Length/

Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study IdentChar 12 Demo STUDY
DOMAIN Domain Abb Char 2 DM
USUBJID Unique Subj Char 17 Demo

Subject
Identifier
for the
SUBJID Study Char 3 Demo PTNO

Subject
Reference
Start
Date/Tim
RFSTDTC e Char 12 ISO8601 ex

Subject
Reference
End
Date/Tim
RFENDTC e Char 12 ISO8601 ex

Date/Tim
e of first
Study
Treatmen
RFXSTDTC t Char ISO8601

Date/Tim
e of last
Study
Treatmen
RFXENDTC t Char ISO8601
SITEID Study Site 4 Demo CENTRE
Identifier Char
AGE Age num 3 Demo age

AGEU Age Units Char 6 AGEU

SEX Sex Char 1 SEX Demo sex_

RACE Race Char RACE

ARMCD Planned Char

Arm Code
ARM Description Char
of Planned
Arm
COUNTRY Country Char COUNTRY ISO3166

DMDTC Date/Time Char ISO8601 Demo VISITDT

of
Collection
DMDY Study Day Num
of
Collection
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
= "DM" Assigned Identifier Required
=concatenation (STUDY, CENTRE, PT Derived Identifier Required
CRF 2 Topic Required

=PTNO
Record Expected
Qualifier

=min(ex.exstdtc) Derived
Record Expected
Qualifier

=min(ex.exendtc) Derived
Record Expected
Qualifier

=rfstdtc
Record Expected
Qualifier

=rfendtc
=CENTRE CRF 2 Record Required
Qualifier
=non missing of age CRF 2 Record Expected
Qualifier
="YEARS" CRF 2 Variable Expected
Qualifier
=substr(sex_,1,1) CRF 2 Record Required
Qualifier
NOT SUBMITTED Record Expected
Qualifier
="VAH" Derived Record Required
Qualifier
="Valsartan Hyderochloro thiazide" Derived Synonym Required
Qualifier
="IND" PROTOCO Record Required
L Qualifier
=VISITDT CRF 2 Timing Permissibl
e

= dmdtc-rfstdtc Derived Timing Permissibl

e
 Length/
Variable Label Type Significant Digits Controlled Terms Format
STUDY ID Study Identifier Char 12
DOMAIN Domain Abbreviation Char 2 EX
USUBJID Unique Subject Identifier Char 17
EXSEQ Sequence Number num
EXTRT name of actual treatment char

EXDOSE Dose num

EXTDOSTXT Char

EXdDOSU

EXDOSFRM dose form Char

EXDOSFRQ Char
EXROUTE
EXSTDTC c ISO8601
EXENDTC
 dataset variable Programming Algorithm Origin Page number Role
admin STUDY ="CVAH631BIN01" CRF 2 Identifier
= "EX" Assigned Identifier
admin =concatenation (STUDY, CENTRE, PTNO) Derived Identifier
= chronological order of extrt Identifier
="CO-DIOVAN" or drug Topic
record
qualifier
record
admin =dose qualifier
Variable
admin =mg
record
="TABLET" qualifier
="QD"
="ORAL"
admin =min(visitdt)
=max(visitdt
 Core Notes
Required
Required
Required
Required
Required
Expected

Permissibl
e
Permissibl
e
Expected
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 Demo STUDY
DOMAIN Domain Abbreviation Char 2 DM
USUBJID Unique Subject IdentifieChar 17 Demo
DSSEQ SEQUENCE NUMBER num

Reported Term for the

dsterm Disposition Event Char Demo

Standardized
Disposition
DSDECOD Term Char Demo

DSCAT category for disposition Char Demo

EPOCH epoch char Demo

dsstdtc Demo
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
= "DS" Assigned Identifier Required
=concatenation (STUDY, CENTRE, PTNO) Derived Identifier Required
chronological order Identifier Required
topic Required

= if ^ missing ICFDT then dsterm "INFORMED

CONSENT OBTAINED" complete="Yes" then
dsterm="COMPLETED"

dsdecod=dsterm

dsterm="INFORMED CONSENT OBTAINED"

then "protocol milestone"
dsterm="COMPLETED" then
dscat="DISPOSITION EVENT" Assigned
timing permissible
dscat="protocol milestone" epoch=followup Assigned

dsterm="INFORMED CONSENT OBTAINED then

dsstdtc=icfdtc dsterm="COMPLETED" then
dsstdtc=visitdt timing expected
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY
STUDY ID Study Identifier Char 12 demo
Domain
DOMAIN Abbreviation Char 2 MH

