Analysis Data Model Implementation Guide for

Non-compartmental Analysis Input Data

Version 1.0 (Final)

Developed by the
CDISC Analysis Data Model Team

Notes to Readers

• This is the final Version 1.0 of the Analysis Data Model Implementation Guide for Non-compartmental
Analysis Input Data.
• This implementation guide applies the Analysis Data Model (ADaM) and ADaM Implementation
Guide to non-compartmental analysis (NCA) input data.

Revision History

Date Version
2021-11-29 1.0 Final

See Appendix C for representations and warranties, limitations of liability, and disclaimers.
CDISC Analysis Data Model Implementation Guide for Non-compartmental Analysis Input Data (1.0 Final)

CONTENTS
1 INTRODUCTION ................................................................................................................. 3

2 GENERAL OBJECTIVE OF NON-COMPARTMENTAL ANALYSIS ........................ 4

3 POINTS TO CONSIDER IN THIS DOCUMENT ............................................................. 5

4 ADAM METADATA ............................................................................................................ 7

4.1 DATASET METADATA............................................................................................................................................7
4.1.1 Define.xml Example Dataset Metadata ..................................................................................................7
4.2 VARIABLE METADATA ..........................................................................................................................................7

5 EXAMPLES ......................................................................................................................... 12

6 APPENDICES ...................................................................................................................... 20
APPENDIX A: ADAM ADNCA STANDARDS DEVELOPMENT TEAM ............................................................................. 20
APPENDIX B: GLOSSARY AND ABBREVIATIONS ........................................................................................................... 21
APPENDIX C: REPRESENTATIONS AND WARRANTIES, LIMITATIONS OF LIABILITY, AND DISCLAIMERS........................ 22

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1 Introduction
Pharmacokinetics (PK) is the study of the effect of the body on a drug. Different mathematical methods are used to
calculate PK parameters that describe, characterize, and quantify this effect. Non-compartmental analysis (NCA) is
one class of mathematical methods for studying the level of exposure following administration of a drug and is
commonly used to analyze serial drug concentration data from clinical trials by individual subjects.
The purpose of this document is to present the Analysis Data Model (ADaM) Basic Data Structure (BDS) as the
specification for the input dataset for NCA. The ADaM Implementation Guide (ADaMIG) for NCA datasets
specifies many of the variables needed for calculation of parameters using NCA and provides general naming
conventions that can be leveraged for additional variables. This document also provides provides specific guidance
for all commonly needed variables and should be viewed as the ADaM BDS class plus additional NCA variables.
NCA is typically performed using software packages designed to support PK analyses using drug concentration data
as one input. In addition, the input data format needs to comprehensively associate subject drug concentrations over
time with study drug dosing, support the exclusion of specific records and subjects, and provide other supporting
information as needed. The output from NCA (i.e., the PK parameter calculation per subject) is based on the specific
dosing regimen, the PK sample collection schedule, and the objective(s) associated with parameter calculations. The
PK parameter calculations are typically reported in the SDTM Pharmacokinetics Parameters (PP) domain and not a
part of this implementation guide.
The analysis data input for non-compartmental parameter calculation is subject to submission to regulatory bodies;
utilization of this standard format also promotes compliance with ADaM standards. It is important to build this
dataset based on Study Data Tabulation Model (SDTM) domains and, if applicable, on the other ADaM datasets
(e.g., the subject-level analysis dataset, ADSL) that will be submitted. CDISC foundational standards are available
at https://www.cdisc.org/standards.
In this document, the ADaM NCA dataset is simply referred to as an ADNCA dataset. It should be noted that this
does not imply required naming conventions. The NCA dataset should be named following the ADaM standard
naming convention, as described in https://www.cdisc.org/standards/foundational/adam.

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2 General Objective of Non-Compartmental

Analysis
Figure 2.1. PK Example

Pharmacokinetic (PK) non-compartmental analysis (NCA) is primarily a time-from-event-based analysis that

derives multiple parameters from time-concentration profiles for individual subjects. The ADNCA dataset structure
is designed to support commonly structured NCAs, including analyses with both discrete time-point measurements
(typical for plasma or serum) and measurements from collections over time intervals (typical for urine). The dataset
format is developed to support the more common structures for NCA programs but does not prevent additional
variables to accommodate more complex variants of or programming for NCA.
The ADNCA dataset structure may be used to create multiple tabular and graphical data presentations as they relate
to NCA and PK and pharmacodynamics data review, as well as provide a means to assess event collection
compliance where the data collected have a structured chronological sequence. In addition, the ADNCA structure
has the potential to be utilized for tabular and graphical data presentation in other PK and pharmacodynamic (PD;
the study of the effect of the drug on the body) sparse sampling study designs that do not necessarily require
NCA. The ADaM NCA dataset is not intended to be used for graphical and tabular presentations of results
from NCA (e.g., PK parameters such as maximum concentration and area under the curve) that are
tabulated in the SDTM Pharmacokinetics Parameters (PP) domain.

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3 Points to Consider in this Document

In reviewing the descriptions of the ADNCA dataset specifications and the examples presented in this document,
consider the following:
ADNCA datasets should be “analysis-ready”: This means they should contain the variables needed for the
intended use of performing non-compartmental analysis (NCA). The ADNCA dataset may be used to create tables,
listings, and figures for observed concentration time data, but this is not the primary purpose of the dataset. In
addition to required variables such as subject identifiers, treatment variables, and pharmacokinetic (PK) sample
variables, some critical variables included in the analysis dataset can be considered "study-specific" as they depend
on the specific nature of the disease or indication and the analyses planned in the protocol or statistical analysis plan
(SAP). Some variables may be populated by the PK scientist after the NCA is complete as these are meant to
document analysis-specific information. It is expected that this approach will be uncommon, but variables where this
method may be needed are referenced in the ADNCA metadata.
In addition, ADNCA datasets have the potential to be utilized for general PK analyses where NCA may not
necessarily be required, as many of the variables presented in the ADNCA specification are critical to assess PK
data for significant sampling or dosing-related deviations prior to generating statistical summaries, tables, figures,
and listings. At this time, the datasets used for general PK analyses are based on the application of ADaM standards
to the Pharmacokinetics Concentration (PC) domain, to create custom sponsor-defined analysis datasets. The
absence of a standard for a PK analysis dataset results in datasets that are not consistent across sponsors. This
document provides formal ADaM specification for non-compartmental PK analysis to establish consistency within
the field.
Identification of source dataset: When identifying the source dataset for a variable, the immediate predecessor is
used (see ADaM, https://www.cdisc.org/standards/foundational/adam). The dosing and subject-level datasets,
among others, are common input for many ADNCA variables, if they are available. Dosing datasets may include
SDTM exposure domains or a derived exposure dataset utilizing ADaM standards. If the subject-level analysis data
(ADSL) is not available or is not a viable option for the purposes of ADNCA generation, use the applicable SDTM
variables. Multiple CDISC source datasets may be used to populate ADNCA based on analysis need. Outside of the
SDTM PC domain, ADaM sources are expected to be the most common but may not be the only sources used to
create this dataset. All data sources used must be submitted to regulatory bodies. The NCA dataset structure can also
be leveraged for pharmacodynamics (PD) analysis where the primary dataset source is not PC. In that case it is
assumed that the relevant traceability variables and domain references will be included in place of PC.
As an example of identifying the source dataset for a variable, in ADSL the source of the SUBJID variable is
identified as DM.SUBJID in the analysis variable metadata. If in the ADNCA dataset AVAL (Analysis Value) is to
be supplied from the PC domain and SEX is to be supplied from the demographics domain, then the source is
identified as PC.PCSTRESN and DM.SEX, respectively.
• Rationale for requiring optional ADSL variables in the ADNCA dataset: It should be noted that select
variables in the ADNCA specification are derived from fields listed in ADSL as Optional but which are
listed as Required for ADNCA. Permissible ADSL variables required in ADNCA are scientifically
necessary to support PK analyses.
• Ordering of variables: ADaM (https://www.cdisc.org/standards/foundational/adam) states that the
ordering of variables in the analysis dataset should follow a logical ordering (not simply alphabetic). As
such, the specifications of the ADNCA dataset are ordered in a way that is sensible to the intended purpose
of the dataset, which is to support NCA. Within this document, however, no specific ordering of variables
within the illustrated datasets is applied; the tables shown only contain variables relevant to the example.
Within this document, the author of each example table applied his or her own logical ordering.
Examples are for illustration only: The examples in this document are intended only as illustrations and should not
be viewed as a statement of the standards themselves. In addition, the examples are intended to illustrate content and
not appearance; it is understood that there are many different ways that data and results can be displayed. This
document does not cover display formats.
• Display of metadata and dataset examples for illustration of content only: Although the metadata
elements have been defined in https://www.cdisc.org/standards/foundational/adam, how they are displayed
is a function of the mechanism used to display the content. Examples of datasets, formatting, and

