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This is an example of an ADCM dataset and is based primarily on input from the SDTM EX dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
Below is is an example of the input SDTM EX dataset used to create the ADEX. Only variables needed for illustration are shown in the examples.
ex.xpt
ex.xpt
ex.xpt
Row STUDYID DOMAIN USUBJID EXSEQ SPTOBID EXREFID EXTRT EXDOSE EXDOSU EXDOSFRM EXROUTE EXPSTRG EXPSTRGU EXSTDTC EXENDTC 1 A123 EX A2001 1 VAPE-Z27 CRT8754 e-nicotine liquid 6 mL CARTRIDGE RESPIRATORY (INHALATION) 8 mg/mL 2021-01-08 2020-01-14 2 A123 EX A2001 2 VAPE-Z27 CRT8768 e-nicotine liquid 6.4 mL CARTRIDGE RESPIRATORY (INHALATION) 8 mg/mL 2021-01-15 2020-01-21 3 A123 EX A2001 3 VAPE-Z27 CRT9756 e-nicotine liquid 7 mL CARTRIDGE RESPIRATORY (INHALATION) 8 mg/mL 2021-01-22 2020-01-28 4 A123 EX A2008 1 VAPE-Z27 CRT8000 e-nicotine liquid 5 mL CARTRIDGE RESPIRATORY (INHALATION) 0 mg/mL 20221-02-08 2021-02-14 5 A123 EX A2008 2 VAPE-Z27 CRT9006 e-nicotine liquid 7 mL CARTRIDGE RESPIRATORY (INHALATION) 0 mg/mL 20221-02-15 2021-02-21 6 A123 EX A2008 3 VAPE-Z27 CRT9008 e-nicotine liquid 8 mL CARTRIDGE RESPIRATORY (INHALATION) 0 mg/mL 20221-02-22 2021-03-01 7 A123 EX A3009 1 VAPE-Z27 CRT9128 e-nicotine liquid 8 mL CARTRIDGE RESPIRATORY (INHALATION) 4 mg/mL 2021-06-09 2021-06-15 8 A123 EX A3009 2 VAPE-Z27 CRT6868 e-nicotine liquid 6.7 mL CARTRIDGE RESPIRATORY (INHALATION) 4 mg/mL 2021-06-16 2020-10-15 9 TENDS01 EX A3009 3 VAPE-Z27 CRT7868 e-nicotine liquid 5.5 mL CARTRIDGE RESPIRATORY (INHALATION) 4 mg/mL 2020-10-15 2020-10-22