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The infant nutrition product as described in the following example is a blinded infant formula powder for term infants provided in cans. It is very common for young infants to spit up some of the formula and the occurrence of spitting up was recorded. This is sometimes limited to a certain period after the feeding. In most studies, the daily intake NUT-102 - Getting issue details... STATUS is recorded by the caregivers in a diary.

Example

In this example, only the total volume of blinded infant formula administered at each feed was collected. The Exposure as Collected (EC) domain is used to represent data on exposure as collected (e.g., in a blinded fashion). Occurrences of "spitting up" or "vomiting" within 1 hour of feeding were also collected. Note that because this information is collected on a daily diary, line numbers start at 1 for each diary day. Because this variable alone cannot be used to link the Exposure as Collected (EC) and Clinical Events (CE) dataset, ECLNKID and CELNKID is formed from the line number and day number from the diary which, when combined, is a unique identifier and is used in the RELREC linking relationship.

 ec.xpt
Row 1:Shows the volume of blinded study Formula A consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the volume of blinded study Formula B consumed by the infant on the second feed of the diary (Day 1).

ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECLNKID

ECTRT

ECDOSE

ECDOSU

ECDOSFRM

ECROUTE

ECSTDTC

ECENDTC

ECSTDY

ECENDY

1ABCEC1011D1-1Feeding Formula A50mLSUSPENSIONORAL2017-05-19T13:002017-05-19T13:0011
2ABCEC1012D1-2Feeding Formula B60mLSUSPENSIONORAL2017-05-19T19:002017-05-19T19:0011

"Spit-up" and "Vomit" information is represented in the CE domain.

 ce.xpt
Rows 1, 2:Show the response to the "spitting up" and "vomiting" questions on the first feed of the diary (Day 1).
Rows 3, 4:Show the response to the "spitting up" and "vomiting" questions on the second feed of the diary (Day 1).

ce.xpt

Row

STUDYID

DOMAIN

USUBJID

CESEQ

CEGRPID

CELNKID

CETERM

CEPRESP

CEOCCUR

CEDTC

CEDY

CEEVINTX

1ABCCE10111D1-1VomitingYN2017-05-191Within 1 hour after feeding
2ABCCE10121D1-1Spitting upYY2017-05-191Within 1 hour after feeding
3ABCCE10132D1-2Vomiting
YN2017-05-191Within 1 hour after feeding
4ABCCE10142D1-2Spitting up
YY2017-05-191Within 1 hour after feeding

Once the study was unblinded, the EC data could be represented in the EX domain, with ECLNKID and EXLNKID again acting as a unique identifier used in the RELREC linking relationship. Note that if this was an unblinded study, then the data may have been represented directly in EX without the need to use the EC domain. Please refer to Section 6.1 of SDTMIG v3.3, which describes the use of the EC and EX domains and the requirements to document derivations used to show data in EX in the define.xml file.

 ex.xpt
Row 1:Shows the volume of study formula consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the volume of study formula consumed by the infant on the second feed of the diary (Day 1).

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXLNKID

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXSTDY

EXENDY

1ABCEX1011D1-1Nutra50mLSUSPENSIONORAL2017-05-19T13:002017-05-19T13:0011
2ABCEX1012D1-2Nutra-Plus60mLSUSPENSIONORAL2017-05-19T19:002017-05-19T19:0011

The relrec.xpt example is represented below.

 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1ABCEC
EXLNKID
ONE1
2ABCEX
ECLNKID
ONE1
2ABCCE
CELNKID
MANY1

The infant nutrition product as described in the following example is a blinded infant formula powder for term infants provided in cans. To prepare the formula, the formula powder was measured as spoons and mixed with a specified amount of water. The volume of prepared formula was collected and then fed to the infant (i.e., subject in the study) and any leftover volume was again measured.

Example

In this blinded study, the sponsor gave the infant caregiver a tin of formula and a daily diary to complete. The caregiver made up a bottle of formula using a set number of spoons of formula with water. The volume of formula prepared and volume of formula left after feeding was recorded. For the purposes of this example only the first 3 feeds are recorded.

The volume prepared and the volume remaining after feeding is represented in the DA (Product Accountability) domain. Please see Section 1.4, Known Issues, for information on a proposal to extend the use of the DA domain to include cover "product" accountability.

 da.xpt
Rows 1-2:Show the volume of formula prepared and the volume of formula left after feeding for the first feed of the diary (Day 1).
Rows 3-4:Show the volume of formula prepared and the volume of formula left after feeding for the second feed of the diary (Day 1).
Rows 5-6:Show the volume of formula prepared and the volume of formula left after feeding for the third feed of the diary (Day 2).