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presentation styles used in this document are for the purposes of content illustration only, and are not
intended to imply any type of display standard or requirement.
• Examples not meant to be all-inclusive regarding variables: The examples in this document describe
some of the key variables and records that would be included in the ADNCA dataset. They are not intended
to illustrate every possible variable that might be included in the analysis dataset, as many variables are
dependent on specific study designs.
• No endorsement of vendors or products: In an effort to provide illustrations of the ADaM concepts, the
examples provided may reference specific programming languages. As with other ADaM documents,
references to specific vendor products are examples only and should not be interpreted as an endorsement
of these vendors or products.

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4 ADaM Metadata
The ADNCA dataset is designed to follow the ADaM BDS. More information about BDS can be found in ADaMIG
v1.2 (available at https://www.cdisc.org/standards/foundational/adam).

4.1 Dataset Metadata

Typically, the Analysis Dataset Metadata for an ADNCA dataset is specified as follows:
Table 4.1. Data Structure
Data Data Structure Class of Dataset SubClass of Dataset CDISC Notes
Structure Description
Name
ADNCA Basic Data Structure BASIC DATA NON- Dataset designed to support NCA . Primarily
Non-Compartmental STRUCTURE COMPARTMENTAL sourced from SDTM PC and supplemented
Analysis ANALYSIS by information from the EX, EC, or other relevant
domains.

The Data Structure Name, Data Structure Description, and CDISC Notes are intended to provide information to
assist producers in preparing their datasets and are not intended to be metadata submitted in define.xml.

4.1.1 Define.xml Example Dataset Metadata

Table 4.1.1 shows how dataset metadata are specified for NCA. This layout matches Define-XML v2.1 (available
at https://www.cdisc.org/standards/data-exchange/define-xml), which includes a methodology for representing
SubClass. NCA datasets are of the Class BASIC DATA STRUCTURE, SubClass NON-COMPARTMENTAL
ANALYSIS.
Text shown in italics is example content, and can be modified to fit the analysis dataset. All italicized text, including
dataset name and description (label), can be modified. In this example, "parameter" refers to analyte, "analysis visit"
refers to dose event, and "analysis timepoint" refers to sample.
Table 4.1.1. Define.xml Example Dataset Metadata
Dataset Description Class - SubClass Structure Purpose Keys Documentation Location
ADNCA Data for Non- BASIC DATA One record per subject Analysis STUDYID, See program... adnca.xpt
Compartmental STRUCTURE per parameter per USUBJID,
Analysis • NON- analysis visit per PARAMCD,
COMPARTMENTAL analysis timepoint AVISIT, ATPT
ANALYSIS

4.2 Variable Metadata

Because NCA data follows the BDS, most of the dataset variables can be found in ADaMIG v1.2, Section 3.3
(available at https://www.cdisc.org/standards/foundational/adam). Standard BDS and subject-level (ADSL)
variables that are commonly used in NCA include:
• STUDYID • APERIOD and APERIODC
• USUBJID and SUBJID • AVISIT* and AVISITN
• SITEID • ADT, ATM, and ADTM
• AGE or AAGE, and AGEU • ASTDT, ASTTM, and ASTDTM
• SEX • AENDT, AENTM, and AENDTM
• RACE • ATPT and ATPTN
• TRTP and TRTPN • PARAM, PARAMCD, and PARAMN
• TRTA and TRTAN • AVAL
• DOSEP*, DOSEA*, and DOSEU* • DTYP

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*BDS Variables DOSEA, DOSEU, and AVISIT have a different core value for NCA, as described in Table 4.2.2, Standard BDS Variables with Stronger Core
for Non-compartmental Analysis.
Additional standard dataset variables specific to NCA are specified in Table 4.2.1, New Standard Non-compartmental Analysis Variables.
Baseline characteristics are commonly needed in NCA, although they are often created in other datasets (e.g., ADSL). For tips for assembling names for these
non-standard variables (NSVs), see ADaMIG v1.2, Section 3.1. Common baseline characteristics for NCA include:
• BMIBL (body mass index, BMI, at baseline, associated with the time of reference dosing) and BMIBLU (units)
• HTBL (height at baseline, associated with the time of reference dosing) and HTBLU (units)
• WTBL (weight at baseline, associated with the time of reference dosing) and WTBLU (units)
Note that due to the needs of common analysis tools used for NCA, units for all baseline characteristics are usually stored in a separate variable, rather than as
part of the label.
ADaM variables are described here in tabular format. The two rightmost columns, Core and CDISC Notes, provide information about the variables to assist
producers in preparing their datasets. These columns are not meant to be metadata submitted in define.xml. The Core column describes whether a variable is
required, conditionally required, or permissible. The CDISC Notes column provides more information about the variable. In addition, the Type column specifies
whether the variable being described is character or numeric. A richer set of data types (e.g., text, integer, float), described in the Define-XML Specification
(available at https://www.cdisc.org/standards/data-exchange/define-xml), should be provided in the metadata by the producer.
Usage of the start and end datetimes in nominal or actual relative time calculation needs to be described in the define.
Table 4.2.1. New Standard Non-compartmental Analysis Variables
Variable Variable Label Type Codelist/ Core CDISC Notes
Name Controlled Terms
NCAXFL PK NCA Exclusion Flag Char Y Perm Flag for exclusion of a record into a PK NCA calculation (Y = exclusion, Null = inclusion)
NCAXFN PK NCA Exclusion Flag (N) Num 1 Perm Numeric flag for exclusion of a record into a PK NCA calculation (1 = exclusion, Null = inclusion).
NCAXFN can only be included if NCAXFL is also included.
NCAwXRS Reason w for PK NCA Char Perm This variable is used to explain why the record is not included in the PK NCA.
Exclusion
NCAwXRSN Reason for PK NCA Exclusion Num Perm This variable is used to explain why the record is not included in the PK NCA.
of w (N)
PKSUMXF PK Summary Exclusion Flag Char Y Perm Flag for exclusion of a record from a PK summary (1 = exclusion, Null = inclusion)
PKSUMXFN PK Summary Exclusion Flag Num 1 Perm Numeric flag for exclusion of a record from a PK summary (1 = exclusion, Null =
(N) inclusion). PKSUMXFN can only be included if PKSUMXFL is also included.
METABFL Metabolite Flag Char Y Cond Flag to designate if observations within a subject are associated with a metabolite. Required if parent
drug and metabolites are present in the dataset.
COHORT Subject Cohort Char Perm Relevant to trials where cohorts are defined. This could be another grouping not necessarily
associated with ARM.
COHORTN Subject Cohort (N) Num Perm Numeric representation of the COHORT variable. There must be a one-to-one mapping between
COHORT and COHORTN. When COHORT and COHORTN are present, then, on a given record,
either both must be populated or both must be null.
ROUTE Route Char (ROUTE) Perm Route of treatment delivery. This variable can be a copy of EX.EXROUTE or EC.ECROUTE. May
instead be derived from the EX.EXROUTE or EC.ECROUTE.
TRTRINT Planned Treatment Interval Num Perm Planned time between 2 consecutive treatments in multiple-dose studies (sometimes referred to as
"Tau")

