Table of Contents

 TOC \o "1-4" \h \z \u Table of Contents.. PAGEREF _Toc176780128 \h 1

1      Dataset Definition Metadata.. PAGEREF _Toc176780129 \h 4

2      Value-Level Metadata.. PAGEREF _Toc176780130 \h 9

2.1       Special-Purpose Domains. PAGEREF _Toc176780131 \h 9

2.1.1        Demographics – DM... PAGEREF _Toc176780132 \h 9

2.1.2        Comments – CO.. PAGEREF _Toc176780133 \h 11

2.1.2.1        Comment Identifier Variables. PAGEREF _Toc176780134 \h 12

2.2       Interventions. PAGEREF _Toc176780135 \h 14

2.2.1        Concomitant Medications – CM... PAGEREF _Toc176780136 \h 14

2.2.1.1        Prior and Concurrent Therapy Categories. PAGEREF _Toc176780137 \h 16

2.2.2        Exposure – EX.. PAGEREF _Toc176780138 \h 17

2.2.3        Substance Use – SU.. PAGEREF _Toc176780139 \h 19

2.3       Event PAGEREF _Toc176780140 \h 20

2.3.1        Adverse Events – AE. PAGEREF _Toc176780141 \h 20

2.3.2        Disposition – DS. PAGEREF _Toc176780142 \h 23

2.3.2.1        Disposition Events. PAGEREF _Toc176780143 \h 24

2.3.3        Medical History – MH.. PAGEREF _Toc176780144 \h 25

2.3.3.1        Prognostic Factors and Medical History Body systems. PAGEREF _Toc176780145 \h 27

2.3.4        Infusion Interruption – II PAGEREF _Toc176780146 \h 29

2.3.5        Death Report – DD.. PAGEREF _Toc176780147 \h 31

2.3.5.1        Survival Data Categories. PAGEREF _Toc176780148 \h 32

2.3.6        Hospitalization – HO.. PAGEREF _Toc176780149 \h 33

2.3.7        Thrombotic/Vascular Event – TH.. PAGEREF _Toc176780150 \h 34

2.4       Finding. PAGEREF _Toc176780151 \h 35

2.4.1        Pregnancy Test Results – PG.. PAGEREF _Toc176780152 \h 35

2.4.2        ECG Test Results – EG.. PAGEREF _Toc176780153 \h 36

2.4.3        Inclusion/Exclusion Exceptions – IE. PAGEREF _Toc176780154 \h 37

2.4.4        Laboratory Tests – LB.. PAGEREF _Toc176780155 \h 38

2.4.4.1        Lab Parameters and Units. PAGEREF _Toc176780156 \h 41

2.4.5        PK Concentration – PC.. PAGEREF _Toc176780157 \h 43

2.4.5.1        PK Sampling Visits and Time Points. PAGEREF _Toc176780158 \h 45

2.4.6        Anti–DRUG-B Antibody – HA.. PAGEREF _Toc176780159 \h 46

2.4.6.1        HAHA Sampling Visits and Time Points. PAGEREF _Toc176780160 \h 48

2.4.7        Physical Examination – PE. PAGEREF _Toc176780161 \h 49

2.4.7.1        Physical Examination Body Systems. PAGEREF _Toc176780162 \h 50

2.4.8        Performance Status – PS. PAGEREF _Toc176780163 \h 51

2.4.9        Subject Characteristics – SC.. PAGEREF _Toc176780164 \h 52

2.4.10      Vital Signs – VS. PAGEREF _Toc176780165 \h 53

2.4.10.1      Vital Signs Parameters and Units. PAGEREF _Toc176780166 \h 55

2.4.10.2      Vital Signs Visits and Time Points. PAGEREF _Toc176780167 \h 56

2.4.11      Radiographic Report – RG.. PAGEREF _Toc176780168 \h 57

2.4.12      Tumor Measurements – LS. PAGEREF _Toc176780169 \h 59

2.4.12.1      Target and Non-target Lesion Result Categories. PAGEREF _Toc176780170 \h 61

2.4.13      Disease Response – DR.. PAGEREF _Toc176780171 \h 62

2.5       Trial Design Domains. PAGEREF _Toc176780172 \h 64

2.5.1        Definition and Mapping of Variables ARM, ELEMENT, TAETORD, EPOCH, VISIT, and VISTNUM... PAGEREF _Toc176780173 \h 64

2.5.2        Trial Elements – TE. PAGEREF _Toc176780174 \h 67

2.5.3        Trial Arms – TA.. PAGEREF _Toc176780175 \h 68

2.5.4        Trial Visits – TV.. PAGEREF _Toc176780176 \h 69

2.5.5        Subject Elements – SE. PAGEREF _Toc176780177 \h 70

2.5.6        Subject Visit – SV.. PAGEREF _Toc176780178 \h 71

2.5.7        Trial Inclusion/Exclusion Criteria – TI PAGEREF _Toc176780179 \h 72

2.5.8        Trial Summary – TS. PAGEREF _Toc176780180 \h 73

2.6       Special-Purpose Relationship Datasets. PAGEREF _Toc176780181 \h 74

2.6.1        Related Records – RELREC.. PAGEREF _Toc176780182 \h 74

2.6.1.1        Related AE and CM records. PAGEREF _Toc176780183 \h 74

2.6.2        Supplemental Qualifiers – SUPPQUAL. PAGEREF _Toc176780184 \h 75

2.6.2.1        Supplemental Qualifier Variables. PAGEREF _Toc176780185 \h 76

 


 

1          Dataset Definition Metadata

 

