Calculated Dose

Illustrates Domains

Illustrates Variables

EXTRT
EXDOSTOT
EPOCH

Content

In this example, the subjects applied a cream with a treatment concentration of 1% (10 mg/g) or 2% (20 mg/g) once daily to a target lesion for 5 days. The cream was supplied in 1-gram, single-dose tubes and the weight of each returned tube was determined. The sponsor used the concentration of drug in each tube and the returned weight of each tube to derive the actual total daily dose. Sponsors may elect to use an ADaM dataset to represent this information if missing data imputation is used to determine the total dose.

The EC domain may be used to represent data on the subject's daily applications and the DA domain used to represent the returned weight of each tube, as shown in other examples in this section. The following example only shows the days when the drug was applied.

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Row 1:	Shows that subject 101 administered drug X on the first study day only.
Rows 2-5:	Show that subject 102 administered drug Y for 5 days starting on study day 2.

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Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSTOT	EXDOSU	EXDOSFRM	EXDOSFRQ	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY
1	PS013	EX	101	1	Drug X	10	mg	CREAM	QD	TREATMENT	2012-05-01	2012-05-01	1	1
2	PS013	EX	102	1	Drug Y	8	mg	CREAM	QD	TREATMENT	2012-05-02	2012-05-02	2	2
3	PS013	EX	102	2	Drug Y	10	mg	CREAM	QD	TREATMENT	2012-05-03	2012-05-03	3	3
4	PS013	EX	102	3	Drug Y	6	mg	CREAM	QD	TREATMENT	2012-05-04	2012-05-04	4	4
5	PS013	EX	102	4	Drug Y	8	mg	CREAM	QD	TREATMENT	2012-05-05	2012-05-05	5	5
6	PS013	EX	102	5	Drug Y	8	mg	CREAM	QD	TREATMENT	2012-05-06	2012-05-06	6	6