Background Story: Once my boss asked me to review an Open CDISC report for SDTM dataset packages. I wasn’t sure what to do at first. With the help of my colleagues, I gradually develop a sense of how to review the CDISC report. I’d like to share some review processes and common Open CDISC Summary from PINNACLE21.

# Category: SASpphire 蓝宝石

## Unix Command

Today I want to share some basic Unix commands I use recently in Putty. Directory: Direct the path to a certain location cd /… cd – {home directory} pwd {show current working directory} Files: List current files ls {path} ls -l {date,size, permission} Check/Change Access: Read is 4. Write is 2. Execute is 1. ls -lah xyz(u,group,everyone else)…

## Variable Types in Statistics

In data science, we usually classify variables into two big types: Continuous(age), Categorical(sex). What about the variables in clinical trials/statistics? How many different types do we have? Little goal: Today we will learn the six common types of variable in statistics? How to use and present them in clinical trials?

## SAS ANYALPHA Function

SAS day 56: ANYALPHA Background Story: Once we had an excel sheet with an extreme variety of date formats that don’t make sense. Is there a method to clean the data so they will be meaningful dates? Raw Data: Solutions Ideas: After observing the data structure, we notice it either starts with a letter or number. Therefore, we will apply…

## Proc Export +Proc Report to Fancy Excel Output

SAS day 55 Background Story: Once we need to generate an Adverse Event listing for the medical team to review in excel, I was amazed by my colleague’s colorful output from SAS. I was just simply happy to look at the output! Example: I will use SAS.cars to generate the output SAS Code: *—————————–*; * To generate excel…

## SAS Proc Format

SAS day 54 We know Format is a common function to convert date in SAS, such as, format aestdt date9. . What about Proc Format? When and how should we use it? Case 1: Numeric to Character Presentation When data are coded in numerical, we would like to display it in characters in Frequency tables. Syntax: Proc Format;…

## Confidence Interval for Adverse Event

sas day 53: A classical AE table is by SOC (body system class) and Preferred term( AEDECOD). The overall AE table could last for over 100 pages long. What if we’d like to see the count and confidence Interval for some Special Interested Adverse Event (SIAE) within the whole safety population. Challenge: How to generate an AE table with confidence…

## One-tailed vs Two-tailed Test for P value

R day 3 In clinical trial studies, P-value is critical for measuring drug efficacy. Typically, the statistical analysis Plan will describe statistical significance as: P-value <0.05 for two-tailed Log Rank Test. Recently, I came across a study with the statistical significance as P-value <0.025 for one-tailed Log Rank test in the analysis plan. Question: Does two-tailed P-value= 0.05 means the…

## SAS rename

SAS Day 52 Once I use SAS proc import a Special Adverse Event dataset, everything looks good, except the variable name was directly from excel and has space and special characters like “/” (EOI/ Search) Little Challenge: How to Rename a variable with space or special characters? Basic Rename Syntax: *1. within dataset data a; set a; rename old_name=new_name; run;…

## Restricted Mean Survival Analysis

Inspired by Joe Wang and Tony Qi, i did a summarization of Survival analysis and Restricted Mean Survival Analysis.

Restricted Mean Survival Analysis