In sequential and cross-over trials, the sequence and period are reported. In parallel trials, these data are usually skipped. In multi-part trials, the part is displayed either in the title, headline or column. A footnote indicates how BQL values are reported. SPONSOR/PROTOCOL/PRODUCT INFO (page x of x) Listing 16.2.5-x.x Pharmacokinetic concentration by compound, matrix, analyte and [actual/randomised] [treatments/group] Analysis Set : PK analysis set Compound: XXX, Matrix: YYY, Analyte: ZZZ [Actual/Randomised] [treatment/group] [sequence]: AAAAAA Scheduled Country/ Age/ Elapsed Profile Sampling Date/Time of Concentration Site/ Sex/ Period Time day Time collection (uom) Subject Race (uom) (uom) CNTR/ YY/ 1 1 0.5 2000-02-12Txx:xx xx.x xxx.xx * ST1/ M/ XXXXX Ca 1.0 2000-02-12Txx:xx xx.x xxx.xx 1.5 2000-02-12Txx:xx xx.x xxx.xx - Value * was not considered for summary and inferential procedures. - Values <LLOQ were considered as [zero;missing;LLOQ; LLOQ/Z;…]. - Age/Sex/Race: M=Male, F=Female, Ca=Caucasian, … PATH DATA/PROGRAM/OUTPUT PRODUCTION STATUS/RUN DMMMYYYY: HHMM Figure 82. Shell for individual PK concentration listing Annotations: If the actual treatment is known and if it differs from the randomised treatment, it is recommended to report according to actual treatment. Otherwise, the randomised treatment is reported.
In sequential and cross-over trials, the sequence and period are reported. In parallel trials, these data are usually skipped. In multi-part trials, the part is displayed either in the title, headline or column. A footnote indicates how BQL values are reported. SPONSOR/PROTOCOL/PRODUCT INFO (page x of x) Listing 16.2.5-x.x Pharmacokinetic concentration by compound, matrix, analyte and [actual/randomised] [treatments/group] Analysis Set : PK analysis set Compound: XXX, Matrix: YYY, Analyte: ZZZ [Actual/Randomised] [treatment/group] [sequence]: AAAAAA Country/ Site/ Subject Age/ Sex/ Race Period Profile day Scheduled Sampling Time (uom) Date/Time of collection Elapsed Time (uom) Concentration (uom) CNTR/ ST1/ XXXXX YY/ M/ Ca 1 1 0.5 2000-02-12Txx:xx xx.x xxx.xx * 1.0 2000-02-12Txx:xx xx.x xxx.xx 1.5 2000-02-12Txx:xx xx.x xxx.xx - Value * was not considered for summary and inferential procedures. - Values <LLOQ were considered as [zero;missing;LLOQ; LLOQ/Z;…]. - Age/Sex/Race: M=Male, F=Female, Ca=Caucasian, … PATH DATA/PROGRAM/OUTPUT PRODUCTION STATUS/RUN DMMMYYYY: HHMM Figure 82. Shell for individual PK concentration listing Annotations: If the actual treatment is known and if it differs from the randomised treatment, it is recommended to report according to actual treatment. Otherwise, the randomised treatment is reported.