Infliximab - yoda.yale.edu · C O N F I D E N T I A L P a g e 1 | 111 Clinical Development Infliximab C0168T22 Anonymisation Data Derivation Specification Document

C O N F I D E N T I A L P a g e 1 | 111

Clinical Development

Infliximab

C0168T22

Anonymisation Data Derivation Specification Document

Document Type Reference document

Document Version Final

Date 06 MAR 2018

Property of Janssen

Confidential

May not be used, divulged, published or otherwise disclosed

without the consent of Janssen

Anonymisation Data Derivation Specification C0168T22


Table of contents

Clinical Development .................................................................................................................................... 1

1. Datasets ................................................................................................................................................ 5

1.1. Specifications Introduction ............................................................................................................... 5

1.2. Guidelines for Preparing Data ........................................................................................................... 5

1.3. Data Files ........................................................................................................................................... 6

1.4. Data Domains .................................................................................................................................... 7

1.4.1. Demographics – DEMOG .............................................................................................................. 7

1.4.2. Administration – ADMIN ............................................................................................................... 9

1.4.3. Assess – ASSESS ........................................................................................................................... 14

1.4.4. Atrack – ATRACK ......................................................................................................................... 16

1.4.5. Clinf – CLINF ................................................................................................................................ 19

1.4.6. Comments – COMMENTS ........................................................................................................... 22

1.4.7. Criteria – CRITERIA ...................................................................................................................... 24

1.4.8. Death – DEATH ............................................................................................................................ 27

1.4.9. Follow Up – FUP .......................................................................................................................... 29

1.4.10. Health Assessment Questionnaire – HAQ................................................................................... 31

1.4.11. Jntscore – JNTSCORE ................................................................................................................... 36

1.4.12. Laboratory – LAB ......................................................................................................................... 38

1.4.13. Meds – MEDS .............................................................................................................................. 41

1.4.14. Medsumm – MEDSUMM ............................................................................................................ 44

1.4.15. Postae – POSTAE ......................................................................................................................... 46

1.4.16. Priortx – PRIORTX ........................................................................................................................ 50

1.4.17. Procinf – PROCINF ....................................................................................................................... 52

1.4.18. Ptgroup – PTGROUP .................................................................................................................... 54

1.4.19. Health Survey – QOL ................................................................................................................... 56

1.4.20. Raeval – RAEVAL ......................................................................................................................... 58

1.4.21. Rainfo – RAINFO .......................................................................................................................... 60

1.4.22. Reasons – REASONS .................................................................................................................... 62

1.4.23. Session1 – SESSION1 ................................................................................................................... 64



1.4.24. Session2 – SESSION2 ................................................................................................................... 83

1.4.25. Thumbda1– THUMBDA1 ........................................................................................................... 102

1.4.26. Thumbda2– THUMBDA2 ........................................................................................................... 105

1.4.27. Visits – VISITS ............................................................................................................................ 108

1.4.28. Chest X-Ray – XRAY ................................................................................................................... 110



Status and Version Release Date Summary of Key Changes



1. Datasets

1.1. Specifications Introduction This specification for each dataset will be in two parts

• Dataset description

• Variables within dataset

Part I: Dataset description

Dataset Name of dataset Creating Program The program that created the dataset Description Short description Unique Identifier Unique key Sorted by Sort key Notes Any useful notes

Part II: Variables within dataset

Variable SAS variable name

Type Character or Numeric

Label SAS variable label

Codes Codelist name

Comments Variable source derivation explanation if variable derived.

1.2. Guidelines for Preparing Data The data will be provided according to the De-identified/ Anonymisation data guidelines

standards with the following exceptions:

• Subject initials will not be provided.

• Investigator Name will not be provided.

• Date of birth will not be provided, only age in years and grouped to protect PII

as per HIPAA rules (ages above 89 will be assigned to 90+).

• Subject and site/ center numbers will be assigned in a random manner so they

are not matching the subject and site/ center numbers that were used in the

actual trial.

• Remove the free text verbatim terms.

• Remove “Other” free text terms.

• Drug Record Number will not be provided.

• Drug Sequence Number will not be provided.

• Accession Number will not be provided.

• Central Lab Specimen Label Number will not be provided.

• Lab Identifier information will not be provided.



• Vendor Panel Comments will not be provided.

• Vendor Test Specific Comments will not be provided.

• Lab Name information will not be provided.

