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Table 4 Multivariable determinants of outcome in the Zoledronate versus Ibandronate Comparative Evaluation (ZICE) trial (odds of experiencing a skeletal-related event during the first 12 months)

From: The use of randomisation-based efficacy estimators in non-inferiority trials

Variable

Adjusted odds ratio

95% Confidence interval

p value

Lower

Upper

Gender (female compared to male)

0.23

0.06

0.88

0.032

18.5 kg/m2 < BMI ≤ 25 kg/m2 (normal/healthy weight) compared to ≤ 18.5 kg/m2 (underweight)

6.16

0.75

50.65

<0.001

25 kg/m2 < BMI ≤ 30 kg/m2 (overweight) compared to ≤ 18.5 kg/m2 (underweight)

6.85

0.84

56.13

30 kg/m2 < BMI ≤ 35 kg/m2 (moderately obese) compared to ≤ 18.5 kg/m2 (underweight)

13.17

1.59

108.81

35 kg/m2 < BMI ≤ 40 kg/m2 (severely obese) compared to ≤ 18.5 kg/m2 (underweight)

6.99

0.81

60.39

BMI > 40 kg/m2 (very severely obese) compared to ≤ 18.5 kg/m2 (underweight)

13.11

1.44

119.65

QLQ-C30 global health domain (per unit increase)

0.98

0.98

0.99

0.001

QLQ-C30 role functioning domain (per unit increase)

1.01

1.00

1.02

0.005

QLQ-C30 nausea / vomiting domain (per unit increase)

1.01

1.01

1.02

<0.001

QLQ-C30 dyspnoea domain (per unit increase)

0.99

0.99

1.00

0.056

SRE within the three months prior to baseline compared to no SRE within three months prior to baseline

1.56

1.14

2.13

0.006

Recent use of pain medication at baseline compared to no recent use of pain medication

1.63

1.08

2.46

0.019