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After obtaining approval by local institutional review boards, individual cytogenetic and epidemiological data from the original cohorts were collected and entered in a pooled database.
Here, we report findings of a retrospective analysis using a pooled database of patients from these six trials in which we compared the efficacy and safety of sunitinib in patients aged <70 or ⩾70 years.
In all, 168 T1–3, N0 1, HER-2-positive patients were identified from a pooled database, classified by the 70-gene signature as good or poor prognosis, and correlated with long-term outcome.
Individual datasets from six prospective MIBG cohort studies performed in Japan between 1990 and 2009 were combined to make a pooled database of 1,322 CHF patients as previously reported [ 5, 13– 13].
A pooled database of individual patient data from eight previously reported trials of exenatide QW was used to integrate safety data for 4,328 patients with type 2 diabetes treated for 24 or 30 weeks (blinded-comparator period).
We have previously developed a risk prediction tool (SCOPEX) based on a range of demographic and baseline parameters from a pooled database of BUD/FORM COPD studies; data from this tool showed that higher mean daily reliever use was a dominant predictor of a COPD exacerbation in the next 6 months [ 27].
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The aims of this study were to analyze factors for predicting cardiac death and to create a prediction model incorporating MIBG imaging based on the Japanese multicenter pooled database.
We do not make our analysis using directly the pooled database since all the control explanatory variables are not available in each waves, which is a limitation of this database.
The model for OS was developed based on the 888 patients pooled database, of which 556 (63%) died during the observation period.
The large size of the pooled database allowed us to investigate in greater detail hypotheses not properly tested in the original studies, in particular, whether the frequency of chromosome-type and chromatid-type aberrations has a different predictive value for cancer risk.
In majority of the reports comparing outcomes between participants and non-participants of clinical trials, however, the non-participant 'controls' were chosen from differently pooled database, which could include baseline imbalances between groups and hindsight bias (Davis et al, 1985; Braunholtz et al, 2001; Peppercorn et al, 2004).
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