• All original dates relating to individuals subject will be removed. Instead a

Relative study day would be provided.

• Complete missing value variables will be removed.

• Partial date’s relative day cannot be calculated.

• Dataset used for data reconciliation, CRF page information will not be submitted

(e.g. AEOCCUR,LTRACK,PGTRCK).

• Datasets CRESUL, CFINAL contains PK related information hence will be

dropped.

• CONPROC dataset will not submit to protect PII.

• Surgery data will not be submitted, it may reveal PII info.

• Medical History (MEDHX) data will not be submitted.

• ECONOM dataset will not be submitted as it captures personal information of

subject’s economic status hence may lead to PII.

• Screen failure data will be removed from all domains, which has no impact on

secondary analysis.

1.3. Data Files The C0168T22 Clinical Study Report (CSR) data should be used for converting to de-

identification. Use the C0168T22 CSR data from the following folders.



1.4. Data Domains

1.4.1. Demographics – DEMOG

Dataset DEMOG

Creating program demog.sas

Description Demographics

Unique identifier DUNIQUEP

Sorted by DUNIQUEP

Notes Below listed variables will be dropped from dataset to protect PII as per

HIPAA and EMA guidelines or due to non significant elements or due to

missing values:

STUDYSEG,PAGE,PAGE_SEQ,PAGE_SEC,PERIOD,MONTH,DAY,YEAR,HOUR,MI

NUTE,DATE_COL,TIME_COL,DERIV_DT,INITIALS,DOB,RACE_OTH,DOB_MON,D

OB_DAY,DOB_YR,STD_WGT,HOSPADT,HOSPAMON,HOSPADAY,HOSPAYR,

ZHGT, ZHGT_UN

Variable Type Label Codes Comments

DUNIQUEP char Unique_P assigned for de-

identity

Randomly assigned Unique_P for de-identity

C_PERIOD char Coded data collection period

for chronol

Collected at CRF.

PROTOCOL char Protocol number, derived

from Unique_pat

Collected at CRF.




DSITE char Site number assigned for de-

identity

Randomly assigned Site number for de-identity

DPATIENT char Patient number assigned for

de-identity

Randomly assigned Patient number for de-identity

SEX char Sex Collected at CRF.

RACE char Race Group the element to protect PII.

HGT char Derived height in centimeters Group the element to protect PII.

TRTMENT char Assigned treatment group Collected at CRF.

AGE char Age in Years If age is greater than 89 then group to "90+" otherwise AGE=AGE.

Grouping will be performed based on HIPAA

privacy rules.

DERIV_DY num Relative Derived Day derived

item val(s)

If DERIV_DT and CONSDATE not missing then

perform below logic to calculate DERIV_DY, If

DERIV_DT less than CONSDATE then (DERIV_DT -

CONSDATE).Else if DERIV_DT is greater than equal

to CONSDATE then (DERIV_DT- CONSDATE) +1.



1.4.2. Administration – ADMIN

Dataset ADMIN

Creating program admin.sas

Description Administration

Unique identifier DUNIQUEP, C_PERIOD

Sorted by DUNIQUEP, C_PERIOD



missing values:

PAGE,PAGE_SEQ,PAGE_SEC,PERIOD,MONTH,DAY,YEAR,HOUR,MINUTE,DATE

_COL,TIME_COL,DERIV_DT,ADM_MAT,PATGROUP,STARTDT,ENDDT,DOSE,DO

SE_UN,WGT,TOTAL_MG,MIXED_MG,MIXED_ML,ROUTECOD,RANDCODE,LOT

_NUM,VIALS,VIAL_NUM,CONTDOSE,EARLY_AE,TESTDT,TESTTIME,T_STDT,T_E

NDDT,FOREARM,REACTION,EXTRAVAS,STARTMON,STARTDAY,STARTYR,END

MON,ENDDAY,ENDYR,TESTMON,TESTDAY,TESTYR,TESTHR,TESTMIN,T_STMO

N,T_STDAY,T_STYR,T_ENDMON,T_ENDDAY,T_ENDYR,KIT_NUM,ADMIN_SP,R

SN_SPEC,CONSENT,A_VIAL,B_VIAL,UNBLDDAY,UNBLDMON,UNBLDYR,UNBLD

DT,UNBLDHR,UNBLDMIN,UNBLDTIM,ILLNESS,ALT_THPY,ENROLMON,ENROLY

R,ENROLDT,ENROLHR,ENROLMIN,ENROLTIM,LC_DAY,LC_MON,LC_YR,LC_ENR

DT,AE_PAGE,AE_PSEQ,AE_LINE



identity






for chronol

Collected at CRF.