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Variable Variable Label Type Codelist/ Core CDISC Notes

Name Controlled Terms
TRTRINTU Planned Treatment Interval Char (UNIT) Perm Units associated with TRTRINT
Units
DOSPCTDF Percent Diff. Nominal vs. Num Cond Derived variable using a standard percent difference formula: (100*(DOSEA-
Actual Dose DOSEP)/(DOSEP)). DOSPCTDF is required if both DOSEA and DOSEP are populated.
DOSEFRQ Dose Frequency Char (FREQ) Cond Usually expressed as the number of repeated administrations of DOSE within a specific time period
for multiple dose studies.
ACYCLE Analysis Cycle Num Perm This is a record-level identifier that reflects cycle and may be of particular importance for studies that
examine concentrations in cancer patients. There must be a one-to-one mapping between ACYCLE
and ACYCLEC. When ACYCLE and ACYCLEC are present, then, on a given record, either both
must be populated or both must be null.
ACYCLEC Analysis Cycle (C) Char Perm Character representation of the ACYCLE variable. Text characterizing to which analysis cycle the
record belongs. This is a record-level identifier that reflects cycle and may be of particular importance
for studies that examine concentrations in cancer patients. There must be a one-to-one mapping
between ACYCLE and ACYCLEC. When ACYCLE and ACYCLEC are present, then, on a given
record, either both must be populated or both must be null.
FANLDT First Date of Dose for Analyte Num Perm Date of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study
where multiple doses have been given. Note that FANLDT may not match TRTSDT or any of
TRxxSDT values.
FANLTM First Time of Dose for Analyte Num Perm Time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a study
where multiple doses have been given. If treatment is given over a duration multiple times, this
variable will reflect the start time of the first dose.
FANLDTM First Datetime of Dose for Num Perm Date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a
Analyte study where multiple doses have been given. If treatment is given over a duration multiple times, this
variable will reflect the start date and time of the first dose.
FANLEDT First End Date of Dose for Num Perm End date of first exposure to treatment associated with PARAM and ANALYTE for a subject in a
Analyte study where multiple doses have been given. Note that FANLEDT may not match TRTEDT or any of
TRxxEDT values.
FANLETM First End Time of Dose for Num Perm End time of first exposure to treatment associated with PARAM and ANALYTE for a subject in a
Analyte study where multiple doses have been given. If treatment is given over a duration multiple times, this
variable will reflect the end time of the first dose.
FANLEDTM First End Datetime of Dose for Num Perm End date and time of first exposure to treatment associated with PARAM and ANALYTE for a subject
Analyte in a study where multiple doses have been given. If treatment is given over a duration multiple times,
this variable will reflect the end date and time of the first dose.
PCRFTDT Reference Date of Dose for Num Req Date of reference exposure to treatment associated with PARAM and ANALYTE. Based on
Analyte PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is
typically the start of the dosing duration.
PCRFTTM Reference Time of Dose for Num Req Time of reference exposure to treatment associated with PARAM and ANALYTE. Based on
Analyte PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is
typically the start of the dosing duration.
PCRFTDTM Reference Datetime of Dose Num Req Date and time of reference exposure to treatment associated with PARAM and ANALYTE. Based on
for Analyte PC.PCRFTDTC and related to the analyzed profile. If this is a treatment over time, then this is
typically the start of the dosing duration.
PCRFEDT Reference End Date of Dose Num Cond The end date of reference exposure to treatment associated with PARAM and ANALYTE. Must be
for Analyte related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over an
interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be
filled out.
PCRFETM Reference End Time of Dose Num Cond The end time of the reference exposure to treatment associated with PARAM and ANALYTE. Must
for Analyte be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If dosing occurs over
an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU are required to be
filled out.

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Variable Variable Label Type Codelist/ Core CDISC Notes

Name Controlled Terms
PCRFEDTM Ref. End Datetime of Dose for Num Cond The end date and time of the reference exposure to treatment associated with PARAM and
Analyte ANALYTE. Must be related to the time recorded in PC.PCRFTDTC and to the analyzed profile. If
dosing occurs over an interval, this should be populated. If populated, ADOSEDUR and DOSEDURU
are required to be filled out.
NFRLT Nom. Rel. Time from Analyte Num Perm This is the planned elapsed time (for sample point or start of sampling interval) from first exposure to
First Dose treatment associated with PARAM and ANALYTE. For studies with an extended duration infusion,
use the define to document if this is from the start or end of the infusion.
AFRLT Act. Rel. Time from Analyte Num Perm This is the actual elapsed time (for sample point or start of sampling interval) from first exposure to
First Dose treatment associated with PARAM and ANALYTE. Note that this is referring to the first dose available
for a particular drug. It is useful in multiple-dosing situations.
NEFRLT Nom. Rel. End Time from First Num Perm This is the planned elapsed end time of sampling interval from first exposure to study treatment.
Dose
AEFRLT Act. Rel. End Time from First Num Perm This is the actual elapsed end time of sampling interval from first exposure to study treatment.
Dose
FRLTU Rel. Time from First Dose Unit Char (PKUNIT) Perm This is the unit for all elapsed times from first dose.
NRRLT Nominal Rel. Time from Ref. Num Req This is the planned elapsed time (for sample point or start of sampling interval) from reference
Dose exposure to study treatment.
ARRLT Actual Rel. Time from Ref. Num Req This is the actual elapsed time (for sample point or start of sampling interval) from reference
Dose exposure to study treatment.
MRRLT Modified Rel. Time from Ref. Num Perm This variable could be used to modify the ARRLT variable based on analysis needs (e.g., setting
Dose negative values to zero or having a mix of nominal and actual time based of TMPCTDF).
NERRLT Nominal Rel. End Time from Num Perm This is the planned elapsed end time of sampling interval from reference exposure to study
Ref. Dose treatment.
AERRLT Actual Rel. End Time from Ref. Num Perm This is the actual elapsed end time of sampling interval from reference exposure to study treatment.
Dose
MERRLT Modified Rel. End Time from Num Perm This variable could be used to modify the AERRLT variable based on analysis needs (e.g., setting
Ref. Dose negative values to zero or having a mix of nominal and actual time based on TMPCTDF).
RRLTU Rel. Time from Ref. Dose Unit Char (PKUNIT) Req This is the unit for all elapsed times from reference dose.
TMPCTDF Percent Diff. Nominal vs. Num Perm This is the percent difference between nominal and actual time. It is derived by using the standard
Actual Time percent difference formula: 100*( NRRLT - ARRLT)/( NRRLT).
ADOSEDUR Actual Duration of Treatment Num Cond Total treatment duration, as measured in units given in DOSEDURU, derived from PCRFEDTM-
Dose PCRFDTM. This record is generally considered to be associated with an infusion dose and is distinct
from TRTDURD, TRTDURM, and TRTDURY, which reference the duration of the entire study rather
than the duration of a single treatment event.
NDOSEDUR Nominal duration of Treatment Num Cond Nominal treatment duration as specified in the protocol, as measured in units given in
Dose DOSEDURU. This record is generally considered to be associated with an infusion dose.
DOSEDURU Duration of Treatment Dose Char (PKUNIT) Perm Units associated with ADOSEDUR and NDOSEDUR. When ADOSEDUR is present, NDOSEDUR
Units and/or DOSEDURU must also be included in the dataset.
AVALU Analysis Value Unit Char Req Unit for AVAL.
PCSPEC Specimen Material Type Char (SPECTYPE) Perm Defines the type of specimen used for a measurement (e.g., SERUM, PLASMA, URINE). This
column must be a direct copy of PC.PCSPEC.
PCSTRESC Character Result/Finding in Std Char Cond Character results/findings in a standard format. The purpose of this column is to capture which
Format records are BLQ or LLOQ in the AVAL column. This column must be a direct copy of
PC.PCSTRESC.
PCSTRESU Standard Units Char (UNIT) Cond Standardized unit associated with AVAL. Units associated with AVAL are needed for clear NCAs.
This column must be a direct copy of PC.PCSTRESU.
ALLOQ Analysis Lower Limit of Num Cond Indicates the lower limit of quantitation for an assay. Use if PC.PCLLOQ does not support analysis
Quantitation needs.
PCLLOQ Lower Limit of Quantitation Num Cond Indicates the lower limit of quantitation for an assay. Must be a direct copy of PC.PCLLOQ.

