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Patients in both arms were evaluated for tumour response or progression every 8 weeks.
In addition, the toxicities of both arms were evaluated at the conclusion of the phase II component.
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This effect was independently observed also when the treatment arms were evaluated separately (Tables 3C and D).
The number of entries and the percentage of time spent in the open arms were evaluated as anxiety index.
Differences between the two arms were evaluated using a two-sample t-test for continuous variables and Pearson's chi-square test was used for categorical data.
The efficacy and toxicity of the two arms were evaluated by comparing response rate, DCR, and incidence of toxicity using Pearson's chi-square tests, while TTP and OS were compared by log-rank tests.
Differences in pharmacokinetic parameters between the four treatment arms were evaluated using one-way analysis of variance (ANOVA) combined with least significant difference (LSD) method (P was set at 0.05) and the Student's t-test was used to calculate the P-value of significant differences.
There were seven RCTs (Shildt et al, 1983; Dowell et al, 2001; Assersohn et al, 2003; Culine et al, 2003; Palmeri et al, 2006; Huebner et al, 2009; Hainsworth et al, 2010) and one non-randomised trial (Saghatchian et al, 2001) where two treatment arms were evaluated.
Studies that included multiple intervention arms were considered effective if any of the CCDSS based treatment arms was evaluated as effective.
Baseline comparability between the treatment arms was evaluated by summarising and comparing means and standard deviations (SDs) for continuous variables or numbers and percentages for categorical variables.
Clinical events by study arm were evaluated by confirmed entry diagnoses in a post-hoc analysis.
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