scholarly journals Subgroup analysis and interpretation for phase 3 confirmatory trials: White paper of the EFSPI/PSI working group on subgroup analysis

2018 ◽  
Vol 18 (2) ◽  
pp. 126-139 ◽  
Author(s):  
Aaron Dane ◽  
Amy Spencer ◽  
Gerd Rosenkranz ◽  
Ilya Lipkovich ◽  
Tom Parke ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Working Group ◽  
White Paper ◽  
Phase 3 ◽  
Confirmatory Trials

scholarly journals Efficacy and safety of teriflunomide in Asian patients with relapsing forms of multiple sclerosis: A subgroup analysis of the phase 3 TOWER study

2019 ◽  
Vol 59 ◽  
pp. 229-231 ◽  
Author(s):  
Aaron E. Miller ◽  
Xianhao Xu ◽  
Richard Macdonell ◽  
Steve Vucic ◽  
Philippe Truffinet ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Subgroup Analysis ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Asian Patients

scholarly journals Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Haematologica ◽  
2021 ◽  
Author(s):  
Marcelo Capra ◽  
Thomas Martin ◽  
Philippe Moreau ◽  
Ross Baker ◽  
Ludek Pour ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Renal Function ◽  
Glomerular Filtration Rate ◽  
Renal Impairment ◽  
Glomerular Filtration ◽  
Subgroup Analysis ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
Phase 3 ◽  
New Therapies

Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The Phase 3 IKEMA study (NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) vs Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate

Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

2010 ◽  
Vol 2 (4) ◽  
pp. 435-454 ◽  
Author(s):  
José Pinheiro ◽  
Frederic Sax ◽  
Zoran Antonijevic ◽  
Björn Bornkamp ◽  
Frank Bretz ◽  
...  
Keyword(s):  
Quantitative Evaluation ◽  
Working Group ◽  
White Paper ◽  
Model Based ◽  
Dose Ranging
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