Unique Subject
USUBJID Identifier Char 17 demo
SEQUENCE
MHSEQ NUMBER num

term of
MHTERM medical history Char demo

date/time of
history
MHDTC collection Char ISO8601 demo
medical history
MHSTDTC event Char ISO8601 demo
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required

Identifier Required
= "MH" Assigned
Identifier Required

=concatenation (STUDY, CENTRE,

PTNO) Derived
Identifier Required
chronological order
Topic Required

=if ^ missing hisdt then

"HYPERTENSION"
timing permissible

=visitdt
timing permissible
=histdt
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset
STUDY ID Study Identifier Char 12 conmed

DOMAIN Domain Abbreviation Char 2 DM

USUBJID Unique Subject Identifier Char 17 conmed

CMSEQ SEQUENCE NUMBER num
CMTRT name of the drug or therapy char conmed

CMINDC indication char conmed

CMSTDTC start date/time of medication char ISO 8601 conmed

CMENRF end relative to refenrce period Char conmed

 variable Programming Algorithm Origin Page number Role Core
STUDY ="CVAH631BIN01" CRF 2 Identifier Required
Identifier Required
Assign
= "CM" ed
Identifier Required
Derive
=concatenation (STUDY, CENTRE, PTNO) d
chronological order Identifier Required
therapy =^ missing of therapy Topic Required
Record Qualifier permissible
reason =reason
timing permissible
stdt =^ missing stdt
timing permissible
ongoing =if ongoing="Yes" then "ONGOING"
Notes
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 smoke STUDY
DOMAIN Domain Abbreviation Char 2 SU

USUBJID Unique Subject Identifier Char 17 smoke

SUSEQ SEQUENCE NUMBER num

SUTRT name of the substance Char smoke

SUCAT category of substance Char

start date/time of
sustdtc substance Char smoke
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
= "SU" Assigned Identifier Required
Identifier Required
=concatenation (STUDY,
CENTRE, PTNO) Derived
chronological order Identifier Required
Topic Required
=if smoke_="Yes" then
"CIGARETTES"
grouping permissible
=if sutrt="CIGARETTES" qualifier
then "TOBACCO"
timing permissible
= visitdt
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 DEMO STUDY

DOMAIN Domain Abbreviation Char 2 DM

Unique Subject
USUBJID Identifier Char 17 DEMO

SCSEQ SEQUENCE NUMBER num

Subject Characteristic
SCTESTCD Short Name Char demo

SCTEST Subject Characteristic Char demo

Result or Finding in
SCORRES Original Units Char demo

Character
Result/Finding
SCSTRESC in Std Format Char demo
date/time of
SCSTDTC collection Char demo
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
Identifier Required
= "DM" Assigned
Identifier Required
=concatenation (STUDY, CENTRE, PTNO) Derived
Identifier Required
=chronological order
TOPIC Required

=^ MISSING (SUBINIT) THEN "SUBJINIT"

synonym Required
qualifier
="subject initials"
result expected
qualifier

=subinit
result expected
qualifier

=scorres
timing permissible
=visitdt
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 vital STUDY
DOMAIN Domain Abbreviation Char 2 DM
USUBJID Unique Subject Identifier Char 17 vital
VSSEQ SEQUENCE NUMBER num

VSTESTCD vital sign test short name Char vital

VSTEST VITAL SIGN TEST NAME Char VITAL

VSPOS VITALSIGN POSITION OF SUBChar

Result or Finding in Original

VSORRES Units Char VITAL

VSORRESU Original Units Char VITAL

Character Result/Finding in
VSSTRESC Std Forma Char VITAL

Numeric Result/Finding in
VSSTRESN Standard Units Char VITAL

VSSTRESU Standard Units Char VITAL

VSBLFL Baseline Flag Char

VISTNUM VISIT NUMBER num
VSDTC Date/Time of Measurements
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
= "DM" Assigned Identifier Required
=concatenation (STUDY, CENTRE, PTNO) Derived Identifier Required
=chronological order Identifier Required
TOPIC Required
="WEIGHT" "HEIGHT" "pulse",
"SYSBP","DIABP"
synonym Required
qualifier
="weight" "height" "pulse rate" "systolic
blood pressure" "diastolic blood pressure"
RECORD PERMISSIBLE
=IF VSTEST="systolic blood pressure" OR QUALIFIE
"diastolic blood pressure" THEN R
VSPOS="SITTING"
RESULT EXPECTED
QUALIFIE
R
=WEIGHT HEIGHT PULSE SYSBP DIABP
VARIABLE EXPECTED
=IF VSORRES=WEIGHT THEN "kg" QUALIFIE
HEIGHT="cm" PULSE="bpm" SYSBP R
DIABP= UNITS
RESULT EXPECTED
QUALIFIE
R
=VSORRES
RESULT EXPECTED
QUALIFIE
R
=VSORRES
VARIABLE EXPECTED
=IF VSORRES=WEIGHT THEN "kg" QUALIFIE
HEIGHT="cm" PULSE="bpm" SYSBP R
DIABP= UNITS
RECORD EXPECTED
=IF^ MISSING (ORRES) AND DTC <RFSTDTC QUALIFIE
THEN BLFL="Y"; R