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Variable Variable Label Type Codelist/ Core CDISC Notes

Name Controlled Terms
VOLUME Volume Value Num Cond PC.PCSTRESN from a PC volume record. This is the volume related to AVAL. Conditionally required
if sample is interval-based collection, such as urine.
VOLUMEU Volume Value Unit Char (UNIT) Cond PC.PCSTRESU from a PC volume record. Conditionally required if VOLUME is present.
SPWEIGHT Specimen Weight Value Num Cond PC.PCSTRESN from a PC specimen weight record, adjustment based on LLOQ rules possible. This
is the specimen weight associated with AVAL. Conditionally required if sample is interval based
collection, such as a potential non-fluid matrix (e.g., feces).
SPWEIGHU Specimen Weight Value Unit Char (UNIT) Cond PC.PCSTRESU from a PC weight record. Conditionally required if SPWEIGHT is present.
PCGRPID Group ID Char Perm Used to tie together a block of related records in a single domain to support relationships within the
domain and between domains. Must be a direct copy of PC.PCGRPID.
PCSEQ Sequence Number Num Cond PC.PCSEQ associated with AVAL.

Table 4.2.2. Standard BDS Variables with Stronger Core for Non-Compartmental Analysis
The following variables are described in the ADaMIG, but are not required for general BDS use. However, for NCA use, they are required. The only difference
between these variables and what is in the ADaMIG is the value for Core.
Variable Variable Label Type Codelist/ Core CDISC Notes
Name Controlled Terms
DOSEA Actual Treatment Dose Num Req DOSEA represents the actual treatment dosage associated with the record. This is the actual
numeric amount of the dose used for the NCA analysis and may differ from the EX.EXDOSE.
DOSEU Treatment Dose Units Char (UNIT) Req The units for DOSEP and DOSEA. It is permissible to use suffixes such as “P” and “A” to record
different units for DOSEP and DOSEA, with labels modified accordingly.
AVISIT Analysis Visit Char Req The analysis visit description; required if an analysis is done by nominal, assigned or analysis visit.
AVISIT may contain the visit names as observed (i.e., from SDTM VISIT), derived visit names, time
window names, conceptual descriptions (such as Average, Endpoint, etc.), or a combination of any of
these. AVISIT is a derived field and does not have to map to VISIT from the SDTM. AVISIT
represents the analysis visit of the record, but it does not mean that the record was analyzed. There
are often multiple records for the same subject and parameter that have the same value of AVISIT.
ANLzzFL and other variables may be needed to identify the records selected for any given analysis.
See ADaMIG v1.2, Section 3.3.8, for information about flag variables. AVISIT should be unique for a
given analysis visit window. In the event a record does not fall within any predefined analysis time-
point window, AVISIT can be populated in any way that the producer chooses to indicate this fact
(i.e., blank or “Not Windowed”). The way that AVISIT is calculated, including the variables used in its
derivation, should be indicated in the variable metadata for AVISIT. The values and the rules for
deriving AVISIT may be different for different parameters within the same dataset. Values of AVISIT
are producer-defined and are often directly usable in clinical study report (CSR) displays.

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5 Examples
Timing
Example 1: Difference Between AVISIT in ADNCA and "Day" Variables in SDTM
The AVISIT variable in ADNCA is useful for pharmacokinetic (PK) analysis in many situations. For example, it is
used as a key variable to extract the concentration-time profiles for different days in multiple-day studies.
When deriving the AVISIT and AVISITN variables from tabulated variables in SDTM domains, the following
example shows how the AVISIT variable is different from the PCDY variable in the pharmacokinetic concentrations
(PC) domain of SDTM. Similar considerations will apply to VISIT variables in SDTM domains.
The PCDY variable indicates the study day when the sample was taken. This variable is one of the timing variables
for the specific observations in the records of the PC domain dataset. This example shows that for the samples taken
24, 36, and 48 hours after dosing, the PCDY variable correctly indicates that these are days 2 and 3 of the study.
However, with respect to the concentration-time profile for PK analysis, the AVISIT variable needs to indicate that
these samples are part of the profile that is related to the day 1 dose. So, the AVISIT variable should have a value of
“DAY 1” and corresponding AVISITN has the value of “1”.
pc.xpt adnca.xpt
PCDY PCTPT PCRFTDTC PCRFTDTM AVISIT AVISITN
1 PREDOSE 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 30MIN 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 1H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 2H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 4H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 8H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
1 12H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
2 24H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
2 36H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1
3 48H 2011-12-26T08:00 2011-12-26T08:00:00 DAY 1 1

Example 2: Timing and Values for Multiple Oral Dosing

This example shows the nominal and relative times for a multiple oral-dosing trial.
Note that the modified relative time from reference dose (MRRLT) was added for analysis purposes: the negative
ARRLT on rows 1 and 8 is assigned zero, as PK software such as Phoenix WNL will only include observations
starting from dosing, and not prior to dosing, for parameter estimation.
This table shows the following situation:
Rows 1-7: A pre-dose sample is recorded in row 1 (planned for 15AUG15:09:00, taken at 15AUG15:08:30). For
the samples after the initial dose (rows 2-7), the values of the timing variables relative to the first dose
(NFRLT and AFRLT) are the same as the values of the timing variables relative to the reference dose
(NRRLT and ARRLT).
Rows 8-14: A pre-dose sample (relative to the day 6 dose) is recorded in row 8. For the samples after day 6 pre-
dose (rows 9-14), the values of the timing variables relative to the first dose (NFRLT and AFRLT)
record the time since administration of the day 1 dose whereas the values of the timing variables
(NRRLT and ARRLT) are relative to the day 6 reference dose.
adnca.xpt
Row ATPTREF ATPT ADTM PCRFTDTM NFRLT AFRLT NRRLT ARRLT MRRLT FRLTU RRLTU AVAL
1 DAY 1 Predose 15AUG15:08:30 15AUG15:09:00 0.00 -0.50 0.00 -0.50 0.00 h h 0
2 DAY 1 0.5 H 15AUG15:09:30 15AUG15:09:00 0.50 0.50 0.50 0.50 0.50 h h 5.168
3 DAY 1 1H 15AUG15:10:00 15AUG15:09:00 1.00 1.00 1.00 1.00 1.00 h h 18.020
4 DAY 1 2H 15AUG15:11:03 15AUG15:09:00 2.00 2.05 2.00 2.05 2.05 h h 31.580
5 DAY 1 4H 15AUG15:13:00 15AUG15:09:00 4.00 4.00 4.00 4.00 4.00 h h 18.500
6 DAY 1 6H 15AUG15:15:00 15AUG15:09:00 6.00 6.00 6.00 6.00 6.00 h h 16.700
7 DAY 1 24 H 16AUG15:08:53 15AUG15:09:00 24.00 24.88 24.00 23.88 23.88 h h 0.656
8 DAY 6 Predose 21AUG15:08:53 21AUG15:09:00 192.00 191.88 0.00 -0.12 0.00 h h 1.544

