The infusion was administered at a local infusion center. Before each infusion, the participant's BSA was determined.
This Vital Signs (VS) dataset shows the representation of BSA recorded by the investigator. VSLNKID is used to link the BSA to each performed (actual) infusion.
|Row 1:||Shows the subject's BSA at the screening visit, recorded by the investigator using a nomogram based on the Du Bois and Du Bois formula.|
Show the subject's BSA on the day of study drug administration, recorded by the infusion center using the same nomogram. Because the sponsor did not assign visit number to the infusion data, VISITNUM and VISIT are blank but are included because they are expected variables.
|1||PACA014||VS||1400||1||BSA||Body Surface Area||1.84||m2||1.84||m2||Du Bois and Du Bois (1916)||Y||1||SCREENING||2020-07-14|
|2||PACA014||VS||1400||2||20200714T10:20||BSA||Body Surface Area||1.81||m2||1.81||m2||Du Bois and Du Bois (1916)||2020-08-28|
|3||PACA014||VS||1400||3||20200828T08:00||BSA||Body Surface Area||1.79||m2||1.79||m2||Du Bois and Du Bois (1916)||2020-08-28|
The following example Exposure as Collected (EC) and Exposure (EX) datasets were created by the sponsor using the information collected on the Study Drug Administration CRF.
The EC domain is used to represent the exposure data as collected. As the treatment was blinded to the subject and investigator, ECTRT was assigned the value of "TREATMENT". The sponsor limited access to this data during the trial to ensure treatment blinding.
The infusion log, used by the infusion center, included the prescribed dose and the total amount of drug administered. The prescribed dose was represented using ECMOOD = "SCHEDULED". This scheduled record was also used to represent the planned infusion duration (using the NSV ECPLDUSA) and the intended dose frequency. Records with ECMOOD = "PERFORMED" were based on the actual exposure information. The sponsor decided to represent the adjustment reasons for dose, dose delay and infusion duration on both the "PERFORMED" and "SCHEDULED" records.
ECLNKGRP links the scheduled and performed dosing records for each dose in EC and to the EX domain. ECLNKGRP was assigned the dose number; another option would be to default ECLNKGRP to the data management record number for each dose. The sponsor recorded the reason the treatment was permanently discontinued on a separate End of Treatment Disposition CRF (not shown).
Shows that the subject was to receive the assigned treatment every 2 weeks using a planned 90-minute infusion (NSEC.ECPLDUSA) at a dose of 80mg/m2. The infusion was prescribed to be started on the date given in ECSTDTC.
Shows the actual dose given in mg. ECSTDTC and ECENDTC provide the actual start and end dates/times of the infusion. The actual infusion duration was derived by the sponsor in an ADaM dataset (not shown). The infusion was not interrupted. Because this is the first dose, ECINDADJ and ECFRQADJ are blank.
|Row 3:||This subject experienced a grade 4 toxicity. The prescribed dose (scheduled) was reduced by 50% and the infusion was delayed and planned to be given every 4 weeks with a planned time of 120 minutes. Since the infusion duration was changed, ECINDADJ represents the reason the duration was changed.|
|Row 4:||Shows the actual (performed) exposure information.|
The subject discontinued treatment. As required by this protocol, this row shows that the next scheduled dose is zero. The sponsor did not include a performed record, as no dose was administered.
|1||PACA014||EC||1400||1||1||TREATMENT||SCHEDULED||80||mg/m2||EVERY 2 WEEKS||INTRAVENOUS|
|3||PACA014||EC||1400||3||2||TREATMENT||SCHEDULED||40||mg/m2||EVERY 4 WEEKS||INTRAVENOUS||ADVERSE EVENT||TREATMENT||2020-08-28||PT120M||ADVERSE EVENT||ADVERSE EVENT|
|2020-08-28T08:00||2020-08-28T09:30||N||ADVERSE EVENT||ADVERSE EVENT|
EC NSV Metadata
|ECPLDUSA||Planned Duration Single Administration||text||Non-standard Record Qualifier||CRF|
|ECINFIRP||Infusion Interrupted||text||Non-standard Record Qualifier||CRF|
|ECINDADJ||Infusion Duration Adjustment Reason||text||Non-standard Record Qualifier||CRF|
|ECFRQADJ||Intervention Frequency Adjustment Reason||text||Non-standard Record Qualifier||CRF|
Upon unmasking, it became known that the subject was randomized to drug XYZ. The EX dataset shows the actual drug administrations in the protocol-specified unit, derived based on the total dose administered (represented in EC). Sponsors may decide to group these actual doses into prespecified categories/dose levels in ADaM. If a study does not collect the total dose in mg, the sponsor may represent the "scheduled" mg/m2 dosage in EX. Note that when single administrations were represented, EXDOSFRQ was not recorded. If multiple administrations are represented in a single row, EXDOSFRQ can be included.
|TREATMENT||2020-08-28T08:00||2020-08-28T09:30||2||2||PT120M||N||ADVERSE EVENT||ADVERSE EVENT|
EX NSV Metadata
|EXPLDUSA||Planned Duration Single Administration||text||Non-standard Record Qualifier||CRF|
|EXINFIRP||Infusion Interrupted||text||Non-standard Record Qualifier||CRF|
|EXINDADJ||Infusion Duration Adjustment Reason||text||Non-standard Record Qualifier||CRF|
|EXFRQADJ||Intervention Frequency Adjustment Reason||text||Non-standard Record Qualifier||CRF|
The RELREC dataset represents the relationship between EC and EX. The Adverse Events (AE) dataset is not shown.
Show the many-to-one relationship between records (both "SCHEDULED" and "PERFORMED") in EC and records in EX, using --LNKGRP.
|Rows 3-5:||Show the many-to-one relationship between AE, EX and EC. There may be many AEs linked to a dose record.|
|Rows 6-8:||Show the one-to-one relationship between VS, EX and EC.|