8  HEM 24599_Elritercept

8.1 Study Numbers

# Load required library for creating tables
library(knitr)

# Create a data frame with the sample size determination details
sample_size_table <- data.frame(
  Parameter = c(
    "Total Sample Size",
    "Elritercept Group Size",
    "Placebo Group Size",
    "Elritercept Response Rate",
    "Placebo Response Rate",
    "Difference in Response Rates",
    "Power",
    "Alpha Level",
    "Test Type",
    "Variance Estimate",
    "HTB Enrollment Cap",
    "Non-RS LR-MDS Enrollment Cap"
  ),
  Value = c(
    "225 participants",
    "150 participants",
    "75 participants",
    "40%",
    "15%",
    "25%",
    "≥90%",
    "0.05 (2-sided)",
    "Difference of Proportions",
    "Pooled Estimate",
    "~60% of total",
    "~25% of total"
  )
)

# Display the table using kable for a clean format
kable(sample_size_table, caption = "Sample Size Determination Summary")

Sample Size Determination Summary

Parameter	Value
Total Sample Size	225 participants
Elritercept Group Size	150 participants
Placebo Group Size	75 participants
Elritercept Response Rate	40%
Placebo Response Rate	15%
Difference in Response Rates	25%
Power	≥90%
Alpha Level	0.05 (2-sided)
Test Type	Difference of Proportions
Variance Estimate	Pooled Estimate
HTB Enrollment Cap	~60% of total
Non-RS LR-MDS Enrollment Cap	~25% of total