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Row ATPTREF ATPT ADTM PCRFTDTM NFRLT AFRLT NRRLT ARRLT MRRLT FRLTU RRLTU AVAL
9 DAY 6 0.5 H 21AUG15:09:30 21AUG15:09:00 192.50 192.50 0.50 0.50 0.50 h h 2.216
10 DAY 6 1H 21AUG15:10:02 21AUG15:09:00 193.00 193.03 1.00 1.03 1.03 h h 6.008
11 DAY 6 2H 21AUG15:11:10 21AUG15:09:00 194.00 194.17 2.00 2.17 2.17 h h 32.400
12 DAY 6 4H 21AUG15:13:00 21AUG15:09:00 196.00 196.00 4.00 4.00 4.00 h h 22.940
13 DAY 6 6H 21AUG15:15:00 21AUG15:09:00 198.00 198.00 6.00 6.00 6.00 h h 23.540
14 DAY 6 24 H 22AUG15:08:53 21AUG15:09:00 216.00 215.88 24.00 23.88 23.88 h h 1.724

Dosing Variables
The following are examples of the different dosing variables that can be used in ADNCA. These variables are
available to document specific details of each reference dose, including the planned and actual dose amount and the
dosing frequency and interval.
Example 1: Multiple Oral Dosing with Record Inclusion Determined by Actual Dose Received
Row 1: Dosing at day 1. These dosing variables will be present in the ADNCA where the reference treatment
is the administration on 12AUG2015.
Row 2: Dosing at day 2. These dosing variables will be present in the ADNCA where the reference treatment
is the administration on 13AUG2015. Note that an incomplete dose was taken. Observations linked to
this administration can be excluded with the exclusion flags (see Exclusion Flags Example 1, below).
Row 3: Dosing at day 7. These dosing variables will be present in the ADNCA where the reference treatment
is the administration on 18AUG2015.
adnca.xpt
Row USUBJID FANLDTM PCRFTDTM DOSETRT AVISIT DOSEP DOSEA DOSEU DOSPCTDF DOSEFRQ TRTRINT TRTRINTU
1 001 12AUG15:09:00 12AUG15:09:00 DRUGX DAY 1 10 10 mg 0 QD 24 h
2 001 12AUG15:09:00 13AUG15:09:00 DRUGX DAY 2 10 8 mg 20 QD 24 h
3 001 12AUG15:09:00 18AUG15:09:00 DRUGX DAY 7 10 10 mg 0 QD 24 h

Example 2: Infusion
Row 1: Infusion at day 1. These dosing variables will be present in the ADNCA for subject 001 for every
record where the reference treatment is the infusion on 12AUG2015.
Row 2: Infusion at day 1. These dosing variables will be present in the ADNCA for subject 002 for every
record where the reference treatment is the infusion on 12AUG2015.
Row 3: Infusion at day 1. These dosing variables will be present in the ADNCA for subject 003 for every
record where the reference treatment is the infusion on 12AUG2015. Note that the infusion was
stopped after 30 minutes. Observations linked to this infusion can be excluded with the exclusion flags
(see Exclusion Flags Example 1, below).
adnca.xpt
Row USUBJID PCRFTDTM PCRFEDTM DOSETRT AVISIT DOSEP DOSEA DOSEU DOSPCTDF DOSEDUR DOSEDURU
1 001 12AUG15:09:00 12AUG15:10:00 DRUGX DAY 1 10 10 mg/kg 0 1.00 h
2 002 12AUG15:09:10 12AUG15:10:10 DRUGX DAY 1 10 10 mg/kg 0 1.00 h
3 003 12AUG15:09:20 12AUG15:09:50 DRUGX DAY 1 10 5 mg/kg 50 0.50 h

Exclusion Flags
The following are examples of the use of the exclusion flags NCAXFL (for record-level exclusions). The examples
show exclusions for reasons that are mainly triggered by considerations around sampling. Other exclusion reasons
(e.g., exclusions caused by some violation of dosing requirements) would be referenced accordingly. These
variables provide clarity on which intensive PK samples were not included in NCA along with a brief description
why, and can be utilized by regulatory agencies during regulatory filings and/or study review.
Example 1: Record-level Exclusions
The table below shows 3 examples for record-level exclusions.
Rows 1-4: These records were included in the analysis.
Row 5: This record for subject CPW-s001 at nominal time 2 hours is excluded because no concentration
value is available. The record should still be included in the dataset for traceability reasons and to
support consistent reporting. Therefore, NCAXFL is set to “Y” and NCA1XRS is set to “Missing
AVAL Value”.

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Rows 6-12: These records were included in the analysis.

Row 13: This record for subject CPW-s002 at nominal time 4 hours is excluded because the sample was taken outside the time window considered
acceptable by the data scientist/analyst. Therefore, NCAXFL is set to “Y” and NCA2XRS set to “Late Sample”.
Row 14: This record was included in the analysis.
Rows 15-21: The records for subject CPW-s003 after the dose at time 0 hours are all excluded because the subject vomited too soon after the dose
administration. Therefore, NCAXFL is set to “Y” and NCA3XRS set to “Vomiting” for all records for this profile.
adnca.xpt
Row STUDYID USUBJID ARRLT NRRLT RRLTU AVAL PCSTRESU VOMITFL VRLT NCAXFL NCAXFN NCA1XRS NCA2XRS NCA3XRS
1 CPW CPW-s001 0 0 h 0 ug/L Y 0.75
2 CPW CPW-s001 0.33333 0.25 h 19.4 ug/L Y 0.75
3 CPW CPW-s001 0.5 0.5 h 118.8 ug/L Y 0.75
4 CPW CPW-s001 1 1 h 115 ug/L Y 0.75
5 CPW CPW-s001 2 2 h ug/L Y 0.75 Y 1 Missing AVAL Value
6 CPW CPW-s001 4 4 h 91.2 ug/L Y 0.75
7 CPW CPW-s001 8 8 h 67.6 ug/L Y 0.75
8 CPW CPW-s002 0 0 h 0 ug/L
9 CPW CPW-s002 0.25 0.25 h 18.4 ug/L
10 CPW CPW-s002 0.5 0.5 h 114 ug/L
11 CPW CPW-s002 1 1 h 115 ug/L
12 CPW CPW-s002 2 2 h 114 ug/L
13 CPW CPW-s002 5 4 h 72 ug/L Y 1 Late Sample
14 CPW CPW-s002 8 8 h 59.15 ug/L
15 CPW CPW-s003 0 0 h 0 ug/L Y 0.083333 Y 1 Vomiting
16 CPW CPW-s003 0.4 0.25 h 19.8 ug/L Y 0.083333 Y 1 Vomiting
17 CPW CPW-s003 0.75 0.5 h 126 ug/L Y 0.083333 Y 1 Vomiting
18 CPW CPW-s003 1.33333 1 h 131.25 ug/L Y 0.083333 Y 1 Vomiting
19 CPW CPW-s003 2 2 h 114 ug/L Y 0.083333 Y 1 Vomiting
20 CPW CPW-s003 4 4 h 97.85 ug/L Y 0.083333 Y 1 Vomiting
21 CPW CPW-s003 7 8 h 68.25 ug/L Y 0.083333 Y 1 Vomiting

Example 2: Record-level Exclusion for a Subject

The following table shows an example for record-level exclusion. For an entire subject all subject observations need to be flagged.
Row 1: This record was included in the analysis.
Row 2: This record for subject CPW-s011 at nominal time 0.25 hours is excluded because the sample was taken too late. Therefore, NCAXFL is set to
"Y" and NCA1XRS is set to "Late Sample".
Rows 3-14: These records were included in the analysis.
Rows 15-21: All records for subject CPW-s013 are excluded because there are not enough data for PK analysis for day 1. In this particular case, it was also
decided not to analyze any of the data for this subject, including the complete profile that is available for day 7. Therefore, NCAXFL is equal to
"Y" and NCA2XRS is set to "Incomp. Day 1 Samples".
Rows 22-35: These records were included in the analysis.

