Pancreatic Enzyme Replacement Therapy

Illustrates Domains

CM

Illustrates Variables

CMTRT
CMDECOD
CMINDC
CMADJ
 CMSTRF
 CMENRF


Content

This is an example showing how PERT administration data may be represented.

cm.xpt
Row 1:Shows that subject 1200 took 2500 lipase units/kg of pancrelipase with a meal. This treatment started before the sponsor-defined study reference period and ended (as shown in CMENDTC).
Row 2:

Shows the subject took 1000 lipase units/kg of pancrelipase with a snack. This treatment started before and ended after the sponsor-defined study reference period.

Row 3:Shows the dose was increased to 3000 lipase units/kg of pancrelipase with a meal. This new dose was started as shown in CMSTDTC.
Row 4:

Shows data for subject 1202 using the number of capsules, rather than dosage. The strength of each capsule is represented in CMPSTRG and CMPSTRGU.

Row 5:Shows that subject 1203 took a total of 30,000 lipase units per meal. The treatment ended after the study.

cm.xpt

Row

STUDYID

DOMAIN

USUBJID

CMSEQ

CMTRT

CMDECOD

CMCAT

CMPRESPCMOCCURCMINDC

CMDOSE

CMDOSU

CMDOSFRM

CMDOSRGM

CMROUTE

CMADJCMPSTRGCMPSTRGU

CMSTDTC

CMENDTC

CMSTRF

CMENRF

1PACA012CM12001PANCRELIPASEPancrelipasePancreatic Enzyme Replacement TherapyYYEXOCRINE PANCREATIC INSUFFICIENCY2500

Lipase Units/kg



with mealORAL





2019-05-15BEFORE
2PACA012CM12002PANCRELIPASEPancrelipasePancreatic Enzyme Replacement TherapyYYEXOCRINE PANCREATIC INSUFFICIENCY1000

Lipase Units/kg



with snackORAL




BEFOREAFTER
3PACA012CM12003PANCRELIPASEPancrelipasePancreatic Enzyme Replacement TherapyYYEXOCRINE PANCREATIC INSUFFICIENCY3000

Lipase Units/kg


with mealORALINSUFFICIENT RESPONSE

2019-05-15

AFTER
4PACA012CM12021PANCRELIPASEPancrelipasePancreatic Enzyme Replacement TherapyYYEXOCRINE PANCREATIC INSUFFICIENCY3CAPSULECAPSULE, DELAYED RELEASEwith mealORAL
25,000

Lipase Units



BEFOREAFTER
5PACA012CM12031PANCRELIPASEPancrelipasePancreatic Enzyme Replacement TherapyYYEXOCRINE PANCREATIC INSUFFICIENCY30000Lipase Units
with mealORAL


2020-07-01

AFTER