Dataset

Description

Location

Structure

Purpose

Key Variables

Comment

DM

Demographics

DM.XPT

One record per subject

Tabulation

STUDYID, USUBJID

 

CO

Comments

CO.XPT

One record per comment per subject

Tabulation

STUDYID, USUBJID, COSEQ

 

CM

Concomitant Medications

CM.XPT

One record per medication intervention episode per subject

Tabulation

STUDYID, USUBJID, CMTRT, CMSTDTC

All prior surgeries, medication, and procedures from history;
All concurrent therapies on MH, AE, CM and dosing CRF pages

EX

Exposure

EX.XPT

One record per infusion per subject

Tabulation

STUDYID, USUBJID, EXTRT, EXSTDTC

 

SU

Substance Use

SU.XPT

One record per substance type per subject

Tabulation

STUDYID, USUBJID, SUTRT

 

AE

Adverse Events

AE.XPT

One record per event per subject

Tabulation

STUDYID, USUBJID, AETERM, AESTDTC

 

DS

Disposition

DS.XPT

One record per disposition status or protocol milestone per subject

Tabulation

STUDYID, USUBJID, DSTERM, DSDTC

Consent; I/E exemption Y/N;

MH

Medical History

MH.XPT

One record per medical history event per subject

Tabulation

STUDYID, USUBJID, MHTERM

 

II

Infusion Interruption

II.XPT

One record per infusion per subject

Tabulation

STUDYID, USUBJID, IITERM, IISEQ

 

DD

Death Report

DD.XPT

One record per contact/death date per subject

Tabulation

STUDYID, USUBJID, DDTERM, DDDTC, DDSEQ

Death or follow-up contact

HO

Hospitalization

HO.XPT

One record per event per subject

Tabulation

STUDYID, USUBJID, HOTERM, HOSEQ

 

PG

Pregnancy Test

PG.XPT

One record per pregnancy test result per subject

Tabulation

STUDYID, USUBJID, PGTESTCD,  PGSEQ

 

EG

ECG

EG.XPT

One record per ECG measurement per subject

Tabulation

STUDYID, USUBJID, VISITNUM, EGTESTCD,  EGSEQ

 

IE

Inclusion/Exclusion Exceptions

IE.XPT

One record per I/E criteria not met per subject

Tabulation

STUDYID, USUBJID, IETESTCD

Smoking History

LB

Laboratory Tests

LB.XPT

One record per lab test per subject

Tabulation

STUDYID, USUBJID, VISITNUM, LBTESTCD

 

PC

PK Concentration

PC.XPT

One record per PK sampling time point per subject

Tabulation

STUDYID, USUBJID, VISITNUM, PCTPTNUM, PCTESTCD

 

PP

PK Parameters

PP.XPT

One record per PK parameter per subject

Tabulation

STUDYID, USUBJID, PPTESTCD

 

HA

Anti–DRUG-B

Antibody

HA.XPT

One record per HAHA sampling time point per subject

Tabulation

STUDYID, USUBJID, VISITNUM, HATPTNUM, HATESTCD

 

PE

Physical Exam

PE.XPT

One record per subject or body system or body system finding

Tabulation

STUDYID, USUBJID, VISITNUM, PETESTCD, PESEQ

 

PS

Performance Status

PS.XPT

One record per subject

Tabulation

STUDYID, USUBJID, VISITNUM, PSTESTCD, PSSEQ

 

SC

Subject Characteristics

SC.XPT

One record per subject Characteristic

Tabulation

STUDYID, USUBJID, SCTESTCD, SCSEQ

 

VS

Vital Signs

VS.XPT

One record per vital sign per measurement per subject

Tabulation

STUDYID, USUBJID, VISITNUM, VSTPTNUM, VSTESTCD, VSSEQ

 

RG

Radiographic Report

RR.XPT

One record per radiographic exam per subject

Tabulation

STUDYID, USUBJID, VISITNUM, RGTESTCD, RGSEQ

 

LS

Tumor Measurements

LS.XPT

One record per tumor measurement/description per subject, Tabulation

Tabulation

STUDYID, USUBJID, VISITNUM, LSTESTCD, LSSEQ

 

DR

Disease Response

DR.XPT

One record per response assessment type per evaluator per subject, Tabulation

Tabulation

STUDYID, USUBJID, VISITNUM, DRTESTCD, DRSEQ

 

TE

Trial Elements

TE.XPT

One record per element

Tabulation

STUDYID, ETCD

 

TA

Trial Arms

TA.XPT

One record per element per arm

Tabulation

STUDYID, ARMCD, ETCD

 

TV

Trial Visits

TV.XPT

One record per visit per arm

Tabulation

STUDYID, VISITNUM, ARMCD

 

SE

Subject Elements

SE.XPT

One record per actual element per subject

Tabulation

STUDYID, USUBJID; ETCD

 

SV

Subject Visits

SV.XPT

One record per subject per actual visit

Tabulation

STUDYID, USUBJID, VISITNUM

 

TI

Trial Inclusion/Exclusion Criteria

TI.XPT

One record per I/E criterion

Tabulation

STUDYID, IETESTCD

 

TS

Trial Summary

TI.XPT

One record per trial summary parameter

Tabulation

STUDYID, TSTESTCD, TSSEQ

 

RELREC

Related Records

RELREC.XPT

One record per relationship

Tabulation

STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID

 

SUPPQUAL

Supplemental Qualifiers

SUPPQUAL.XPT

One record per qualifier value

Tabulation

STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM

 


 

2           Value-Level Metadata

2.1         Special-Purpose Domains

2.1.1          Demographics – DM

DM.xpt, Demographics – One record per subject, tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

