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Table 5 Multivariable determinants of adhering to medication in the Zoledronate versus Ibandronate Comparative Evaluation (ZICE) trial

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

Purpose

Variable

Adjusted odds ratio

95% confidence interval

p value

Lower

Upper

Associated with the development of a SRE within 12 months

Gender (female compared to male)

1.29

0.36

4.55

0.697

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

2.19

0.74

6.47

<0.001

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

2.05

0.70

6.00

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

2.35

0.79

7.03

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

3.07

0.95

9.95

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

3.90

1.06

14.31

QLQ-C30 global health domain (per unit increase)

1.00

1.00

1.01

0.358

QLQ-C30 role functioning domain (per unit increase)

1.00

1.00

1.01

0.300

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

1.01

1.01

1.02

0.000

QLQ-C30 dyspnoea domain (per unit increase)

1.00

0.99

1.00

0.547

SRE within the 3 months prior to baseline compared to no SRE within 3 months prior to baseline

1.07

0.79

1.46

0.660

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

0.65

0.45

0.94

0.021

Differentially associated with adherence by trial arm

Orally administered ibandronic acid arm (main effect)

5.77

2.05

16.26

0.001

QLQ-C30 cognitive functioning (main effect)

1.01

1.00

1.02

0.005

Orally administered ibandronic acid arm x QLQ-C30 cognitive functioning (interaction)

0.99

0.98

1.00

0.061

Use of chemotherapy at baseline (main effect)

2.12

1.28

3.53

0.004

Orally administered ibandronic acid arm x Use of chemotherapy at baseline (interaction)

0.47

0.22

1.02

0.057