STUDYSEG char Study segment identifier Collected at CRF.


from Unique_pat

Collected at CRF.


identity



de-identity


DOSE_SEQ num Number of dose within

sequence of doses

Collected at CRF.

NOTDOSED char Yes if study material was not

administer

Collected at CRF.

STARTTIM num Derived time study material

administrati

Collected at CRF.

STOPTIM num Derived time infusion was

interrupted

Collected at CRF.

RSTRTTIM num Derived time infusion was

restarted

Collected at CRF.

ENDTIM num Derived time study material

administrati

Collected at CRF.

TOTAL_ML num Total ml administrated (in ml) Collected at CRF.

TEST_ND char Indicates test dose was not

administered

Collected at CRF.




T_STTIM num Derived time test dose started Collected at CRF.

T_ENDTIM num Derived time test dose ended Collected at CRF.

TEST_ML num Test dose volume (in ml) Collected at CRF.

STARTHR char Hour study material

administration start

Collected at CRF.

STARTMIN char Minute portion of time study

material ad

Collected at CRF.

STOPHR char Hour portion of time infusion

was interr

Collected at CRF.

STOPMIN char Minute portion of time

infusion was inte

Collected at CRF.

RSTRTHR char Hour portion of time infusion

was restar

Collected at CRF.

RSTRTMIN char Minute portion of time

infusion was rest

Collected at CRF.

ENDHR char Hour study material

administration ended

Collected at CRF.

ENDMIN char Minute portion of time study

material ad

Collected at CRF.

T_STHR char Hour test dose started Collected at CRF.

T_STMIN char Minute portion of time test

dose started

Collected at CRF.

T_ENDHR char Hour test dose ended Collected at CRF.




T_ENDMIN char Minute portion of time test

dose ended

Collected at CRF.

INTERRUP char Indicates if infusion was

interrupted

Collected at CRF.

AE char Indicates adverse experience

as reason

Collected at CRF.

ADMIN char Indicates administrative

reason

Collected at CRF.

OTH_REAS char Indicates other reason Collected at CRF.

TOTAL_AD char Indicates total dose

administered

Collected at CRF.

NOTTREAT char Indicates if patient was

randomized but

Collected at CRF.

UNBLMAT char Indicates if study material

unblinded

Collected at CRF.

ENROLDAY char Day of month of enrollment in

study

Collected at CRF.

LC_HR char Hour portion of time of

enrollment in st

Collected at CRF.

LC_MIN char Minute portion of time of

enrollment in

Collected at CRF.

LC_ENRTM num Time of enrollment (site's

time)

Collected at CRF.




PROP_GIV char Indicates whether or not

prophylactic wa

Collected at CRF.


item val(s)


perform below logic to calculate DERIV_DY,If




ENDDY num Relative Derived Day std mat

adminstrati

If ENDDT and CONSDATE not missing then perform

below logic to calculate ENDDY,If ENDDT less than

CONSDATE then (ENDDT - CONSDATE).Else if

ENDDT is greater than equal to CONSDATE then

(ENDDT- CONSDATE) +1.

LC_ENRDY num Relative Day of enrollment

(site's Day)

If LC_ENRDT and CONSDATE not missing then

perform below logic to calculate LC_ENRDY,If

LC_ENRDT less than CONSDATE then (LC_ENRDT -

CONSDATE).Else if LC_ENRDT is greater than equal

to CONSDATE then (LC_ENRDT- CONSDATE) +1.

STARTDY num Relative Derived Day std mat

adminstrati

If STARTDT and CONSDATE not missing then

perform below logic to calculate STARTDY,If

STARTDT less than CONSDATE then (STARTDT -

CONSDATE).Else if STARTDT is greater than equal

to CONSDATE then (STARTDT- CONSDATE) +1.



