7)2 (1)Unlikely (1)
 Metabolism and nutrition disorders1 (16.7)
 Anorexia1 (16.7)Possible (1)
  • * One patient died approximately 1 y after first administration, due to disease progression.

  • No common toxicity criteria grade reported; severity was recorded as mild, defined as transient and easily tolerated.