DM, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

SUBJID

Subject Identifier for the Study

Char

$4

CRF

Topic

Patient number in CRF

RFSTDTC

Subject Reference Start Date/Time

Char

yyyy-mm-dd, $10

Sponsor Defined

Timing

Date of first treatment dose
ISO 8601

RFENDTC

Subject Reference End Date/Time

Char

yyyy-mm-dd, $10

Sponsor Defined

Timing

Date of last treatment dose
ISO 8601

SITEID

Study Site Identifier

Char

$3

CRF

Record Qualifier

Unique site number within the submission

INVNAM

Investigator Name

Char

Last name, first initial, $20

Derived

Synonym Qualifier

 

COUNTRY

Country

Char

US, $2

Derived

Result Qualifier

ISO 3166

BRTHDTC

Date/Time of Birth

Char

yyyy-mm-dd, $10

CRF

Result Qualifier

ISO 8601

AGE

Age in AGEU at Reference Date/Time

Num

N5.1

Derived

Result Qualifier

(RFSTDTC - BRTHDTC + 1)/365.25

AGEU

Age Units

Char

years, $5

Derived

Variable Qualifier

 

SEX

Sex

Char

M, F, U, $1

CRF

Result Qualifier

M, F, U for Male, Female, Unknown

RACE

Race

Char

$8

CRF

Result Qualifier

WHITE (for Caucasian), BLACK, ASIAN, HISPANIC, OTHER

ARMCD

Planned Arm Code

Char

COHORT 1
…

COHORT n, $8

CRF/ Derived

Result Qualifier

 

ARM

Description of Planned Arm

Char

$20

CRF/ Derived

Synonym Qualifier

Dose Level 2.0 mg/kg, 4.0 mg/kg, etc.

SUBJINIT

Subject Initials

Char

$3

CRF

 

SC domain

PROTVER

Protocol Version

Char

$20

CRF

 

SUPPQUAL domain

RACEOTH

Race Other Specify

Char

$20

CRF

 

SUPPQUAL domain

ICDTC

Informed Consent Date/Time

Char

yyyy-mm-dd, $10

CRF

 

DS domain variable DSDTC with DSTERM of ‘INFORMED CONSENT OBTAINED’.


 

2.1.2          Comments – CO

CO.xpt, Comments – One record per comment per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

CO, $2

Derived

Identifier

 

RDOMAIN

Related Domain Abbreviation

Char

$2

Derived

Identifier

Refer to Section 2.1.2.1.

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

COSEQ

Sequence Number

Num

N3.0

Derived

Identifier

 

IDVAR

Identifier Variable Name

Char

$8

Derived

Identifier

Refer to Section 2.1.2.1.

IDVARVAL

Identifier Variable

Char

$50

Derived

Identifier

Refer to Section 2.1.2.1.

COREF

Comment Reference

Char

$50

CRF

Record Qualifier

CRF page number, page name, or both. Refer to Section 2.1.2.1.

CODTC

Date/Time of Comment

Char

yyyy-mm-dd

CRF

Timing

A date or null, ISO 8601

COVAL

Comment

Char

$200

CRF

Result Qualifier

Cannot be Null, for the first 200 characters of comment

COVAL1

Comment1

Char

$200

CRF

Result Qualifier

Next 200 characters or null

…

 

 

 

 

 

 

COVALn

Commentn

Char

$200

CRF

Result Qualifier

Last up to 200 characters or null

COEVAL

Evaluator

Char

$50

Derived

Record Qualifier

PRINCIPAL INVESTIGATOR
CLINICAL COORDINATOR
INDEPENDENT REVIEW COMMITTEE
ADJUDICATION COMMITTEE
STATISTICIAN
DATABASE ADMINISTRATOR
etc.


 

2.1.2.1         Comment Identifier Variables

RDOMAIN

IDVAR

IDVARVAL

COREF

Note

DS

DSTERM

INCL/EXEL EXEMPTION GRANTED

CRF PAGE 1

 

AE

AETERM

(Adverse event verbatim)

CRF PAGE 200.___

COREF needs 2nd part of actual AE page number.

CM

CMSPID

CONCURRENT THERAPY PAGE

CRF PAGE 400.___

COREF needs 2nd part of actual CM page number.

EG

EGORRES

ABNORMAL-CLINICALLY SIGNIFICANT

CRF PAGE 4

 

EG

EGORRES

ABNORMAL-NOT CLINICALLY SIGNIFICANT

CRF PAGE 4

 

PE

PEORRES

ABNORMAL

CRF PAGE 9, etc.

 

II

IIREL

ADVERSE EVENT

CRF PAGE 18, etc.

 

II

IIREL

OTHER

CRF PAGE 18, etc.

 

RG

RGMETHOD

OTHER

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

RG

RGORRES

ABNORMAL-CLINICALLY SIGNIFICANT

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

RG

RGORRES

ABNORMAL-NOT CLINICALLY SIGNIFICANT

CRF PAGE 13 PART 1,
CRF PAGE 13 PART 2,
etc.

For radiographic report page, top part is referred to as PART 1, and the bottom part for additional radiographic test is referred to as PART 2.

LS

VISIT

BASELINE
END OF TREATMENT CYCLE 1
…
END OF THERAPY

CRF PAGE 26
CRF PAGE 62

CRF PAGE 95

 

DS

DSTERM

ADVERSE EVENT

CRF PAGE 87

 

DS

DSTERM

WITHDRAWAL OF CONSENT

CRF PAGE 87

REASON: (verbatim)

DS

DSTERM

OTHER

CRF PAGE 87

 

HO

HORELNST

ADVERSE EVENT

CRF PAGE 100.___

COREF needs 2nd part of actual HO page number.

