![TEMPLATE DESIGN 息 2008
www.PosterPresentations.com
Mucositis
A Randomized Double-Blind Placebo-Controlled Phase III Multicenter
Trial
Background
..
Eligibility Criteria
Subjects Adherence
.
Alfonso Arellano Reyonso, Alvaro Mitsunori Nishikawa, Camila Pontes, Carolin Zimmermann, Claudia Pavarelli, Daniel Boner, Edson Batista, Eliana C M Miranda, Geovanna Cardenas,
Gonzalo Romero, Jose Cardoso, Julio Cesar Marin Concha, Laura Violeta Ochoa Bernal, Lucas Amaral, Luciano Miller Reis Rodrigues, Marcos Rivas, Marcos Antonio Almeida Santos,
Michael Pizarro, Moshrik Abd alamir, Nancy Torres, Patricia Maida, Rodrigo Modolo, Roman Rodionov, Salwa Alaidarous, Sergio C叩ceres Castaldi, Thaiana Santana, Thulio Cunha
TAs: G4 - Camila Cosmo, Jairo Alberto Dussan, Margarita Garcia, Raquel Ajub Moyses, Hernan Sacoto
A double-blind approach will be implemented,
mainly because the dependent variable
represents a soft outcome., furthermore, it can
be influenced by subjective aspects, posing a
potential risk of observation bias .
So, all involved in the research will not be informed of which
treatment has been chosen for each arm and individual until
the end of the study. The blinding process will be assessed
and graded according to the James scale [11]. Both types of
pills will have the same shape, size, color and taste. One
interim analysis will be applied for safety and efficacy, when
50% of the sample will reach, depending on partial results
from the group sequential approach, unblinding may occur
and the study put to a halt.
Blinding
Subjects Recruitment Outcome Measures (endpoints)
Randomization and intervention
Sample Size Calculation
Statistical Analysis
References
Pitfalls](https://image.slidesharecdn.com/poster-group4-ppcr-130926121817-phpapp01/85/Poster-group-4-ppcr-1-320.jpg)
Poster group 4 - ppcr
- 1. TEMPLATE DESIGN 息 2008 www.PosterPresentations.com Mucositis A Randomized Double-Blind Placebo-Controlled Phase III Multicenter Trial Background .. Eligibility Criteria Subjects Adherence . Alfonso Arellano Reyonso, Alvaro Mitsunori Nishikawa, Camila Pontes, Carolin Zimmermann, Claudia Pavarelli, Daniel Boner, Edson Batista, Eliana C M Miranda, Geovanna Cardenas, Gonzalo Romero, Jose Cardoso, Julio Cesar Marin Concha, Laura Violeta Ochoa Bernal, Lucas Amaral, Luciano Miller Reis Rodrigues, Marcos Rivas, Marcos Antonio Almeida Santos, Michael Pizarro, Moshrik Abd alamir, Nancy Torres, Patricia Maida, Rodrigo Modolo, Roman Rodionov, Salwa Alaidarous, Sergio C叩ceres Castaldi, Thaiana Santana, Thulio Cunha TAs: G4 - Camila Cosmo, Jairo Alberto Dussan, Margarita Garcia, Raquel Ajub Moyses, Hernan Sacoto A double-blind approach will be implemented, mainly because the dependent variable represents a soft outcome., furthermore, it can be influenced by subjective aspects, posing a potential risk of observation bias . So, all involved in the research will not be informed of which treatment has been chosen for each arm and individual until the end of the study. The blinding process will be assessed and graded according to the James scale [11]. Both types of pills will have the same shape, size, color and taste. One interim analysis will be applied for safety and efficacy, when 50% of the sample will reach, depending on partial results from the group sequential approach, unblinding may occur and the study put to a halt. Blinding Subjects Recruitment Outcome Measures (endpoints) Randomization and intervention Sample Size Calculation Statistical Analysis References Pitfalls