Subgroup analysis of a phase IIB trial

Subgroup analysis from a phase II trial of ponatinib and ...

The combination of ponatinib and blinatumomab is an effective and well-tolerated chemotherapy-free regimen for pts with R/R Ph+ ALL.

Efficacy and safety of anlotinib in advanced leiomyosarcoma

Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203) · Abstract · Article metrics · Related Articles.

Statistical Considerations for Subgroup Analyses - PMC

Dmitrienko A, Muysers C, Fritsch A, & Lipkovich I (2016). General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials.

Subgroup analyses and updated overall survival from the phase II ...

4553Background: In the randomized phase 2 study of LEN, EVE, and LEN+EVE in mRCC, LEN+EVE significantly improved the primary endpoint median ...

Subgroup Analysis in Clinical Trials - Penn CCEB

• Phase I/II clinical trials - small samples sizes, research grade biomarker assays, earlier endpoints (e.g., tumor response), heterogeneous ...

A global Phase IIb study of linerixibat for the treatment of cholestatic ...

Japanese subgroup analysis of GLIMMER: A global Phase IIb study of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary ...

22MO Efficacy and safety of sacituzumab govitecan in Chinese ...

... Subgroup analysis from a phase IIb trial. B. Xu. B. Xu. Affiliations. Oncology ... In this subgroup analysis, HER2 status of the most recent tumor biopsy ...

How to understand subgroup analysis in clinical studies

Lancet 1988; ii: 349–60. 791. (9.2%). 0. 7 14 21 28 35. 50. 600 ... Subgroup Analyses in Reporting of Phase III Clinical Trials in. Solid Tumors.

Differential Treatment Effects of Subgroup Analyses in Phase 3 ...

Phase 3 trials are usually not powered for subgroup analyses, which increases the risk of type II error; furthermore, repeated inferential ...

What a Clinician Ought to Know: Subgroup Analyses

Large randomized phase III prospective studies continue ... Subgroup analyses are useful in endeavoring to obtain maximum information from a clinical trial ...

Adjusted significance levels for subgroup analyses in clinical trials

... trial to the patients that belong to the subgroup. This could be done in the inclusion criteria. For example, [2] show results of a Phase II clinical trial ...

Subgroup analyses in confirmatory clinical trials: time to be specific ...

Subgroup analyses constitute a fundamental step in the assessment ... Phase III pivotal trial based on a Phase II result. Based on the ...

Don't Design Phase III Trials Based on Retrospective Subgroup ...

In the phase II study of E10030, a total of 449 subjects were randomized 1:1:1 between 3 monthly treatment arms that included 0.3 mg E10030 plus ranibizumab ( ...

Statistical Considerations for Subgroup Analyses

Type II error rate: the probability of ... General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials.

Subgroup analyses in randomized controlled trials frequently ...

General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials 2016 ... subgroup analysis from phase II study. Cancer Sci, 108 ( ...

Subgroup analyses in randomized phase III trials of systemic ...

... subgroup analysis: (i) correction of statistical testing for multiplicity is rarely considered; (ii) test for interaction is applied (or at ...

Outcome based subgroup analysis: a neglected concern - Trials

Treatment strategies for stroke. Bernhardt et al. [21] is a phase II randomized trial of the safety and feasibility of very early mobilization ...

Subgroup Analyses from L-Mind, a Phase II Study of Tafasitamab ...

L-MIND (NCT02399085) is an ongoing, open-label, single-arm, Phase II study of tafasitamab + LEN in patients with R/R DLBCL who are ineligible ...

E 9 Statistical Principles for Clinical Trials Step 5

and hence a subgroup analysis, or a statistical model including interactions, is part of the ... During the planning phase of a trial the principal features of ...

Subgroup analysis of the phase II DELTA study - Lymphoma Hub

The DELTA study found that 150mg idelalisib twice daily showed anti-tumor activity and was tolerated well across four histologic subtypes of ...