HO

HORELNST

OTHER

CRF PAGE 100.___

COREF needs 2nd part of actual HO page number.

DD

DDREL

ADVERSE EVENT

CRF PAGE 102

 


 

2.2         Interventions

2.2.1          Concomitant Medications – CM

CM.xpt, Concomitant Meds – One record per medication intervention episode per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

CM, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

CMSEQ

Sequence Number

Num

N3

Derived

Identifier

In the order of start date or order of records on the Medical History page

CMGRPID

Group ID

Char

$50

Sponsor Defined

Identifier

Refer to Section 2.2.1.1.

CMSPID

Sponsor ID

Char

CRF PAGE __ LINE __, $50

Sponsor Defined

Record Qualifier

Printed or DM assigned line number.

CMOCCUR

CM Occurrence

Char

Y, N, Null, $1

Sponsor Defined

Result Qualifier

Refer to Section 2.2.1.1.

CMTRT

Reported Name of Drug, Med, or Therapy

Char

$200

CRF

Topic

Refer to Section 2.2.1.1.

CMMODIFY

Modified Reported Name

Char

$200

Sponsor Defined

Synonym Qualifier

 

CMDECOD

Standardized Medication Name

Char

$50

Derived

Synonym Qualifier

WHO drug version ???

CMCLAS

Medication Class

Char

$50

Derived

Variable Qualifier

Null, if WHO Drug used to code CM

CMCAT

Category for Medication

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.2.1.1.

To be determined by Clinical

CMSCAT

Subcategory for Medication

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.2.1.1.

CMINDC

Indication

Char

$50

CRF

Record Qualifier

‘Prophylaxis - ______’, if CM page INDICATION prophylaxis box ticked

CMDOSTXT

Dose Description

Char

$50

CRF

Result Qualifier

Premedication DOSE or null

CMDOSREG

Intended Dose Regimen

Char

$200

CRF

Result Qualifier

Central VAD History ANTICOAGULANT USE – NA or
ANTICOAGULANT USE ____

or null

CMSTDTC

Start Date/Time of Medication

Char

yyyy-mm-dd,
yyyy-mm-ddThh:mm,
Null, $16

CRF

Timing

Use study treatment dosing date, if record from dosing page; ISO 8601

CMENDTC

End Date/Time of Medication

Char

yyyy-mm-dd, Null, $10

CRF

Timing

For transfusion, enter date of last transfusion; ISO 8601

CMSTRF

Start Relative to Reference Period

Char

BEFORE, DURING, AFTER, Null, $6

Derived

Timing

Compare CMSTDTC to RFSTDTC in DM domain

CMENRF

End Relative to Reference Period

Char

BEFORE, DURING, AFTER, Null, $6

Derived

Timing

Compare CMENDTC to RFENDTC in DM domain

= AFTER, if CM page DATE DISCONTIUNED if continuing box ticked, or if AE CRF page DATE COMPLETED if continuing box ticked


 

2.2.1.1         Prior and Concurrent Therapy Categories

CMGRPID

CMSPID

CMCAT

CMSCAT

CMTRT

CMOCCUR

TRANSFUSION HISTORY

CRF PAGE 5

TRANSFUSION

 

PACKED RED BLOOD CELLS
PLATELETS
OTHER (- verbatim)

N, Null

CENTRAL VENOUS ACCESS DEVICE HISTORY

CRF PAGE 5

PROCEDURE

CENTRAL VENOUS ACCESS DEVICE

HICKMAN
GROSHONG
PORT
PICC
OTHER (- verbatim)

N, Null

MEDICAL HISTORY PAGE

CRF PAGE 7.__

MEDICATION/ TRANSFUSION/ PROCEDURE

 

(Verbatim)

Y (if MEDICATED box ticked),
Null

PRIOR DISEASE RELATED THERAPY

CRF PAGE 8

MEDICATION

CHEMOTHERAPY
HORMONAL
IMMUNOTHERAPY
RADIOTHERAPY
INVESTIGATIONAL AGENT
OTHER

(Verbatim)

N, Null

PRIOR DISEASE RELATED SURGERY

CRF PAGE 8

SURGERY

 

(Verbatim)

N, Null

PREMEDICATION ON TREATMENT ADMINISTRATION PAGE

CRF PAGE 18, etc.

MEDICATION

 

(Verbatim)

N, Null

ADVERSE EVENT PAGE

CRF PAGE 200.__(.___)

MEDICATION/ TRANSFUSION/ PROCEDURE

 

(Verbatim)

Null

CONCURRENT THERAPY PAGE

CRF PAGE 400.__

MEDICATION/ TRANSFUSION/ PROCEDURE

 

(Verbatim)

N, Null


 

2.2.2          Exposure – EX

EX.xpt, Exposure – One record per infusion per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

EX, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

EXOCCUR

Dosing Occurrence

Char

Y, N, $1

CRF

Result Qualifier

Y, if Administered box is ticked; N, if Held or Not Done box is ticked

EXSTAT

Dosing Status

Char

NOT DONE, Null $8

CRF

Result Qualifier

Not Done, if Not Done box is ticked

EXREASND

Reason Dosing Not Done

Char

$200

CRF

Record Qualifier

‘Held - _____’ if Held box ticked and reason given; ‘Not Done - _______’, if Not Done box ticked and reason given

EXSEQ

Sequence Number

Num

N3

Derived

Identifier

In the order of infusion date

EXGRPID

Group ID

Char

PK SAMPLING
CYCLE 1
…
CYCLE n, $50

Sponsor Defined

Identifier

 

