Category: SASpphire 蓝宝石

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I have met so many wonderful people along my SAS journey, they are precious like Sapphire to me.

Now I am trying to organize the common SAS functions and procedures I have used on a daily basis, summarize the different CDISC domains that I have worked on and some statistical method I have encountered.

ADPSATA: Prior Systemic Anti-Cancer Therapy Dataset

Background: Systemic Anti-Cancer therapy is a collective to describe the treatment of cancer in conjunction with different categories therapies such as: Surgical Therapies, Radiation Therapy, Stem Cell Transplants, Other Anti-Cancer Therapy.  The ADPSATA: Prior systemic Anti-cancer Therapy dataset presented a key overview of patients’ prior systemic therapy treatments, which may lead to different efficacy endpoint for patients’ current treatments. 

ADSPM: Second Primary Malignancy Dataset

Background Story: One day, I need to validate a SPM related files and ADSPM in a hematology study, I communicated with an experienced colleague many times and finally got the work done. Since each study has different data structure, there is  no standard SPM process  available for all. I will share my experience with SPM work, hopefully it is helpful…

ADLB avisitn

Background Story: In ADLB avisitn means analysis visit number sequence, most of the time it is a standard variable, such that each Visit or Visname maps to a corresponding number. However we had a study with convoluted raw data, in which multiple visits were recorded on the same day or many additional visit.  Today we will go over a basic…

AESI: Adverse Event of Special Interest Mapping

Background Story: One day, I validated an AESI(adverse event of Special Interest) data, I found a discrepancy between two output datasets. After I notified my boss, she suggested checking the AESI excel sheet, and it turns out both versions are partially correct. Because the Prefered term Hepatic Failure belongs to both Hepatic Disorder and Hepatic Failure EOI in a particular…

SAS INTNX Function for Missing Date

Background Story: Missing dates are something the pharmaceutical industry deals with on a daily basis.  There are some common methods. Completely missing year, month, and day then no imputation. Set a certain number( ex.Jan01) for missing month and day Compare with treatment start date, and manipulate accordingly. If the AE start date and the treatment start date have the same…

One Factor Designs

Factorial Design allows the investigation of sets of categorical predictors, and the interaction between them. Today we will go over some basics of One Fixed Factor and One Random Factor Design. Keywords: Factor: categorical predictors Fixed Factors: Estimate the difference in means between groups defined by specified categorical predictors. e.x. ANOVA model, one measurement per subject. Random Factors: Estimate the variance…

Non-inferiority Trial

Background Movie: Based on my taste, 我不是药神 Drug Deal/Dying to Survive is one of the best movies in 2018. It was based on a true story that some cancer patients use a kind of cheap Indian medicine (Veenat 100) as a substitution of the authentic Novartis Glivec 400 to prolong their lives. Besides the touching story, Veenat 100 is a…

Interim Analysis

Background Story: Once, we need to do an Interim Analysis, I didn’t understand why we need to do it. Later I learned in Clinical Trial studies, our ultimate goal is trying to get approval for FDA submission at the end of studies. While exhausting and long progress, sometimes we perform Interim Analysis before the completed trial to access Safety, Futility,…

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