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 12Â 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 3Â months prior to baseline compared to no SRE within 3Â 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 |