EXSPID

Sponsor Reference Number

Char

CRF PAGE __, $20

CRF

Identifier

CRF page number

EXTRT

Name of Actual Treatment

Char

DRUG-B, $10

CRF

Topic

 

EXDOSE

Dose per Administration

Num

N8.2

CRF

Result Qualifier

Total Dose Administered (mg)

EXDOSTXT

Dose Description

Char

$12

CRF

Result Qualifier

e.g. 2.0 mg/kg

EXDOSU

Dose Units

Char

mg, $2

CRF

Variable Qualifier

 

EXDOSFRM

Dose Form

Char

INJECTABLE

Sponsor Defined

Result Qualifier

 

EXDOSTOT

Total Daily Dose Using EXDOSU

Num

N8.2

Derived

Result Qualifier

= EXDOSE

EXROUTE

Route of Administration

Char

IV – INFUSION, $20

Sponsor Defined

Result Qualifier

 

EXLOT

Lot Number

Char

$20

CRF

Record Qualifier

 

EXSTDTC

Start Date/Time of Treatment

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

EXENDTC

End Date/Time of Treatment

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

VISIT

Visit Name

Char

$50

CRF

Timing

Refer to Section 2.5.1.

VISITNUM

Visit Number

Num

N6.2

Derived

Timing

Refer to Section 2.5.1.


 

2.2.3          Substance Use – SU

SU.xpt, Substance USE – One record per substance type per visit per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

SU, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

SUOCCUR

SU Occurrence

Char

Y, N, Null $1

CRF

Result Qualifier

N, Never Smoked box ticked; Y, Current Smoker or Past Smoker box ticked

SUSEQ

Sequence Number

Num

1

Derived

Identifier

 

SUSPID

Sponsor Reference Number

Char

SMOKING HISTORY, $20

Sponsor Defined

Record Qualifier

 

SUTRT

Name of Substance

Char

TOBACCO, $10

CRF

Topic

 

SUDOSE

Substance Use Consumption

Num

N4.1

CRF

Result Qualifier

Number of packs per day

SUDOSTXT

Substance Use Consumption Text

Char

NEVER SMOKED-NOT EXPOSED TO SECOND-HAND SMOKE
NEVER SMOKED-EXPOSED TO SECOND-HAND SMOKE
CURRENT SMOKER
PAST SMOKER
$50

CRF

Result Qualifier

Smoking history and second-hand smoking questions combined

SUDOSU

Consumption Units

Char

packs/day, $9

CRF

Variable Qualifier

 

SUENDTC

End Date/Time of Substance Use

Char

yyyy, $4

CRF

Timing

year, ISO 8601

SUDUR

Duration of Substance Use

Char

$10

CRF

Timing

e.g. 12Y3M, 12.5Y, ISO 8601


 

2.3         Event

2.3.1          Adverse Events – AE

AE.xpt, Adverse Events –One record per event per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

AE, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

AESEQ

Sequence Number

Num

N3.0

Derived

Identifier

In the order of

AEGRPID

Group ID

Char

 

Sponsor Defined

Identifier

TBD

AEREFID

Reference ID

Char

SAE NUMBER ________, $30

Sponsor Defined

Identifier

e.g. SAE NUMBER 123.456. The SAE number is from SAE report

AESPID

Sponsor ID

Char

CRF PAGE _______, $30

Sponsor Defined

Identifier

e.g. CRF PAGE 200.1

AETERM

Reported Term for the Adverse Event

Char

$200

CRF

Topic

Original verbatim

AEMODIFY

Modified Reported Term

Char

$200

Sponsor Defined

Synonym Qualifier

Modified verbatim

AEDECOD

Dictionary-Derived Term

Char

$50

Derived

Synonym Qualifier

MedDRA Preferred Term
MedDRA version: 7.1

AEBODSYS

Body System or Organ Class

Char

$50

Derived

Result Qualifier

MedDRA SOC

AECAT

Category for Adverse Event

Char

$50

Sponsor Defined

Grouping Qualifier

TBD, e.g. INFUSION REACTION

AESCAT

Subcategory for Adverse Event

Char

$50

Sponsor Defined

Grouping Qualifier

TBD

AESER

Serious Event

Char

Y, N, $1

CRF

Record Qualifier

 

AESTDTC

Start Date/Time of Adverse Event

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

AEENDTC

End Date/Time of Adverse Event

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

AEENRF

End Relative to Reference Period

Char

BEFORE, DURING, AFTER, null, $6

Derived

Timing

TBD

AETOXGR

Standard Toxicity Grade

Char

1, 2, 3, 4, 5, $1

CRF

Record Qualifier

CTCAE v3.0

AEREL

Causality

Char

UNRELATED
POSSIBLE
PROBABLE
DEFINITE, $9*

CRF

Result Qualifier

 

AEPATT

Pattern of Event

Char

INTERMITTENT, null, $12

CRF

Record Qualifier

Null for this study

AEACN

Action Taken with Study Treatment

Char

NONE
MODIFIED
HELD
DISCONTINUED
N/A, $12

CRF

Record Qualifier

 

AECONTRT

Concomitant or Additional Trtmnt Given (Corrective Therapy)

Char

Y, N, $1

CRF

Record Qualifier

 

AEOUT

Outcome of Adverse Event

Char

RESOLVED
STABILIZED
ONGOING
DIED
CHANGE IN GRADE, $15

CRF

Result Qualifier

 

AESCONG

Congenital Anomaly or Birth Defect

Char

Y, N, or Null

CRF

Result Qualifier

 

AESDISAB

Persist or Signif Disability/Incapacity

Char

Y, N, or Null

CRF

Result Qualifier

 

AESDTH

Results in Death

Char

Y, N, or Null

CRF

Result Qualifier

 

AESHOSP

Requires or Prolongs Hospitalization

Char

Y, N, or Null

CRF

Result Qualifier

 

AESLIFE

Is Life Threatening

Char

Y, N, or Null

CRF

Result Qualifier

 

AESMIE

Other Medically Important Serious Event

Char

Y, N, or Null

CRF

Result Qualifier

 

AESEV

Severity/DLT

Char

DOSE LIMITING TOXICITY, Null, $22

Derived

Record Qualifier

Use AESEV or AESCAT to capture DLT?


