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
CMTRT
CMDECOD
CMINDC
CMADJ
CMSTRF
CMENRF
This is an example showing how PERT administration data may be represented.
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). |
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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 | CMPRESP | CMOCCUR | CMINDC | CMDOSE | CMDOSU | CMDOSFRM | CMDOSRGM | CMROUTE | CMADJ | CMPSTRG | CMPSTRGU | CMSTDTC | CMENDTC | CMSTRF | CMENRF |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | PACA012 | CM | 1200 | 1 | PANCRELIPASE | Pancrelipase | Pancreatic Enzyme Replacement Therapy | Y | Y | EXOCRINE PANCREATIC INSUFFICIENCY | 2500 | Lipase Units/kg | with meal | ORAL | 2019-05-15 | BEFORE | ||||||
2 | PACA012 | CM | 1200 | 2 | PANCRELIPASE | Pancrelipase | Pancreatic Enzyme Replacement Therapy | Y | Y | EXOCRINE PANCREATIC INSUFFICIENCY | 1000 | Lipase Units/kg | with snack | ORAL | BEFORE | AFTER | ||||||
3 | PACA012 | CM | 1200 | 3 | PANCRELIPASE | Pancrelipase | Pancreatic Enzyme Replacement Therapy | Y | Y | EXOCRINE PANCREATIC INSUFFICIENCY | 3000 | Lipase Units/kg | with meal | ORAL | INSUFFICIENT RESPONSE | 2019-05-15 | AFTER | |||||
4 | PACA012 | CM | 1202 | 1 | PANCRELIPASE | Pancrelipase | Pancreatic Enzyme Replacement Therapy | Y | Y | EXOCRINE PANCREATIC INSUFFICIENCY | 3 | CAPSULE | CAPSULE, DELAYED RELEASE | with meal | ORAL | 25,000 | Lipase Units | BEFORE | AFTER | |||
5 | PACA012 | CM | 1203 | 1 | PANCRELIPASE | Pancrelipase | Pancreatic Enzyme Replacement Therapy | Y | Y | EXOCRINE PANCREATIC INSUFFICIENCY | 30000 | Lipase Units | with meal | ORAL | 2020-07-01 | AFTER |