Subgroup Analyses Sample Clauses

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.
Sample 1Sample 2
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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.
Sample 1
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.
Sample 1
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).
Sample 1
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
Sample 1
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
Sample 1
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
Sample 1
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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.
Sample 1

Related to Subgroup Analyses

  • Special Analyses It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that it is unlikely that a substantial number of small entities will hold REMIC residual interests. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that sections 553(b) and 553(d) of the Administrative Procedure Act (5 U.S.C. chapter 5) do not apply to these regulations. Drafting Information The principal author of these regulations is Xxxxxxxx Xxxxxxxxxx. However, other personnel from the IRS and Treasury Department participated in their development. List of Subjects 26 CFR Part 1 Income taxes, Reporting and record keeping requirements.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Budgets, etc No more than 60 days after the commencement of each fiscal year of the Parent, budgets of and for the Parent and its Subsidiaries in reasonable detail for each of the four fiscal quarters of such fiscal year and an annual budget for the immediately succeeding fiscal year, in each case as customarily prepared by management for its internal use setting forth, with appropriate discussion, the principal assumptions upon which such budgets are based. Together with each delivery of financial statements pursuant to Section 5.01(b) and (c), a comparison of the current year to date financial results (other than in respect of the balance sheets included therein) against the budgets required to be submitted pursuant to this clause (d) shall be presented.

  • Income Tax Return Information Each Company will provide to the other Company information and documents relating to their respective Groups required by the other Company to prepare Tax Returns. The Responsible Company shall determine a reasonable compliance schedule for such purpose in accordance with Distributing Co.'s past practices. Any additional information or documents the Responsible Company requires to prepare such Tax Returns will be provided in accordance with past practices, if any, or as the Responsible Company reasonably requests and in sufficient time for the Responsible Company to file such Tax Returns on a timely basis.

  • Statistical and Market Data Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included in the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.

  • Annual Tax Information The Managers shall cause the Company to deliver to the Member all information necessary for the preparation of the Member’s federal income tax return.

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

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