 

2.3.2          Disposition – DS

DS.xpt, Disposition – One record per disposition status or protocol milestone per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

DS, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

DSSEQ

Sequence Number

Num

N2.0

Derived

Identifier

In the order of dates.

DSTERM

Disposition Term

Char

$200

CRF

Topic

Refer to Section 2.3.2.1.

DSDECOD

Controlled Terminology for DSTERM

Char

$200

CRF

Synonym Qualifier

=DSTERM

DSCAT

Category for Disposition Event

Char

 

 

Grouping Qualifier

Refer to Section 2.3.2.1.

DSSCAT

Subcategory for Disposition Event

Char

 

 

Grouping Qualifier

Refer to Section 2.3.2.1.

DSDTC

Date/Time of Collection

Char

yyyy-mm-dd, $10

CRF

Timing

Refer to Section 2.3.2.1.  ISO 8601


 

2.3.2.1         Disposition Events

DSCAT

DSSCAT

DSTERM

NOTE

PROTOCOL MILESTONE

INFORMED CONSENT

INFORMED CONSENT OBTAINED

DSDTC = (Date consent form signed)

DISPOSITION EVENT

ELIGIBILITY

INCL/EXCL EXEMPTION GRANTED

INCL/EXCL EXEMPTION NOT GRANTED

DSDTC = (Date exemption granted)

DISPOSITION EVENT

STUDY THERAPY DISCONTINUATION

COMPLETED TREATMENT (CYCLE 1) AND DID NOT GO ON TO ADDITIONAL CYCLES

DISEASE PROGRESSION

CLINICAL DETERIORATION WITHOUT DOCUMENTED RADIOLOGICAL PROGRESSION

ADVERSE EVENT

DEATH

WITHDRAWAL OF CONSENT

LOST TO FOLLOW-UP

SUBJECT NON-COMPLIANCE WITH PROTOCOL

PREGNANCY/BREASTFEEDING

NEVER TREATED WITH STUDY MEDICATION

OTHER

DSDTC = (Date Discontinued from Study Therapy)

 

Verbatim goes to Domain CO.

 

Lost to follow-up last contact date goes to Domain DD.


 

2.3.3          Medical History – MH

MH.xpt, Medical History – One record per medical history event per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

MH, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

MHSEQ

Sequence Number

Num

N4.2

CRF

Identifier

For decimal part, use the CRF preprinted or DM assigned line number.

MHGRPID

Group ID

Char

$25

CRF

Identifier

Refer to Section 2.3.3.1.

MHSPID

Sponsor ID

Char

$4

CRF

Identifier

For MH, the pre-printed body system number.  Refer to Section 2.3.3.1.

MHCAT

Category for Medical History

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.3.3.1.

MHCAT

Category for Medical History

Char

$50

Sponsor Defined

Grouping Qualifier

Verbatim specifying other cancer type.

MHOCCUR

Medical History Occurrence

Char

Y, N, Null, $1

Sponsor Defined

Result Qualifier

 

MHSTDTC

Start Date/Time of Medical History Event

Char

yyyy-mm-dd, Null, $10

CRF

Timing

ISO 8601.  Refer to Section 2.3.3.1.

MHTERM

Reported Term for the Medical History

Char

$200

CRF

Topic

PF or MH item verbatim recorded.  Refer to Section 2.3.3.1.

MHDECOD

Dictionary-Derived Term

Char

$50

Derived

Synonym Qualifier

Null

MHBODSYS

Body System or Organ Class

Char

$50

Derived

Result Qualifier

Null

MHSEV

Medical History Event Grade

Char

$50

CRF

Result Qualifier

Refer to Section 2.3.3.1.  Null for PF

MHENRF

End Relative to Reference Period

Char

BEFORE, DURING, $6

Derived

Timing

Only when a line is recorded on MH page. If CURRENT CONDITION YES box is tick, DURING; else BEFORE.


 

2.3.3.1         Prognostic Factors and Medical History Body systems

MHSEQ

MHGRPID

MHSPID

MHCAT

MHOCCUR

Note

1.(DM assigned line number)

DIAGNOSIS – CANCER TYPE

CA01
CA02
CA03
CA04
CA05
CA06
CA07
CA08
CA09
CA10
CA11
CA12

BLADDER
BREAST
COLORECTAL
ESOPHAGEAL
HEAD AND NECK
KAPOSI’S SARCOMA (HIV RELATED)
OVARIAN
PANCREATIC
PROSTATE
RENAL
STOMACH
OTHER

Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null
Y, Null

MHTERM = HISTOLOGY (- verbatim)

MHSTDTC = (Date of initial histopathological diagnosis of cancer)

 

GRADE =
WELL DIFFERENTIATED or
MODERATELY DIFFERENTIATED or
POORLY DIFFERENTIATED/ UNDIFFERENTIATED or
UNKNOWN

2.(DM assigned line number)