= SUBSTR(VISIT,6,1) TIMING EXPECTED

=VISITDT TIMING EXPECTED
StudyID Domain ARM ARMCD ETCD ELEMENT
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg SCRN Screening
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg D80mg Drug 80/12.5mg
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg FUP Follow up
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 160/25mg SCRN Screening
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 160/25mg D160mg Drug 160/25mg
CVAH631BIN01 TA CO-DIOVAN 80mg/12.5mg drug 160/25mg FUP Follow up
TABRANCH TATRANS EPOCH
Screening
Randamization to drug 80/12.5mg treatment
followup
Screening
Randamization to drug 160/25mg treatment
followup
StudyID Domain ETCD ELEMENT TESTRL
CVAH631BTE SCRN Screening Informed consent obtained or screening
CVAH631BTE D80mg Drug 80/12.5mg start of study drug treament
CVAH631BTE FUP Follow up drug 80/12.5mg administered
CVAH631BTE SCRN Screening Informed consent obtained or screening
CVAH631BTE D160mg Drug 160/25mg start of study drug treament
CVAH631BTE FUP Follow up drug 80/12.5mg administered
TEENRL TEDUR
before start of study drug P1D
drug 80/12.5mg administered P4W
end of the treatment p12w
before start of study drug P1D
drug 80/12.5mg administered P4W
end of the treatment p12w
StudyID Domain visitnum visit ARM ARMCD TVSTRL
CVAH631BTV 1 Day 1 CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg Informed c
CVAH631BTV 2 week4 CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg start of st
CVAH631BTV 3 week12 CO-DIOVAN 80mg/12.5mg drug 80mg/12.5mg drug 80/12
CVAH631BTV 1 Day 1 CO-DIOVAN 80mg/12.5mg drug 160/25mg Informed c
CVAH631BTV 2 week4 CO-DIOVAN 80mg/12.5mg drug 160/25mg start of st
CVAH631BTV 3 week12 CO-DIOVAN 80mg/12.5mg drug 160/25mg drug 80/12
TVENRL
before start of study drug
drug 80/12.5mg administered
end of the treatment
before start of study drug
drug 80/12.5mg administered
end of the treatment
StudyID Domain IETESTCD IETEST IECAT
CVAH631BTI incl01 Male or female, ≥18 years of age INCLUSION

Patients with mean sitting BP >140/90

mm Hg (SBP >130/80 mmHg
for diabetics) and uncontrolled on
CVAH631BTI incl02 current monotherapy INCLUSION

As replacement therapy in patients

already receiving Valsartan and
hydrochlorothiazide at the same dose
CVAH631BTI incl03 levels from separate tablets INCLUSION

Women who are pregnant, intending to

become pregnant or
CVAH631BTI EXCL01 breastfeeding EXCLUSION

Severe medical condition(s) that in the

view of the Investigator
prohibits participation in the study e.g.
severe renal or hepatic
CVAH631BTI EXCL02 impairment EXCLUSION

Hypersensitivity to Diovan (Valsartan)

or HCT or any of the
CVAH631BTI EXCL03 components in the formulation EXCLUSION
 Length
/
Signifi Control
cant led
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 ADVERSE STUDY
DOMAIN Domain Abbreviation Char 2 AE
USUBJID Unique Subject Identifier Char 17 ADVERSE
AESEQ SEQUENCE NUMBER num

End
Relative
to Reported Term for the
Reference Adverse Event Char ADVERSE EVENT

Period Lowest Level Term Char

AEDECOD Dictionary-Derived Term CharChar

AESEV Severity/Intensity Char ADVERSE SEV_

AESER Serious Event Char ADVERSE AEYN

Action Taken with Study

AEACN Treatment ADVERSE ACTION_

AEREL Causality ADVERSE RELATION_

Start Date/Time of Adverse

AESTDTC Event Char ADVERSE STDT
END Date/Time of Adverse
AEENDTC Event Char ADVERSE ENDT

End Relative to Reference

AEENRF Period Char ADVERSE ONGOING
 Programming Algorithm Origin Page number Role Core
="CVAH631BIN01" CRF 2 Identifier Required
= "AE" Assigned Identifier Required
=concatenation (STUDY, CENTRE, PTNO) Derived Identifier Required
=chronological order Identifier Required
TOPIC Required