1.4.3. Assess – ASSESS

Dataset ASSESS

Creating program assess.sas

Description Assess





missing values:

PAGE,PAGE_SEQ,PAGE_SEC,MONTH,DAY,YEAR,HOUR,MINUTE,DATE_COL,TI

ME_COL,DERIV_DT,ASSESSND,GN_BACT,GN_FOCAL,GP_FOCAL,GP_BACT,FU

NGAL,VIRAL,NEG_CULT,NOT_INFC,OTH_AGT,A_STATUS,DOD,TOD,AUTOPSY,

CAUS_DTH,PROBCAUS,LTF_DT,LTF_REAS,HOSPDDT,NOTDHOSP,DIS_REAS,DIS

OTHER,CIDISDT,NOTDICU,DOD_MON,DOD_DAY,DOD_YR,TOD_HR,TOD_MIN,

LTF_MON,LTF_DAY,LTF_YR,HOSPDMON,HOSPDDAY,HOSPDYR,CIDISMON,CID

ISDAY,CIDISYR,EFF_PAT,EFF_EVAL,STDY_COM,PAGE_1,PAG_SEQ1,PAG_SEC1,

PAGE_2,PAG_SEQ2,PAG_SEC2,PAGE_3,PAG_SEQ3,PAG_SEC3,PAGE_4,PAG_S

EQ4,PAG_SEC4,COLECT,ELEC_COL,COL_REAS,COL_DATE,COL_MON,COL_DAY

,COL_YR,VISIT_WK,DISCINIT,INITSPEC



identity






for chronol

Collected at CRF.


PERIOD char Data collection period Collected at CRF.


from Unique_pat

Collected at CRF.


identity



de-identity


STDYSTAT char Indicates patient's further

participatio

Collected at CRF.


item val(s)








1.4.4. Atrack – ATRACK

Dataset ATRACK

Creating program atrack.sas

Description Atrack





missing values:


ME_COL,DERIV_DT,LABELNUM,SAMPLMON,SAMPLDAY,SAMPLYR,SAMPLDT,

SENT_MON,SENT_DAY,SENT_YR,SENT_DT,RCVD,RCVD_MON,RCVD_DAY,RCV

D_YR,RCVD_DT,ZWGT,ZWGT_UN,WGT



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


ASSAY char Code for type of assay Collected at CRF.

NOT_COLL char Yes if laboratory specimen not

collected

Collected at CRF.

SAMPLHR char Hour portion of time assay

sample was co

Collected at CRF.

SAMPLMIN char Minute portion of time assay

sample was

Collected at CRF.

SAMPLTIM num Derived time assay sample

was collected

Collected at CRF.

SENT char Was assay sample sent to

laboratory by c

Collected at CRF.

OBTAINED char Indicates whether a sample

was collected

Collected at CRF.

VOLUME num Sample volume (in ml) Collected at CRF.





item val(s)






SAMPLDY num Relative Derived Day ass.

samp collected

If SAMPLDT and CONSDATE not missing then

perform below logic to calculate SAMPLDY,If

SAMPLDT less than CONSDATE then (SAMPLDT -

CONSDATE).Else if SAMPLDT is greater than equal

to CONSDATE then (SAMPLDT- CONSDATE) +1.



1.4.5. Clinf – CLINF

Dataset CLINF

Creating program clinf.sas

Description Clinf





missing values:

PAGE,PAGE_SEQ,PAGE_SEC,MONTH,DAY,YEAR,DATE_COL,DERIV_DT,VITAL_

ND,BP_MTH,BPMED,RR,RR_ND,POSITION,HGT,ON_VENT,INTUB,ON_PACE,PE

EP,PEEP_ND,PIP,PIP_ND,TIDAL,TIDAL_ND,SHOCK,SHOCK_ND,ARDS,ARDS_ND

,ZWGT,ZWGT_UN,ZHGT,ZHGT_UN,HGT_ND,ZPEEP,ZPEEP_UN,ZPIP,ZPIP_UNI



identity



for chronol

Collected at CRF.



HOUR char Hour part of time Collected at CRF.

MINUTE char Minute part of time Collected at CRF.





from Unique_pat

Collected at CRF.


identity



de-identity


TIME_COL num Derived time of data

collection

Collected at CRF.

TEMP num Derived body temperature in

degrees Cent

Collected at CRF.

TEMP_ND char Temperature not measured Collected at CRF.

SYST num Systolic blood pressure

measurement in m

Collected at CRF.

DIAS num Diastolic blood pressure

measurement in

Collected at CRF.

BP_ND char Blood pressure not measured Collected at CRF.

HR num Heart rate in beats/minute Collected at CRF.

HR_ND char Heart rate not measured Collected at CRF.