PROGNOSTIC FACTOR

PF01
PF02
PF03
PF04
PF05
PF06
PF07
PF08
PF09
PF10
PF11
PF12
PF13
PF14
PF15
PF16
PF17
PF18

DEEP VEIN THROMBOSIS
PULMONARY EMBOLISM
VENOUS INSUFFICIENCY
ARTERIAL HYPERTENSION
THROMBOCYTOSIS
CEREBROVASCULAR ACCIDENT
TRANSIENT ISCHEMIC ATTACK
MYOCARDIAL INFARCTION
OTHER CARDIAC EVENT
PROLONGED HOSPITALIZATION
IMMOBILIZATION
OBESITY
TRAUMA WITHIN PAST 3 MONTHS
SURGERY IN PAST 3 MONTHS
TAMOXIFEN USE
HYPERCHOLESTEROLEMIA
DIABETES MELLITUS
LIVER DISEASE

Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N
Y, N






MHSTDTC = (Event date recorded)

MHSTDTC = (Event date recorded)
MHTERM = (Verbatim recorded)



MHTERM = (Verbatim recorded)
MHTERM = (Verbatim recorded)



MHTERM = (Verbatim recorded)

3.(preprinted line number for lines with entry only)

MEDICAL HISTORY

MH01
MH02
MH03
MH04
MH05
MH06
MH07
MH08
MH09
MH10
MH11
MH12
MH13
MH14

HEENT
RESPIRATORY
CARDIOVASCULAR
GASTROINTESTINAL
GENITOR-URINARY
MUSCULOSKELETAL
NEUROLOGICAL
ENDOCRINE/METABOLIC
HEMATOPOIETIC/LYMPHATIC
DERMATOLOGICAL
PSYCHOLOGICAL
SURGERY
ALLERGIES
OTHER

 

Only enter body systems with medical history recorded
MHTERM = (Verbatim recorded)

 

GRADE =(Verbatim in the GRADE column)


 

2.3.4          Infusion Interruption – II

II.xpt, Infusion Interruption –One record per infusion per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

DD, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

IISEQ

Sequence Number

Num

N3

Derived

Identifier

In the order of infusion date

IIGRPID

Group ID

Char

PK SAMPLING
CYCLE 1
…
CYCLE n, $50

Sponsor Defined

Identifier

 

IISPID

Sponsor ID

Char

CRF PAGE __, $20

CRF

Identifier

CRF page number

IIOCCUR

Infusion Interrupted

Char

Y, N, Null, $1

CRF

Result Qualifier

Infusion interruption?

IISTDTC

Start Date/Time of Infusion Interruption

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

IIENDTC

End Date/Time of Infusion Interruption

Char

yyyy-mm-ddThh:mm, $16

CRF

Timing

Date and time, ISO 8601

VISIT

Visit Name

Char

$50

CRF

Timing

Refer to Section 2.5.1.

VISITNUM

Visit Number

Num

N6.2

Derived

Timing

Refer to Section 2.5.1.

IITERM

Reported Term for the Event

Char

Infusion Interrupted, $25

CRF

Topic

 

IIDECOD

Dictionary-Derived Term

Char

Null, $50

Derived

Synonym Qualifier

 

IIACNOTH

Infusion Resumed

Char

RESUMED THE SAME DAY
DID NOT RESUME THE SAME DAY, $30

CRF

Record Qualifier

 

IIREL

Reason for Interruption

Char

HYPERSENSITIVITY
ADVERSE EVENT
EQUIPMENT FAILURE
OTHER, $20

CRF

Result Qualifier

Verbatim goes to CO domain.


 

2.3.5          Death Report – DD

DD.xpt, Death report –One record per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

DD, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

DDSEQ

Sequence Number

Num

N3.0

Derived

Identifier

In the order of date(s)

DDSPID

Sponsor ID

Char

$20

CRF

Identifier

CRF page number or survival survey sequence number/date.

DDOCCUR

DDTERM Occurrence

Char

Y, N, Null, $1

CRF

Result Qualifier

Died on study or within 30 days Y/N boxes. If N, null for all other variables.

DDTERM

Reported Term for the Event

Char

$200

CRF

Topic

Refer to Section 2.3.5.1.

DDDECOD

Dictionary-Derived Term

Char

$50

Derived

Synonym Qualifier

Refer to Section 2.3.5.1.

DDCAT

Category for Adverse Event

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.3.5.1.

DDSCAT

Subcategory for Adverse Event

Char

$50

Sponsor Defined

Grouping Qualifier

Refer to Section 2.3.5.1.

DDDTC

Date/Time of Death/Last Contact

Char

yyyy-mm-dd, $10

CRF

Timing

Date of death or Lost to follow-up last contact date. ISO 8601

DDRELNST

Primary Cause of Death

Char

DISEASE PROGRESSION
ADVERSE EVENT
UNKNOWN, $20

CRF

Result Qualifier

Verbatim goes to Domain CO.

DDACNOTH

Autopsy

Char

PERFORMED
NOT PERFORMED, $20

CRF

Record Qualifier

 


 

2.3.5.1         Survival Data Categories

DDCAT

DDSCAT

DDTERM

DDDECOD

DEATH

DIED ON STUDY

DIED OFF STUDY

DIED ON STUDY OR WITHIN 30 DAYS OF THE LAST DOSE OF STUDY MEDICATION

DIED AFTER 30 DAYS OF THE LAST DOSE OF STUDY MEDICATION

DEATH

DEATH

FOLLOW UP

LOST TO FOLLOW-UP

FOLLOW UP

LAST CONTACT

MOST RECENT CONTACT

CONTACT

CONTACT

Note: Texts in italic are or are not applicable in this protocol.