= ^ MISSING (EVENT)
VARIABLE EXPECTED
QUALIFIE
R
SYNONYM Required
QUALIFIE
R

RECORD PERMISSIBLE
QUALIFIE
=SEV_ R
RECORD EXPECTED
=IF AEYN="NO" THEN AESER="N" IF QUALIFIE
AEYN="YES" THEN AESER="Y" R
RECORD EXPECTED
QUALIFIE
R
=IF ACTION_="No action taken" THEN AEACN="NOT
APPLICABLE" IF ACTION_="DOSE ADJUSTMENT
THEN AEACN="DOSE REDUCED"
RECORD EXPECTED
=IF RELATION_="Not suspected" THEN AEREL="NOT QUALIFIE
RELATED" IF RELATION_=" suspected" THEN R
AEREL="RELATED"
TIMING EXPECTED

= STDT ISO8601
TIMING EXPECTED
=ENDT ISO8601
TIMING PERMISSIBLE

= IF ONGOING="YES" THEN "ONGOING"

 Notes

DATA IS NOT AVAILABLE IN RAW DATASET

DATA IS NOT AVAILABLE IN RAW DATASET

 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 QS STUDY

Domain
DOMAIN Abbreviation Char 2 AE
Unique Subject
USUBJID Identifier Char 17 QS
SEQUENCE
QSSEQ NUMBER num
QSTESTC SEQUENCE
D NUMBER Char QS

QSTEST Question Name Char QS

Category of
QSCAT Question Char QS ASSGMENT

SUB Category of
QSSCAT Question Char QS CATEGORY

QSORRES Finding in Original UnChar QS PATIENT P

Character
Result/Finding in
QSSTRESC Standard Format Char QS

QSBLFL Baseline Flag Char

VISITNUM Visit Number num QS VISIT

QSDTC Date/Time of FindingChar QS VISITDT
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
Identifier Required
= "QS" Assigned
Identifier Required
=concatenation (STUDY, CENTRE,
PTNO) Derived
Identifier Required
=chronological order
TOPIC Required
="PHYASIST" "PATASIST"
SYNONYM Required
= IF QSTESTCD="PHYASIST" THEN QUALIFIE
R
QSTEST="PHYSICIAN ASSESMENT" IF
QSTESTCD="PATASIST" THEN
QSTEST="PATIENT ASSESMENT"
GROUPIN Required
G
QUALIFIE
R
= ASSGMENT
GROUPIN PERMISSIBLE
G
QUALIFIE
R
= CATEGORY
RESULT EXPECTED
= IF QSTESTCD="PHYASIST" THEN QUALIFIE
R
QSORRES=PHYSICIAN IF
QSTESTCD="PATASIST" THEN
QSORRES= PATIENT
RESULT EXPECTED
QUALIFIE
R
=QSORRES
RECORD EXPECTED
= ^MISSING ORRES AND DTC <RFSTDTC QUALIFIE
THEN BLFL="Y" R
TIMING EXPECTED
= SUBSTR(VISIT)
= VISIT ISO8601 TIMING EXPECTED
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 STUDY

DOMAIN Domain Abbreviation Char 2 SV

USUBJID Unique Subject Identifier Char 17

VISITNUM VISITNUM Num

VISIT VISIT Name Char

Start Date/Time of
SVSTDTC Visit Char ISO8601
End Date/Time of
SVENDTC Visit Char ISO8601
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required

= "SV" Assigned Identifier Required

Identifier Required
=concatenation (STUDY,
CENTRE, PTNO) Derived
= SUBSTR(VISIT,6,1) Topic Required
prem
Synonym
=VISIT Qualifier
Timing exp
=VISITDT Derived
Timing exp
==min(ex.exendtc) Derived
 Length/
Significant Controlled
Variable Label Type Digits Terms Format dataset variable
STUDY ID Study Identifier Char 12 STUDY
DOMAIN Domain Abbreviation Char 2 SE

USUBJID Unique Subject Identifier Char 17

SESEQ Sequence Number Num
ETCD Element Code Num
ELEMENT Description of Element Char
SESTDTC Start Date/Time of Element char ISO86p01
SEENDTC End Date/Time of Element char ISO86p01
EPOCH Epoch char
 Programming Algorithm Origin Page number Role Core Notes
="CVAH631BIN01" CRF 2 Identifier Required
= "SV" Assigned Identifier Required
Identifier Required
=concatenation (STUDY,
CENTRE, PTNO) Derived
Identifier required
=ARM Identifier Required
#NAME? Identifier required
Timing required
Timing expected
Timing ptrm