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While these SFK inhibitors have generally been well-tolerated with limited toxicity and good efficacy in hematological malignant diseases, efficacy in phase II clinical trials in different solid tumor indications have been modest.
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The clinical end-points used to establish disease efficacy in breast cancer trials were reviewed by Matt Ellis.
There was a statistically significant relationship between time and chronic disease efficacy (p = 0.032) and between time and fatigue (p = 0.003).
There was also a greater improvement in mental functioning for subjects with high fatigue (p =0.003) and low chronic disease efficacy at baseline (p = 0.032).
For women with advanced disease, efficacy after first-line taxane-based regimens is extremely poor (Dellinger and Monk, 2009; Dizon, 2010).
By using the BIPEDS (Burden of disease, Investigative, Prognostic of disease, Efficacy of intervention, Diagnostic of disease, and Safety of intervention) classification of OA biomarkers [ 14, 46], we showed that SF ARGS can be categorized as a diagnostic marker for disease with the capability of distinguishing a knee injured up to 1 year after injury from knees of healthy controls [ 10].
Low fatigue (p = 0.001) and high chronic disease-efficacy (p = 0.004) predicted higher mental functioning.
Efficacy for managing chronic disease (Chronic disease-efficacy) was measured by the Self-Efficacy for Managing Chronic Disease 6-Item Scale [ 23].
Data were dichotomized into high and low chronic disease-efficacy and fatigue around the means of 6.55 and 49.37, respectively.
Furthermore, subjects with higher chronic disease-efficacy (p = 0.007) as well as lower levels of pain (p < 0.001) also had better physical functioning (Table 2).
There was a statistically significant interaction between disability and time (p = 0.040) and between chronic disease-efficacy and time (p = 0.036).
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