ABSTRACT

AE tables are parts of clinical trial report on safetyanalysis. Generally, it is required to present both event numbers and subjectnumbers. To save time and improve the quality of deliverables, we created a SASmacro for company use. In this paper, we explore our macro and show readers howto use simple data step, SQL statements and array functions to get the eventnumbers and subject numbers.

INTRODUCTION

AE tables are important parts of safety analysis in clinicaltrials. Generally speaking, they have relatively similar structures, regardlessof different sponsors or regulatory agencies, which make it feasible andnecessary to compile Macros for creating AE tables. The steps within Macros areactually very simple and straight forward: if number of subjects is required,use SQL distinct USUBJID group by treatment; if both event and subjects numbersare required, calculate them separately and merge together. Why could we notget the subject number and event number at the same time? The reason is thatone subject can have several events. Note: our macros are based on the CDISCdatasets.

Before we describe our macro, let’s see what information weneed in the AE dataset:

Population flags(safety population flag, ITT population flag, etc.)

AE Type(Treatment-emergent AE or Serious AE, etc.)

Treatment information

Coding information(AEBODSYS: System Organ Class, AEDECOD: Dictionary-Derived Term)

Severity (AESEV),Relationship (AEREL)

FREE Download here:

诸位给个评分就好，这才是你对作者最大的鼓励！