WGT char Derived patient weight in

kilograms

Group the element to protect PII.

ZTEMP num Entered body temperature Collected at CRF.

ZTEMPMTH char Method used to measure

body temperature

Collected at CRF.




WGT_ND char Weight not measured Collected at CRF.

PE_PERF char Indicates if physical exam

performed

Collected at CRF.

DATE_CDY num Relative Derived Day of data

collection

If DATE_COL and CONSDATE not missing then

perform below logic to calculate ,If DATE_COL less

than CONSDATE then (DATE_COL -

CONSDATE).Else if DATE_COL is greater than equal

to CONSDATE then (DATE_COL- CONSDATE) +1.


item val(s)








1.4.6. Comments – COMMENTS

Dataset COMMENTS

Creating program comments.sas

Description Comments data

Unique identifier Not Applicable

Sorted by Not Applicable

Notes Comments data is sensitive data, contains free text information. Will be

submitted empty dataset.



identity

Empty dataset will be submitted.


for chronol


STUDYSEG char Study segment identifier Empty dataset will be submitted.

PERIOD char Data collection period Empty dataset will be submitted.


from Unique_pat



identity



de-identity





COMMENTS char Comment about patient to

clarify any pre


FOR_PAGE char Number(s) of CRF page(s) to

which commen



item val(s)




1.4.7. Criteria – CRITERIA

Dataset CRITERIA

Creating program criteria.sas

Description Criteria





missing values:


NUTE,DATE_COL,TIME_COL,DERIV_DT,INC_1A,INC_1B,INC3C,INC3D,INC3E,IN

C3F,INC3G,INC3H,INC4A,INC4B,INC5A,INC5B,INC5C,INC5D,INC12A,INC12B,IN

C31,INC32,INC33,INC34,CONSDATE,CONSTIME,ENROLDT,ENROLTIM,CONS_

MON,CONS_DAY,CONS_YR,CONS_HR,CONS_MIN,ENROLMON,ENROLDAY,EN

ROLYR,ENROLHR,ENROLMIN



identity



for chronol

Collected at CRF.


from Unique_pat

Collected at CRF.





identity



de-identity


INC1 char Criteria number 1 Collected at CRF.



INC3A char Criteria number 3a Collected at CRF.

INC3B char Criteria number 3b Collected at CRF.
































item val(s)








1.4.8. Death – DEATH

Dataset DEATH

Creating program death.sas

Description Death





missing values:


ME_COL,DERIV_DT,DOD,DOD_MON,DOD_DAY,DOD_YR,PROBCAUS



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.


identity






de-identity


TOD num Derived time of patient death Collected at CRF.

TOD_HR char Hour of patient death Collected at CRF.

TOD_MIN char Minute of patient death Collected at CRF.

AUTOPSY char Indicates if autopsy was

performed

Collected at CRF.

CAUS_DTH char Code for most likely cause of

patient's

Collected at CRF.


item val(s)






DODDY num Relative Derived day of

patient death

If DOD and CONSDATE not missing then perform

below logic to calculate ,If DOD less than

CONSDATE then (DOD - CONSDATE).Else if DOD is

greater than equal to CONSDATE then (DOD-

CONSDATE) +1.



1.4.9. Follow Up – FUP

Dataset FUP

Creating program fup.sas

Description Follow Up

Unique identifier DUNIQUEP, C_PERIOD, STUDYSEG

Sorted by DUNIQUEP, C_PERIOD, STUDYSEG



missing values:


ME_COL,DERIV_DT,PRE_SITE,PRE_PAT,CAUSE,DOD_MON,DOD_YR,LTF_MON

,LTF_YR,PRE_PROT,INFO_SRC,DATE_COL



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


CATEGORY char Indicates type of AE reported Collected at CRF.

RESPONSE char Indicates presence of adverse

event

Collected at CRF.

DIED char Has the patient died? Collected at CRF.


item val(s)








1.4.10. Health Assessment Questionnaire – HAQ

Dataset HAQ

Creating program haq.sas

Description Health Assessment Questionnaire





missing values:


ME_COL,DERIV_DT,SPEC1,SPEC2



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


Q1 char Question 1 Collected at CRF.























CAT1 char Aid, device or help category 1 Collected at CRF.









CAT10 char Aid, device or help category

10

Collected at CRF.


11

Collected at CRF.


12

Collected at CRF.


13

Collected at CRF.