 

2.3.6          Hospitalization – HO

DD.xpt, Hospitalization – One record per event per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

HO, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

HOSEQ

Sequence Number

Num

N3.0

Derived

Identifier

In the order of date(s)

HOSPID

Sponsor ID

Char

$20

CRF

Identifier

CRF page number.

HOOCCUR

HOTERM Occurrence

Char

Y, N, Null, $1

CRF

Result Qualifier

Hospitalized on study or within 30 days Y/N boxes. If N, null for all other variables.

HOTERM

Reported Term for the Event

Char

HOSPITALIZED ON STUDY OR WITHIN 30 DAYS OF THE LAST DOSE OF STUDY MEDICATION, $200

CRF

Topic

 

HODECOD

Dictionary-Derived Term

Char

HOSPITALIZATION$50

Derived

Synonym Qualifier

 

HOSTDTC

Date/Time of Hospital Admission

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

HOENDTC

Date/Time of Hospital Discharge

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

HORELNST

Reason for Admission

Char

DISEASE PROGRESSION
ADVERSE EVENT
OTHER, $20*

CRF

Result Qualifier

Verbatim goes to Domain CO.

HOACNOTH

Discharge Summary Attached

Char

ATTACHED
NOT AVAILABLE, $20

CRF

Record Qualifier

 


 

2.3.7          Thrombotic/Vascular Event – TH

TH.xpt, Thrombotic/Vascular Event – One record per event per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

TV, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

THSEQ

Sequence Number

Num

N3.0

Derived

Identifier

In the order of TVSPID

THSPID

Sponsor ID

Char

$20

CRF

Identifier

CRF page number.

THOCCUR

THTERM Occurrence

Char

Y, N, Null, $1

CRF

Result Qualifier

Thrombotic/Vascular Event on study or within 30 days Y/N boxes. If N, null for all other variables.

THTERM

Reported Term for the Event

Char

THROMBOTIC/VASCULAR EVENT ON STUDY OR WITHIN 30 DAYS OF THE LAST DOSE OF STUDY MEDICATION, $200

CRF

Topic

 

THDECOD

Dictionary-Derived Term

Char

THROMBOTIC/VASCULAR EVENT, $50

Derived

Synonym Qualifier

 


 

2.4         Finding

2.4.1          Pregnancy Test Results – PG

PG.xpt, Pregnancy Test – One record per pregnancy test result per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

PG, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

PGSEQ

Sequence Number

Num

 

Derived

Identifier

In the order of date

VISIT

Visit Name

Char

$50

CRF

Timing

Refer to Section 2.5.1.

VISITNUM

Visit Number

Num

N6.2

Derived

Timing

Refer to Section 2.5.1.

PGSTAT

Pregnancy Test Status

Char

NOT DONE, Null, $8

CRF

Result Qualifier

If Not Applicable ticked

PGREASND

Reason Pregnancy Test Not Applicable

Char

$200

CRF

Record Qualifier

 

PGDTC

Date/Time of Pregnancy Test

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

PGTESTCD

Pregnancy Test Short Name

Char

PREGTEST, $8

Derived

Topic

 

PGTEST

Pregnancy Test Name

Char

SERUM BETA HCG PREGNANCY TEST, $50

CRF

Synonym Qualifier

 

PGORRES

Result or Finding in Original Units

Char

POSITIVE
NEGATIVE
Null, $40

CRF

Result Qualifier

 

PGSTRESC

Character Result/Finding in Std Format

Char

$40

Derived

Result Qualifier

= PGORRES

PGBLFL

Baseline Flag

Char

Y, $1

Derived

Record Qualifier

 

PGEVAL

Evaluator

Char

Null, $20

CRF

Record Qualifier

 


 

2.4.2          ECG Test Results – EG

EG.xpt, ECG – One record per ECG observation per time point per visit per subject, Tabulation

Variable Name
(max 8 char)

Variable Label
(max 40 char)

Type

Controlled Terms or Format

Origin

Role

Note

STUDYID

Study Identifier

Char

CP12-, $9

CRF

Identifier

Protocol Number

DOMAIN

Domain Abbreviation

Char

EG, $2

Derived

Identifier

 

USUBJID

Unique Subject Identifier

Char

STUDYID/
SITEID-SUBJID, $20

Sponsor Defined

Identifier

Unique subject ID with in the CP12 development program

EGSEQ

Sequence Number

Num

 

Derived

Identifier

In the order ECG date

VISIT

Visit Name

Char

$50

CRF

Timing

Refer to Section 2.5.1.

VISITNUM

Visit Number

Num

N6.2

Derived

Timing

Refer to Section 2.5.1.

EGDTC

Date/Time of ECG

Char

yyyy-mm-dd, $10

CRF

Timing

ISO 8601

EGTESTCD

ECG Test or Examination Short Name

Char

ECG, $3

Derived

Topic

 

EGTEST

ECG Test or Examination Name

Char

ELECTROCARDIOGRAM
$20

CRF

Synonym Qualifier

 

EGCAT

Category for ECG

Char

FINDING, $7

Derived

Grouping Qualifier

 

EGPOS

ECG Position of Subject

Char

Null, $10

Derived

Record Qualifier

 

EGORRES

Result or Finding in Original Units

Char

NORMAL
ABNORMAL-CLINICALLY SIGNIFICANT
ABNORMAL-NOT CLINICALLY SIGNIFICANT, $40

CRF

Result Qualifier

 

EGSTRESC

Character Result/Finding in Std Format

Char

$40

Derived

Result Qualifier

= EGORRES

EGBLFL

Baseline Flag

Char

Y, $1

Derived