Tolerance Test 3

Illustrates Domains

AG

Illustrates Variables

AGPRESP
AGOCCUR
AGENDTC
AGREASOC (NSV)


Content

This is an example of a study where the end time of the meal was collected. If the meal was not administered, the reason for not administering the meal was collected. This example shows data for two subjects where a standard meal is administered. The date and time of meal administration, the percentage of meal consumed, and the end time of meal administration were collected. This test requires that the subject be in a fasting state.  In this example, one subject was not fasting at a follow-up visit, so the test was not done. A non-standard variable is used to represent that the reason the meal tolerance test was not done was due to not being in a fasted state.

ag.xpt
Row 1:Subject "XYZ-001-001" was given a standard meal 2 hours prior to study drug administration at baseline.
Row 2:Subject "XYZ-001-001" was given a standard meal 30 minutes after study drug administration after 26 weeks.
Row 3:Subject "XYZ-001-002" was given a standard meal 2 hours prior to study drug administration at baseline.
Row 4:The meal was not administered at 26 weeks because the subject was not fasting as required for this test.

ag.xpt

RowSTUDYIDDOMAINUSUBJIDAGSEQAGTRTAGCATAGPRESPAGOCCURAGDOSTXTVISITAGDTCAGSTDTCAGENDTCAGTPTREFAGRFTDTCAGTPTNUMAGTPTAGELTM

AGREASOC
1XYZAGXYZ-001-0011STANDARD MEALMIXED MEAL TOLERANCE TESTYY100 %BASELINE DAY 12010-05-032010-05-03T08:002010-05-03T08:10STUDY DRUG ADMINISTRATION2010-05-03T10:00-120PRE-DOSE-PT120M



2XYZAGXYZ-001-0012STANDARD MEALMIXED MEAL TOLERANCE TESTYY100 %WEEK 262010-11-012010-11-01T08:302010-11-01T08:35STUDY DRUG ADMINISTRATION2010-11-01T08:003030 MIN POST-DOSEPT30M



3XYZAGXYZ-001-0021STANDARD MEALMIXED MEAL TOLERANCE TESTYY100 %BASELINE DAY 12010-06-032010-06-03T09:002010-06-03T09:10STUDY DRUG ADMINISTRATION2010-06-03T11:00-120PRE-DOSE-PT120M



4XYZAGXYZ-001-0022STANDARD MEALMIXED MEAL TOLERANCE TESTYN

WEEK 262010-12-01



STUDY DRUG ADMINISTRATION

3030 MIN POST-DOSEPT30M

Subject was not fasting

AG NSV Metadata