Patient diaries can be used to collect information on number of stools and consistency on a daily basis. In this case, the calculation of average number of stools or the typical consistency over the 3-day period may be calculated in an ADaM dataset from this source data.
This example shows baseline stool information for actual daily number of bowel movements and typical stool consistency each day over a 3-day period prior to the baseline visit. Please note that it may be important for sponsors to provide additional instructions to the diary (e.g., how a subject should evaluate their consistency if they had 1 loose and 1 hard stool in a day).
The sponsor chose to use a paper diary that was given to subject prior to the visit and then handed back at the visit where this was entered into the EDC system.
The total daily number of bowel movements for each of the 3 days of the diary is represented in the FACE dataset
NUT-125Getting issue details...
. The daily total number of bowel movements was assessed by the subject therefore FAEVAL was used to represent this.
NUT-136Getting issue details...
|BOWEL MOVEMENT||2||/day||2||2||/day||SUBJECT||2017-01-02||END OF DIARY DAY -3||-3||-P1D|
|2||NUTR123||FA||NUTR123_001||2||D-2_1||2||EVENTFRQ||Event Frequency||BOWEL MOVEMENT||3||/day||3||3||/day||SUBJECT||2017-01-03||END OF DIARY DAY -2||-2||-P1D|
|3||NUTR123||FA||NUTR123_001||3||D-1_1||3||EVENTFRQ||Event Frequency||BOWEL MOVEMENT||2||/day||2||2||/day||SUBJECT||2017-01-04||END OF DIARY DAY -1||-1||-P1D|
|1||NUTR123||LB||NUTR123_001||1||D-3_1||1||CONSIST||Consistency||Loose||Loose||STOOL||SUBJECT||2017-01-02||END OF DIARY DAY -3||-3||-P1D||TYPICAL|
|2||NUTR123||LB||NUTR123_001||2||D-2_1||2||CONSIST||Consistency||Hard||Hard||STOOL||SUBJECT||2017-01-03||END OF DIARY DAY -3||-2||-P1D||TYPICAL|
|3||NUTR123||LB||NUTR123_001||3||D-1_1||3||CONSIST||Consistency||Loose||Loose||STOOL||SUBJECT||2017-01-04||END OF DIARY DAY -3||-1||-P1D||TYPICAL|
LB NSV Metadata
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When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.