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. Author manuscript; available in PMC: 2014 Feb 1.
Published in final edited form as: Cancer Treat Rev. 2012 Aug 13;39(1):97–104. doi: 10.1016/j.ctrv.2012.07.002

Table 6.

Adverse Events

Outcome Denosumab
n/N
Bisphosphonates
n/N
Pooled
relative
risk (RR)
95%CI P value I2
CTCAE grade 3 AE28,
32-36, 42
2,041/3,170 2,003/2,926 0.97 0.89,1.0 0.51 74%
AE-associated
hospitalization28, 32-36, 42
1,575/3,176 1,646/2,930 0.95 0.91,1.0 0.04 0%
AE leading to Rx
discontinuation28, 32-36, 42
336/3,176 402/2,942 0.82 0.72, 0.94 0.005 0%
Acute phase reactions28,
32-36, 42
264/3,170 586/2,939 0.42 0.37, 0.49 <0.00001 37.9
%
Renal toxicity33-36 262/2,841 335/2,836 0.76 0.59, 0.98 0.03 61%
Hypocalcemia28, 32-36, 42 295/3,170 143/2,926 1.9 1.6, 2.3 <0.00001 0%
New cancers34-36 28/2,841 18/2,836 1.6 0.86, 2.8 0.14 0%
Infections28, 33-36 1,474/3,125 1,646/2,930 1.0 0.93, 1.1 0.76 48%
ONJ32, 34-36 52/2,885 37/2,846 1.4 0.92, 2.1 0.11 0%

AE, adverse events; Rx, treatment; ONJ, osteonecrosis of jaw.