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Table 3 Top reasons for discontinuation during FREEDOM and during the Extension

From: Influence of subject discontinuation on long-term nonvertebral fracture rate in the denosumab FREEDOM Extension study

 

FREEDOM

(Years 1–3)

Extension year 5

(Years 1–5)

Placebo

(N = 3906)

Denosumab

(N = 3902)

Crossover denosumab

(N = 2207)a

Long-term denosumab

(N = 2343)a

Reasons for discontinuation, n (%)

700 (18)

630 (16)

745 (34)

801 (34)

 Consent withdrawn

403 (10)

344 (9)

325 (15)

337 (14)

 Other

20 (1)

32 (1)

170 (8)b

184 (8)b

 Adverse event

81 (2)

93 (2)

93 (4)

115 (5)

 Death

78 (2)

62 (2)

64 (3)

80 (3)

 Lost to follow-up

57 (1)

57 (1)

60 (3)

46 (2)

  1. aPublished in Papapoulos et al 2012 [2]
  2. bIncludes discontinuation after a protocol amendment to extend the Extension for an additional 5 years, which was associated with an increased discontinuation rate at the end of Extension year 2