14

Collected at CRF.





15

Collected at CRF.


16

Collected at CRF.


17

Collected at CRF.


18

Collected at CRF.


19

Collected at CRF.


20

Collected at CRF.


21

Collected at CRF.


22

Collected at CRF.


23

Collected at CRF.




DATE_CDY num Relative Derived day of data

collection







item val(s)








1.4.11. Jntscore – JNTSCORE

Dataset JNTSCORE

Creating program jntscore.sas

Description Jntscore





missing values:


ME_COL,DERIV_DT,SWELLING,JOINT_ND,INCR_WAR,EFFUSION,SYN_THIC,JL_

TEND,AM_STIFF,INACT_ST



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


JOINT char Code indicating joint Collected at CRF.

PAIN char Pain score for joint Collected at CRF.

SWEL_SEV char Swelling severity score for

joint

Collected at CRF.

NOTEVALA char Reason A why joint not

evaluable

Collected at CRF.

NOTEVALB char Reason B why joint not

evaluable

Collected at CRF.


collection







item val(s)








1.4.12. Laboratory – LAB

Dataset LAB

Creating program lab.sas

Description Laboratory data

Unique identifier DUNIQUEP, TESTCODE,C_PERIOD,DATE_CDY,DERIV_TM

Sorted by DUNIQUEP, TESTCODE,C_PERIOD,DATE_CDY,DERIV_TM



missing values:

PAGE,PAGE_SEQ,PAGE_SEC,MONTH,DAY,YEAR,DATE_COL,DERIV_DT,LAB_CO

DE,LABELNUM



identity



for chronol

Collected at CRF.



HOUR char Hour part of time Collected at CRF.

MINUTE char Minute part of time Collected at CRF.





from Unique_pat

Collected at CRF.


identity



de-identity


TIME_COL num Derived time of data

collection

Collected at CRF.

TESTCODE char Code for lab test Collected at CRF.

NORM_VAR char Code for variation of normal

range assoc

Collected at CRF.

ENT_RES char Quantitative or qualitative lab

test res

Collected at CRF.

UNITS char Collected at CRF.

NORMAL_L char Collected at CRF.

NORMAL_H char Collected at CRF.

TESTCOMM char Code for flagging test not

performed or

Collected at CRF.

HILOFLAG char Flag indicating normal or

abnormal labor

Collected at CRF.

NORM_ID char ID of normal range record

containing res

Collected at CRF.

US_RES char Test result converted to

standard units

Collected at CRF.




US_UNITS char Collected at CRF.

US_FLAG char Flag indicating US_RESULT's

datatype or

Collected at CRF.

IS_RES char Test result converted to

standard units

Collected at CRF.

IS_UNITS char Collected at CRF.

IS_FLAG char Flag indicating IS_RESULT's

datatype or

Collected at CRF.

UNIT_SET char Standard unit set containing

units for U

Collected at CRF.


collection






DERIV_TM num Derived Time derived item

val(s)

If DERIV_DT contains timepart then DERIV_TM is

timepart(DERIV_DT).


item val(s)








1.4.13. Meds – MEDS

Dataset MEDS

Creating program meds.sas

Description Meds





missing values:


ME_COL,DERIV_DT,CRX_NAME,RX_NAME,DOSEFREQ,ROUTE,RX_IND,RXST_D

T,RXST_TIM,RXENDDT,RXENDTIM,RX_REAS,RXST_MON,RXST_DAY,RXST_YR,R

XST_HR,RXST_MIN,RXENDMON,RXENDDAY,RXENDYR,RXENDHR,RXENDMIN,P

RIOR_EN



identity



for chronol

Collected at CRF.







from Unique_pat

Collected at CRF.


identity



de-identity


LINE_NO num CRF line number reference Collected at CRF.

RX_CODE char Code for concomitant

medication

Collected at CRF.

RXACSTAT char Code for status of most recent

Rx autoen

Collected at CRF.

RX_FREQ char Code for frequency of

concomitant medica

Collected at CRF.

DOSAGE char Dose of concomitant

medication

Collected at CRF.

DOSEUNTS char Code for units of concomitant

medication

Collected at CRF.

ROUT_COD char Code for route of concomitant

medication

Collected at CRF.

REAS_CHG char Reason for change in

medication

Collected at CRF.

