Subgroup Analyses. It is not expected that demographic or baseline characteristics will have an impact on the study results in this study. No subgroup analyses are planned.
Subgroup Analyses. Version: 1.0; CURRENT; Most-Recent; Effective Page 25 of 38 It is not expected that demographic or baseline characteristics will have an impact on the study results in this study. No subgroup analyses are planned.
Subgroup Analyses. The following subgroups have been defined for the primary analysis: ! PIK3CA mutation status (detected/not detected in ctDNA or tissue samples) ! PIK3CA mutation (detected/not detected in ctDNA samples only) ! PIK3CA mutation (detected/not detected in tissue only) ! Age (<=65, >65) ! Region (Asian/Not Asian) ! Visceral disease (Yes/No) ! Prior taxane use in adjuvant/neoadjuvant setting (Yes/No) Where variables are not categorical (e.g. age), cut-offs have been defined to determine subgroup classification. Statistical analysis will be performed when there are a minimum of 10 patients/events in a subgroup. Mutation PIK3CA status (detected/not detected) and sample type (tissue/ctDNA) will be summarised and listed. To investigate the concordance between the results of the two sample types, an analysis will be done using kappa statistics with 95% confidence intervals.
Subgroup Analyses. Subgroup analyses based on age, sex, combined CABG/mitral valve repair patients, isolated mitral valve repair patients, re-do CABG procedure, medical history (e.g., diabetes, hypertension, and anemia), level of LVEF, and baseline right heart pressures, baseline BNP and NT pro-BNP will be performed. Other subgroups may be prespecified in the statistical analysis plan.
Subgroup Analyses. Descriptive statistics for the primary and selected secondary endpoints (to be defined in the SAP) will be provided for the mITT population within each category of the randomisation stratification variables: aetiology of NDO (SCI or MS) and also BTX-A bladder naive and
Subgroup Analyses. It is not expected that demographic or baseline characteristics will have an impact on the study results in this study. No subgroup analyses are planned. Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 01-Mar-2018 Document: TDOC-0054838 Status: Effective Version: 2.0; Most-Recent; Effective; CURRENT
Subgroup Analyses. The results of stratified analyses by selected socio-demographic characteristics revealed no significant heterogeneity in the association between intense and sustained participation in MOVE! and diabetes incidence by gender, race/ethnicity, and age categories (Figure 4.3). However, there were statistically significant differences in the association between participation and diabetes incidence across baseline BMI categories and glucose levels, suggesting greater benefit of participation among those at higher risk for diabetes (with higher BMI or RPG, both p<0.001 for interaction).
Subgroup Analyses. In the lymph node-negative (stage I-II) patients, no significant difference was observed between the BM-negative and BM-positive cases in OS or DFS (Fig. 2); HR 0.85 (95%CI 0.24-3.04), p = 0.80 and HR 1.83 (95%CI 0.66-5.09), p = 0.25, respectively. Also in the group of elderly patients (> 70 years), no significant difference was found between the BM-negative and BM-positive cases in OS (n = 58; p = 0.25) or DFS (n = 49; p = 0.24). Adjustment for sex, age, tumor location and chemotherapy did not change the results for any of these survival analyses. TSR and survival