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAGRPIDDASPIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDDADTCDADY
 1 ABCDA101111PREPAMTPrepared AmountStudy Product
 100mL100100mL

2017-05-19  1
 2 ABCDA101211REMAMTRemaining AmountStudy Product
 15mL1515mL

 2017-05-19 1
3ABCDA101322PREPAMTPrepared AmountStudy Product
100mL100100mL

2017-05-19 1
4ABCDA101422REMAMTRemaining AmountStudy Product
25mL2525mL

 2017-05-19 1
5ABCDA101531PREPAMT
Prepared AmountStudy Product
100mL100100mL

 2017-05-202
6ABCDA101631REMAMTRemaining AmountStudy Product
10mL1010mL

 2017-05-202

The actual amount of unblinded study product exposed to the infant is represented in the EX domain. The sponsor chose to represent this as a weight (g) of study product actually consumed by the infant. This was calculated using the actual amount of feed consumed by the infant (total volume prepared minus total volume remaining) NUT-133 - Getting issue details... STATUS , and then converting the total number of spoons used to make up the product to the actual number of spoons consumed. Note that in this study each spoon used was 15 g of study product and 2 spoons of formula was always used to prepare the feed. It is generally accepted that this type of derived exposure information can be represented in SDTM in the EX domain. Please refer to Section 6.1 of SDTMIG v3.3, which describes the use of EC and EX domains and the requirements to document the derivations used to show data in EX in the define.xml file.

 ex.xpt
Row 1:Shows the weight of study formula consumed by the infant on the first feed of the diary (Day 1).
Row 2:Shows the weight of study formula consumed by the infant on the second feed of the diary (Day 1).
Row 3:Shows the weight of study formula consumed by the infant on the third feed of the diary (Day 2).

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXLNKID

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXSTDY

EXENDY

1ABCEX10111Nutra25.5gPOWDER, FOR SOLUTIONORAL2017-05-192017-05-1911
2ABCEX10122Nutra22.5gPOWDER, FOR SOLUTIONORAL2017-05-192017-05-1911
3ABCEX10133Nutra

27

gPOWDER, FOR SOLUTIONORAL2017-05-202017-05-2022

The relrec.xpt example is represented below.

 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1ABCDA
DAGRPID
MANY1
2ABCEX
EXLNKID
ONE1

In some clinical studies, breastfeeding may be used as a comparator to study products and therefore may need to be represented as "exposure" information. This data may be collected in a variety of formats (e.g., start and stop times of individual feeds, duration of each breast feeding episode/number of minutes on the breast, total breast feeding time for a day). Breastfeeding may also be collected as “background” data, in which case it would be represented in the draft Meal Data (ML) domain NUT-101 - Getting issue details... STATUS . If represented in ML, the data structure would look the same as the Exposure (EX) examples apart from with the ML domain code/variables.

Example

This example shows representing breastfeeding in EX with individual start and stop times per feed.

 ex.xpt
Row 1:Shows an example of breast-fed milk. Note that there is no EXDOSE because the actual amount of milk fed can not be determined when feeding is direct from the breast.
Row 2:Shows an example of expressed breast milk that is fed using a bottle. The amount of milk consumed is represented in EXDOSE, as this was collected based on the volume fed from the bottle.

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

1ABCEX1011Breast Milk


ORAL2017-05-19T13:002017-05-19T13:20
2ABCEX1012Breast Milk50mL
ORAL2017-05-19T17:002017-05-19T17:15

Example

This example shows representing breastfeeding as a duration in minutes per feed. Note that the SDTM variable EXDUR variable can only be used if this data is collected on the CRF and cannot be derived from start and stop times. If duration needs to be calculated from start and stop times, this should be done in an ADaM dataset.

 ex.xpt

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC

EXDUR
1ABCEX1011Breast Milk


ORAL2017-05-192017-05-19PT20M
2ABCEX1012Breast Milk


ORAL2017-05-192017-05-19PT15M

Example

This example shows representing breastfeeding as a total number of feeds per day.

 ex.xpt

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXSTDTC

EXENDTC


EXNADEVI
1ABCEX1011Breast Milk


ORAL2017-05-192017-05-19
4

EX NSV Metadata

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