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Rows 36-42: All records for subject CPW-s013 are excluded because there are not enough data for PK analysis for day 1. In this particular case, it was also
decided not to analyze any of the data for this subject, including the complete profile that is available for day 7. Therefore, NCAXFL is equal to
"Y" and NCA2XRS is set to "Incomp. Day 1 Samples".
adnca.xpt
Row STUDYID USUBJID TRTAN ARRLT NRRLT RRLTU ATPTREF AVAL PCSTRESU NCAXFL NCAXFN NCA1XRS NCA2XRS
1 CPW CPW-s011 1 0 0 h 1 0 ug/L
2 CPW CPW-s011 1 0.4 0.25 h 1 80.3 ug/L Y 1 Late Sample
3 CPW CPW-s011 1 0.5 0.5 h 1 118.8 ug/L
4 CPW CPW-s011 1 1 1 h 1 115 ug/L
5 CPW CPW-s011 1 2 2 h 1 132 ug/L
6 CPW CPW-s011 1 4 4 h 1 91.2 ug/L
7 CPW CPW-s011 1 8 8 h 1 67.6 ug/L
8 CPW CPW-s012 1 0 0 h 1 0 ug/L
9 CPW CPW-s012 1 0.4 0.25 h 1 19.8 ug/L
10 CPW CPW-s012 1 0.75 0.5 h 1 126 ug/L
11 CPW CPW-s012 1 1.33333 1 h 1 131.25 ug/L
12 CPW CPW-s012 1 2 2 h 1 114 ug/L
13 CPW CPW-s012 1 4 4 h 1 97.85 ug/L
14 CPW CPW-s012 1 7 8 h 1 68.25 ug/L
15 CPW CPW-s013 1 0 0 h 1 0 ug/L Y 1 Incomp. Day 1 Samples
16 CPW CPW-s013 1 0.25 0.25 h 1 19.8 ug/L Y 1 Incomp. Day 1 Samples
17 CPW CPW-s013 1 0.5 0.5 h 1 ug/L Y 1 Incomp. Day 1 Samples
18 CPW CPW-s013 1 1 1 h 1 ug/L Y 1 Incomp. Day 1 Samples
19 CPW CPW-s013 1 2 2 h 1 ug/L Y 1 Incomp. Day 1 Samples
20 CPW CPW-s013 1 4 4 h 1 ug/L Y 1 Incomp. Day 1 Samples
21 CPW CPW-s013 1 7 8 h 1 ug/L Y 1 Incomp. Day 1 Samples
22 CPW CPW-s011 1 0 0 h 7 0 ug/L
23 CPW CPW-s011 1 0.2 0.25 h 7 28.13 ug/L
24 CPW CPW-s011 1 0.5 0.5 h 7 160.38 ug/L
25 CPW CPW-s011 1 1 1 h 7 207 ug/L
26 CPW CPW-s011 1 2 2 h 7 211.2 ug/L
27 CPW CPW-s011 1 4 4 h 7 114 ug/L
28 CPW CPW-s011 1 8 8 h 7 74.36 ug/L
29 CPW CPW-s012 1 0 0 h 7 0 ug/L
30 CPW CPW-s012 1 0.25 0.25 h 7 54.89 ug/L
31 CPW CPW-s012 1 0.45 0.5 h 7 69.3 ug/L
32 CPW CPW-s012 1 1.33333 1 h 7 108.2813 ug/L
33 CPW CPW-s012 1 2 2 h 7 71.25 ug/L
34 CPW CPW-s012 1 4 4 h 7 80.72625 ug/L
35 CPW CPW-s012 1 7 8 h 7 56.30625 ug/L
36 CPW CPW-s013 1 0 0 h 7 0 ug/L Y 1 Incomp. Day 1 Samples
37 CPW CPW-s013 1 0.25 0.25 h 7 19.03 ug/L Y 1 Incomp. Day 1 Samples
38 CPW CPW-s013 1 0.5 0.5 h 7 166.25 ug/L Y 1 Incomp. Day 1 Samples
39 CPW CPW-s013 1 1 1 h 7 163.28 ug/L Y 1 Incomp. Day 1 Samples
40 CPW CPW-s013 1 2 2 h 7 159.6 ug/L Y 1 Incomp. Day 1 Samples
41 CPW CPW-s013 1 4 4 h 7 137.75 ug/L Y 1 Incomp. Day 1 Samples
42 CPW CPW-s013 1 8 8 h 7 89.6 ug/L Y 1 Incomp. Day 1 Samples

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Flags for Recording Meals and Vomiting by Subjects

The ADNCA specification contains variables that allow data scientists to describe that a subject consumed a meal within a defined time window of the dose or
that a subject vomited after dose administration. By including this information in the PK analysis dataset, scientists can analyze whether a meal or vomiting has a
significant effect on the pharmacokinetic characteristics of a drug. Specific details relating timing of meals, vomit or emesis, or any event that would deem the
concentration record unusable should be provided in the define.
Example 1: Handling Meal Data
This table shows how data are represented when certain subjects have a meal within a specified time window.
Rows 1-7: Subject CPW-s001 had a meal before the dose administration. NCAXFL is set to “Y” and NCA1XRS is set to "No Meal".
Rows 8-14: Subject CPW-s002 had no meal. NCAXFL is set blank and NCA1XRS is empty.
Rows 15-21: Subject CPW-s003 had a meal just after the dose administration. NCAXFL is set to “Y” and NCA1XRS is set to "No Meal".
adnca.xpt
Row STUDYID USUBJID ARRLT NRRLT RRLTU AVAL PCSTRESU NCAXFL NCA1XRS DOSEP DOSEU
1 CPW CPW-s001 0 0 h 0 ug/L Y No Meal 30 mg
2 CPW CPW-s001 0.33333 0.25 h 19.4 ug/L Y No Meal 30 mg
3 CPW CPW-s001 0.5 0.5 h 118.8 ug/L Y No Meal 30 mg
4 CPW CPW-s001 1 1 h 115 ug/L Y No Meal 30 mg
5 CPW CPW-s001 2 2 h 132 ug/L Y No Meal 30 mg
6 CPW CPW-s001 4 4 h 91.2 ug/L Y No Meal 30 mg
7 CPW CPW-s001 8 8 h 67.6 ug/L Y No Meal 30 mg
8 CPW CPW-s002 0 0 h 0 ug/L 30 mg
9 CPW CPW-s002 0.25 0.25 h 18.4 ug/L 30 mg
10 CPW CPW-s002 0.5 0.5 h 114 ug/L 30 mg
11 CPW CPW-s002 1 1 h 115 ug/L 30 mg
12 CPW CPW-s002 2 2 h 114 ug/L 30 mg
13 CPW CPW-s002 5 4 h 72 ug/L 30 mg
14 CPW CPW-s002 8 8 h 59.15 ug/L 30 mg
15 CPW CPW-s003 0 0 h 0 ug/L Y No Meal 30 mg
16 CPW CPW-s003 0.4 0.25 h 65 ug/L Y No Meal 30 mg
17 CPW CPW-s003 0.75 0.5 h 126 ug/L Y No Meal 30 mg
18 CPW CPW-s003 1.33333 1 h 131.25 ug/L Y No Meal 30 mg
19 CPW CPW-s003 2 2 h 114 ug/L Y No Meal 30 mg
20 CPW CPW-s003 4 4 h 97.85 ug/L Y No Meal 30 mg
21 CPW CPW-s003 7 8 h 68.25 ug/L Y No Meal 30 mg

Example 2: Handling Vomit Data

This table shows how data are represented when certain subjects vomit after drug administration.
Rows 1-7: Subject CPW-s011 did not vomit. NCAXFL and NCA1XRS are empty.
Rows 8-14: Subject CPW-s012 vomited after the dose administration. NCAXFL is set to “Y” and NCA1XRS is set to "Vomit". Note that, at the time of
vomiting, most of the drug was already absorbed; only little effect on the PK profile would be expected.

