5  ABNL-MARRO Arm B

5.1 Statistical Analysis Plan

  • This is the study showed Rux plus AZA has a response rate of 54%(Arora et al. 2023) in MDS/MPN overlap syndromes

  • The above study is a 5-year follow-up study

library (knitr)

Simon’s Two-Stage Optimal Design for RUX+AZA Trial
Parameter Value
Null hypothesis (H₀) Response rate = 0.54
Alternative hypothesis (H₁) Response rate = 0.69
Type I error (α) 0.10
Power (1-β) ≥ 0.80
Stage 1 patients 22
Stage 1 continue threshold > 12 responses
Stage 2 additional patients 32
Total patients 54
Reject H₀ threshold ≥ 34 responses
Early stopping If ≤ 12 responses in stage 1

5.2 Powerpoint Presentation Slides


Attaching package: 'dplyr'
The following objects are masked from 'package:stats':

    filter, lag
The following objects are masked from 'package:base':

    intersect, setdiff, setequal, union

Attaching package: 'gridExtra'
The following object is masked from 'package:dplyr':

    combine
Warning: Using `size` aesthetic for lines was deprecated in ggplot2 3.4.0.
ℹ Please use `linewidth` instead.
Warning in annotate("text", x = 2.75, y = 6.5, label = "3+3 Dose
De-Escalation", : Ignoring unknown parameters: `style`
Warning in annotate("text", x = 7.75, y = 6.5, label = "Treatment-naïve only",
: Ignoring unknown parameters: `style`
Warning in annotate("text", x = 12.75, y = 6.5, label = "Treatment-naïve or
Previously treated", : Ignoring unknown parameters: `style`
Warning in annotate("text", x = 2.75, y = 3.5, label = "Dose optimization", :
Ignoring unknown parameters: `style`
Warning in annotate("text", x = 7.75, y = 3.5, label = "Treatment-naïve only",
: Ignoring unknown parameters: `style`
Warning in annotate("text", x = 12.75, y = 3.5, label = "Treatment-naïve or
Previously treated", : Ignoring unknown parameters: `style`
PowerPoint presentation saved as: Clinical_Study_Schematic.pptx 
The presentation includes:
- Title slide
- Study overview
- Main schematic diagram
- Treatment arms detail
- Phase design & objectives
- Key definitions
- Study timeline
pptx document with 7 slides
Available layouts and their associated master(s):
             layout       master
1       Title Slide Office Theme
2 Title and Content Office Theme
3    Section Header Office Theme
4       Two Content Office Theme
5        Comparison Office Theme
6        Title Only Office Theme
7             Blank Office Theme
Warning in annotate("text", x = 2.75, y = 6.5, label = "3+3 Dose
De-Escalation", : Ignoring unknown parameters: `style`
Warning in annotate("text", x = 7.75, y = 6.5, label = "Treatment-naïve only",
: Ignoring unknown parameters: `style`
Warning in annotate("text", x = 12.75, y = 6.5, label = "Treatment-naïve or
Previously treated", : Ignoring unknown parameters: `style`
Warning in annotate("text", x = 2.75, y = 3.5, label = "Dose optimization", :
Ignoring unknown parameters: `style`
Warning in annotate("text", x = 7.75, y = 3.5, label = "Treatment-naïve only",
: Ignoring unknown parameters: `style`
Warning in annotate("text", x = 12.75, y = 3.5, label = "Treatment-naïve or
Previously treated", : Ignoring unknown parameters: `style`
Custom PowerPoint presentation saved as: Custom_Study_Schematic.pptx 
pptx document with 2 slides
Available layouts and their associated master(s):
             layout       master
1       Title Slide Office Theme
2 Title and Content Office Theme
3    Section Header Office Theme
4       Two Content Office Theme
5        Comparison Office Theme
6        Title Only Office Theme
7             Blank Office Theme