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In addition, the identification of predictive factors for developing SREs may be a valuable aid in designing studies to test bone resorption inhibitors that can prevent adverse skeletal events, since an imbalance in these factors when comparing study arms could lead to biased results.
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when comparing study findings.
When comparing the three study arms with the standard office hour appointment arm, attendance at initial appointment was significantly lower for evening appointments (OR=0.756, P<0.001) and slightly lower for Saturday appointments.
As expected, given the small number of women reallocated, the results when comparing arms as originally randomised were very similar to those when comparing arms as finally allocated.
Note that mixed models implicitly correct for baseline differences between patients when comparing the intervention arms.
Further, the proportion of patients who discontinued treatment because of toxicities was almost same when comparing the control arm and the dose-escalated arm.
When comparing the response by study arm (cetuximab vs BSC), the rate was significantly higher with the addition of cetuximab in those with high EREG (16.7% vs 0%, P<0.0001), but not for those with low EREG expression (P=0.25).
Although there were significant changes in HFS, PAID, and ADDQoL scores from baseline to 16 weeks within study arms, there were no differences when comparing the changes in the three study arms.
When compared across arms, a statistically significant difference was observed between the groups (P =.012).
Moreover, there was no significant difference in baseline ALDH1 expression when comparing the two chemotherapy arms.
The widest difference existed when comparing the neck, upper arm, hips, and calves.
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CEO of Professional Science Editing for Scientists @ prosciediting.com