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Rows 15-21: Subject CPW-s013 vomited after the dose administration. NCAXFL is set to “Y” and NCA1XRS is set to "Vomit". In this case, most of the drug
was not absorbed and the observed drug concentration is significantly lower than expected without vomiting.
adnca.xpt
Row STUDYID USUBJID ARRLT NRRLT RRLTU AVAL PCSTRESU NCAXFL NCA1XRS DOSEP DOSEU
1 CPW CPW-s011 0 0 h 0 ug/L 30 mg
2 CPW CPW-s011 0.33333 0.25 h 19.4 ug/L 30 mg
3 CPW CPW-s011 0.5 0.5 h 118.8 ug/L 30 mg
4 CPW CPW-s011 1 1 h 115 ug/L 30 mg
5 CPW CPW-s011 2 2 h 132 ug/L 30 mg
6 CPW CPW-s011 4 4 h 91.2 ug/L 30 mg
7 CPW CPW-s011 8 8 h 67.6 ug/L 30 mg
8 CPW CPW-s012 0 0 h 0 ug/L Y Vomit 30 mg
9 CPW CPW-s012 0.25 0.25 h 18.4 ug/L Y Vomit 30 mg
10 CPW CPW-s012 0.5 0.5 h 114 ug/L Y Vomit 30 mg
11 CPW CPW-s012 1 1 h 103.5 ug/L Y Vomit 30 mg
12 CPW CPW-s012 2 2 h 102.6 ug/L Y Vomit 30 mg
13 CPW CPW-s012 4.5 4 h 85.5 ug/L Y Vomit 30 mg
14 CPW CPW-s012 8 8 h 53.235 ug/L Y Vomit 30 mg
15 CPW CPW-s013 0 0 h 0 ug/L Y Vomit 30 mg
16 CPW CPW-s013 0.4 0.25 h 49.9 ug/L Y Vomit 30 mg
17 CPW CPW-s013 0.75 0.5 h 63 ug/L Y Vomit 30 mg
18 CPW CPW-s013 1.33333 1 h 65.625 ug/L Y Vomit 30 mg
19 CPW CPW-s013 2 2 h 57 ug/L Y Vomit 30 mg
20 CPW CPW-s013 4 4 h 48.925 ug/L Y Vomit 30 mg
21 CPW CPW-s013 7 8 h 34.125 ug/L Y Vomit 30 mg

Urine Data
Example 1: Urine Data
This example shows the nominal and relative start and end times of urine sampling for a multiple oral dosing trial for 1 subject. ARRLT, AERRLT, AVAL, and
VOLUME can directly be used in PK software to calculate the urinary PK parameters.
Note that MRRLT can be added for analysis purposes: the negative ARRLT on row 2 and row 6 can be put to zero; PK software such as Phoenix WNL will only
include observations starting from dosing, and not prior to dosing, for parameter estimation.
Rows 1-5: These are rows containing urine sampling related to administration on 12AUG2015.
Rows 6-11: These are rows containing urine sampling related to administration on 18AUG2015.
adnca.xpt
Row PARAM PCRFTDTM ASTDTM AENDTM NRRLT ARRLT NERRLT AERRLT RRLTU ATPTREF ATPT AVAL PCSTRESN PCSTRESU VOLUME VOLUMEU
Urine
-24 to
1 Amount 12AUG15:09:00 11AUG15:08:51 12AUG15:08:50 -24 -24.15 0 -0.17 h Day 1 0 0 ug/L 2464 mL
0h
(ug)
Urine
0 to 4
2 Amount 12AUG15:09:00 12AUG15:08:50 12AUG15:13:06 0 -0.17 4 4.1 h Day 1 379940 628 ug/L 605 mL
h
(ug)

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Row PARAM PCRFTDTM ASTDTM AENDTM NRRLT ARRLT NERRLT AERRLT RRLTU ATPTREF ATPT AVAL PCSTRESN PCSTRESU VOLUME VOLUMEU
Urine
4 to 8
3 Amount 12AUG15:09:00 12AUG15:13:06 12AUG15:17:05 4 4.1 8 8.08 h Day 1 110143 527 ug/L 209 mL
h
(ug)
Urine
8 to 12
4 Amount 12AUG15:09:00 12AUG15:17:05 12AUG15:21:06 8 8.08 12 12.1 h Day 1 63712 362 ug/L 176 mL
h
(ug)
Urine
12 to
5 Amount 12AUG15:09:00 12AUG15:21:06 18AUG15:08:50 12 12.1 24 23.83 h Day 1 605220 786 ug/L 770 mL
24 h
(ug)
Urine
0 to 4
6 Amount 12AUG15:09:00 18AUG15:08:50 18AUG15:13:05 0 -0.17 4 4.08 h Day 7 328779 729 ug/L 451 mL
h
(ug)
Urine
4 to 8
7 Amount 12AUG15:09:00 18AUG15:13:05 18AUG15:17:08 4 4.08 8 8.13 h Day 7 57860 526 ug/L 110 mL
h
(ug)
Urine
8 to 12
8 Amount 12AUG15:09:00 18AUG15:17:08 18AUG15:21:10 8 8.13 12 12.17 h Day 7 73568 352 ug/L 209 mL
h
(ug)
Urine
12 to
9 Amount 12AUG15:09:00 18AUG15:21:10 19AUG15:09:09 12 12.17 24 24.15 h Day 7 780120 788 ug/L 990 mL
24 h
(ug)
Urine
24 to
10 Amount 12AUG15:09:00 19AUG15:09:09 20AUG15:09:05 24 24.15 48 48.08 h Day 7 308935 205 ug/L 1507 mL
48 h
(ug)
Urine
48 to
11 Amount 12AUG15:09:00 20AUG15:09:05 21AUG15:09:05 48 48.08 72 72.08 h Day 7 152724 156 ug/L 979 mL
72 h
(ug)

