This example shows the administration of a cream with a combination of drugs (X and Y) compared to a cream with a single drug (Y only). Subjects were instructed to apply the cream once daily. Each subject was given an identical 130 g single tube of medication to use between study visits. A new tube was dispensed at each visit and the previously dispensed tube was returned. The returned tubes were weighed and these values were recorded.
The sponsor chose to add EPOCH and to use DASPID to identify each tube dispensed and returned.
Shows that at the first visit on day 1, a tube of study product weighing 130 g was dispensed to the subject.
|Row 2:||Shows that at the second visit on day 15, a tube of study product weighing 10 g was returned by the subject.|
|Rows 3-4:||Show that at visit 2, another 130 g tube was dispensed; this tube was returned at visit 3 weighing 30 g.|
|1||PS014||DA||101||1||1||A311||DISPAMT||Dispensed Amount||Study Product Weight||Tube A||130||g||130||130|
|1||Study Period 1||2012-05-01||1|
|2||PS014||DA||101||2||1||A311||RETAMT||Returned Amount||Study Product Weight||Tube A||10|
|10||10||g||2||Study Period 1||2012-05-15||15|
|3||PS014||DA||101||3||1||A312||DISPAMT||Dispensed Amount||Study Product Weight||Tube A||130||g||130||130|
|2||Study Period 1||2012-05-15||15|
|4||PS014||DA||101||4||1||A312||RETAMT||Returned Amount||Study Product Weight||Tube A||30||g||30||30||g||3||Study Period 1||2012-05-30||30|
The sponsor collected the dates when the subject started and ended using each tube, and the number of missed doses during this interval. The number of missed doses was represented in NSEC.ECNMDOSE and ECDOSE was used to show the number of applications per day.
|Row 1:||Shows the start and end dates for when the tube of medication labeled A311 was used. There was 1 missed dose in the interval.|
|Row 2:||Shows the start and end dates for when the tube of medication labeled A312 was used. There were 2 missed doses in the interval.|
EC NSV Metadata
|ECNMDOSE||Number of Missed Doses||integer||Non-Standard Record Qualifier||CRF|
The sponsor represented the exposure in the EX dataset as 1 record for each tube dispensed. EXDOSE shows the number of applications per day; it was not possible to derive an actual amount of drug used per application or per day. When the subject was randomized to the combination treatment, a record was included for each active component of the combination.
|Rows 1-2:||Show the dosage concentration used for each component of the combination product using EXPSTRG and EXPSTRGU. NSEX.EXNMDOSE indicates the number of missed doses in this interval. EXSPID indicates what tube was used for this dosing interval. EXSPID was used by the sponsor to link to actual weight of the product used in this interval represented in the DA dataset. EXDOSE is provided based on the number of applications.|
Shows the dosage concentration used for the single product.
EX NSV Metadata
|EXNMDOSE||Number of Missed Doses||integer||Non-standard Record Qualifier||CRF|
This is an example of the relationships record between the SDTM domains. --SPID was used to link the relevant datasets.