Example 2: Urine and Plasma PARAM and PARAMCD Variables

The purpose of the PARAM variable is to completely describe the value found in AVAL and, therefore, it is important that the PARAM value also include
information on the units and the specimen type (if applicable). This example shows how the PARAM and PARAMCD variables should be handled when the
dataset contains both urine and plasma samples that are both measuring analyte A.
adnca.xpt
Row USUBJID PARAM PARAMCD NRRLT NERRLT RRLTU ATPT PCSPEC AVAL PCSTRESU
1 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 0 h Predose PLASMA 0 ug/L
2 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 0.5 h 0.5 H PLASMA 115 ug/L
3 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 2 h 2H PLASMA 1320 ug/L
4 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 4 h 4H PLASMA 1450 ug/L
5 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 8 h 8H PLASMA 2119 ug/L
6 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 12 h 12 H PLASMA 2427 ug/L
7 STD1-56-001 Plasma Analyte A (ug/L) PANALYTA 24 h 24 H PLASMA 3621 ug/L
8 STD1-56-001 Urine Analyte A (ug/L) UANALYTA -4 0 h -4 H to Predose URINE 0 ug/L
9 STD1-56-001 Urine Analyte A (ug/L) UANALYTA 0 4 h 0 to 4 H URINE 34.5 ug/L
10 STD1-56-001 Urine Analyte A (ug/L) UANALYTA 4 8 h 4 to 8 H URINE 84.2 ug/L
11 STD1-56-001 Urine Analyte A (ug/L) UANALYTA 8 12 h 8 to 12 H URINE 65.1 ug/L
12 STD1-56-001 Urine Analyte A (ug/L) UANALYTA 12 24 h 12 to 24 H URINE 12.5 ug/L
13 STD1-56-001 Plasma Analyte B (ug/L) PANALYTB 0 h Predose PLASMA 0 ug/L
14 STD1-56-001 Plasma Analyte B (ug/L) PANALYTB 0.5 h 0.5 H PLASMA 98.1 ug/L
15 STD1-56-001 Plasma Analyte B (ug/L) PANALYTB 2 h 2H PLASMA 118.3 ug/L
16 STD1-56-001 Plasma Analyte B (ug/L) PANALYTB 4 h 4H PLASMA 120.9 ug/L
17 STD1-56-001 Plasma Analyte B (ug/L) PANALYTB 8 h 8H PLASMA 87.4 ug/L

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Duplicated Records for Analysis

Example 1: Duplicated Record for Analysis
This example shows how to handle a specific case that can often occur when doing NCA: when 1 record needs to be used in 2 separate ways. This can occur if
the last sample for 1 period (or visit) also doubles as the pre-dose sample for the next period (or visit) for the same subject. In this example, baseline values are
determined for each analysis visit. The record that will be used in 2 ways (as the 24 hours post-dose record for the DAY 1 analysis visit and as the pre-dose
baseline record for the DAY 2 analysis visit) has been duplicated (rows 8-9). The nominal times, actual times, and visit variables have all been altered for this
record and the variable DTYPE filled in. Note that the PCSEQ number for the duplicated record is repeated. BASETYPE is needed here because baseline is
flagged in each period and needed for analysis. Additionally, BASETYPE is populated to show the specific baseline type associated with each row. Similarly, the
dose (PCRFTDTM) associated with row 8 is not the same as that associated with row 9 as the calculation of actual time from reference is determined by the
associated baseline dose.
adnca.xpt
Row USUBJID PCRFTDTM ADTM ARRLT NRRLT MRRLT RRLTU ATPTREF ATPT AVAL PCSTRESU ABLFL BASE BASETYPE DTYPE CHG PCSEQ
STD1-56- 2017-04- 2017-04- DAY 1
1 -0.083 0 0 h DAY 1 Predose 0 ug/L Y 0 0 1
001 03T08:10 03T08:05 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
2 0.5167 0.5 0.5167 h DAY 1 0.5 H 383 ug/L 0 383 2
001 03T08:10 03T08:41 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
3 1 1 1 h DAY 1 1H 533 ug/L 0 533 3
001 03T08:10 03T09:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
4 2 2 2 h DAY 1 2H 455 ug/L 0 455 4
001 03T08:10 03T10:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
5 4 4 4 h DAY 1 4H 443 ug/L 0 443 5
001 03T08:10 03T12:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
6 8.083 8 8.083 h DAY 1 8H 356 ug/L 0 356 6
001 03T08:10 03T16:15 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
7 12 12 12 h DAY 1 12 H 320 ug/L 0 320 7
001 03T08:10 03T20:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 1
8 23.917 24 23.917 h DAY 1 24 H 190 ug/L 0 190 8
001 03T08:10 04T08:05 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
9 -0.083 0 0 h DAY 2 Predose 190 ug/L Y 190 COPY 0 8
001 04T08:10 04T08:05 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
10 0.5 0.5 0.5 h DAY 2 0.5 H 475 ug/L 190 285 9
001 04T08:10 04T08:40 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
11 1 1 1 h DAY 2 1H 510 ug/L 190 320 10
001 04T08:10 04T09:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
12 2 2 2 h DAY 2 2H 628 ug/L 190 438 11
001 04T08:10 04T10:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
13 4.25 4 4.25 h DAY 2 4H 532 ug/L 190 342 12
001 04T08:10 04T12:25 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
14 8 8 8 h DAY 2 8H 487 ug/L 190 297 13
001 04T08:10 04T16:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
15 12 12 12 h DAY 2 12 H 332 ug/L 190 142 14
001 04T08:10 04T20:10 BASELINE
STD1-56- 2017-04- 2017-04- DAY 2
16 25 24 25 h DAY 2 24 H 200 ug/L 190 10 15
001 04T08:10 05T09:10 BASELINE

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6 Appendices
Appendix A: ADaM ADNCA Standards Development Team

Name Institution/Organization
Lucius Reinbolt (Team Lead) Navitas Data Sciences
Cathy Bezek Astellas
Cedric Davister EMD Serono
Nate Freimark The Griesser Group
Steve Kirby Reata Pharma
Kristie Kooken Revance Therapeutics
Liz Macdonald Nuventra Pharma Sciences
Katherine Ostbye SCHARP
Jessica Purkis Amgen
David Radtke Eli Lilly
Igor Rubets Certara
Susanne Sardella Cognigen Corp
Peter Schaefer VCA-Plus
Nalin Tikoo Genentech
Lacey Wallace Audentes Therapeutics, Inc.

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Appendix B: Glossary and Abbreviations

The following abbreviations and terms are used in this document. Additional definitions can be found in the CDISC
Glossary (available at https://www.cdisc.org/standards/glossary).

ADaM Analysis Data Model

ADaMIG ADaM Implementation Guide
ADNCA ADaM NCA (dataset)
ADSL (ADaM) Subject-Level Analysis (dataset)
Analysis-ready A dataset that contains all of the variables needed for the specific analysis, so that actual statistical test
can be performed without first having to manipulate data
BDS (ADaM) Basic Data Structure
BMI Body mass index
CDISC Clinical Data Interchange Standards Consortium
CSR Clinical study report
Dataset A collection of structured data in a single file
Domain A collection of data points related by a common topic, such as adverse events or demographics
NCA Non-compartmental analysis
NSV Non-standard variable
PD Pharmacodynamics
PK Pharmacokinetics; the study of the effect of the body on a drug
OCCDS (ADaM) Structure for Occurrence Data
Occurrence analysis The counting of subjects with a given record or term. This often includes a structured hierarchy of
dictionary coding categories.
Producer The originator/sender/owner/sponsor of the data.
SAP Statistical analysis plan
SDTM Study Data Tabulation Model
SDTMIG Study Data Tabulation Model Implementation Guide

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Appendix C: Representations and Warranties, Limitations of

Liability, and Disclaimers
CDISC Patent Disclaimers
It is possible that implementation of and compliance with this standard may require use of subject matter covered by
patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any
claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be
responsible for identifying patent claims for which a license may be required in order to implement this standard or
for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its
attention.

Representations and Warranties

“CDISC grants open public use of this User Guide (or Final Standards) under CDISC’s copyright.”

Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time
of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it
holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in
which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the
grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft
Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional
restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such
Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in
source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of
the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in
Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or
any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in
part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the
same to the CDISC President who shall promptly notify all Participants.

No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED

UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS
AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT
STANDARDS, ARE PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS,
IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC
PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY
WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR
INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL,
FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION.

Limitation of Liability
IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED
TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC
MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF
USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER
UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS
POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE
OF THE POSSIBILITY OF SUCH DAMAGES.

Note: The CDISC Intellectual Property Policy can be found at

http://www.cdisc.org/system/files/all/article/application/pdf/cdisc_20ip_20policy_final.pdf

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