RX_CONT char Does patient continue to take

concomitan

Collected at CRF.





item val(s)






RXENDDY num Relative Der. Day pt strt.

taking conc

If RXENDDT and CONSDATE not missing then

perform below logic to calculate RXENDDY,If

RXENDDT less than CONSDATE then (RXENDDT -

CONSDATE).Else if RXENDDT is greater than equal

to CONSDATE then (RXENDDT- CONSDATE) +1.

RXST_DY num Relative Der .Day pt stop.

taking conc

If RXST_DT and CONSDATE not missing then

perform below logic to calculate RXST_DY,If

RXST_DT less than CONSDATE then (RXST_DT -

CONSDATE).Else if RXST_DT is greater than equal

to CONSDATE then (RXST_DT- CONSDATE) +1.



1.4.14. Medsumm – MEDSUMM

Dataset MEDSUMM

Creating program medsumm.sas

Description Medsumm

Unique identifier DUNIQUEP, C_PERIOD, RX_CODE

Sorted by DUNIQUEP, C_PERIOD, RX_CODE



missing values:


NUTE,DATE_COL,TIME_COL,DERIV_DT,RX_CAT,CRX_NAME,RX_NAME,WITHI

N14,BEYOND14,PREVIOUS,CUR_TAK,METH_6MO,METH_3MO,RESPONSE,TO

XICITY



identity



for chronol

Collected at CRF.


from Unique_pat

Collected at CRF.


identity






de-identity


RX_CODE char Code for specific drug Collected at CRF.

RXACSTAT char Code for status of most recent

Rx autoen

Collected at CRF.

PREINF char Indicates patient on

medication prior to

Collected at CRF.

NOT_ON char Indicates medication not

administered to

Collected at CRF.

MON_DISC char Total months therapy

discontinued

Collected at CRF.

CUM_DOSE char Code indicating cumulative

dose

Collected at CRF.


item val(s)








1.4.15. Postae – POSTAE

Dataset POSTAE

Creating program postae.sas

Description Postae





missing values:


ME_COL,DERIV_DT,AE_CODE,CAE_DESC,AE_DESC,PRIMTERM,ONSETDT,RESO

LDT,FREQ,SERIOUS,SERIOUS1,SERIOUS2,SERIOUS3,SERIOUS4,SERIOUS6,SERI

OUS9,SERIOU10,SERIOU11,RELATION,AE_RELAT,AE_REL2,ACTION,AE_ACT,AE

_ACT2,OUTCOME,DECHALL,DECHALL2,RECHALL,RECHALL2,ONSETMON,ONSE

TDAY,ONSETYR,RESOLMON,RESOLDAY,RESOLYR



identity



for chronol

Collected at CRF.







from Unique_pat

Collected at CRF.


identity



de-identity


AE_LINE num Line number reference of

adverse experie

Collected at CRF.

WHOART char WHOART AE code generated

by AE autoencod

Collected at CRF.

AEACSTAT char Code for status of most recent

AE autoen

Collected at CRF.

ONSETTIM num Time of AE onset, derived

from onset hou

Collected at CRF.

RESOLTIM num Time of AE resolution,derived

from resol

Collected at CRF.

CONT char Yes if adverse event continued

(i.e., wa

Collected at CRF.

SEVERITY char Code for severity of adverse

event

Collected at CRF.

SERIOUS5 char AE severity code indicating

initial/prol

Collected at CRF.


cancer

Collected at CRF.





none of the

Collected at CRF.

AE_REL char Code for relationship of

adverse event t

Collected at CRF.

ACT_TAK char Code for action taken with

study agent

Collected at CRF.

AE_TREAT char Code indicating if AE was

treated or not

Collected at CRF.

CLASS char Code indicating classification

of AE

Collected at CRF.

INFECT char Code indicating if patient had

an infect

Collected at CRF.

ONSETHR char Hour portion of time of

adverse event on

Collected at CRF.

ONSETMIN char Minute portion of time of

adverse event

Collected at CRF.

RESOLHR char Hour portion of time of

adverse event re

Collected at CRF.

RESOLMIN char Minute portion of time of

adverse event

Collected at CRF.

AE_PREF char Collected at CRF.

PREFTERM char Collected at CRF.

AE_CLASS char Collected at CRF.

CLASSDSC char Collected at CRF.





item val(s)






ONSETDY num Relative Day of AE onst, der.

frm onst mon

If ONSETDT and CONSDATE not missing then

perform below logic to calculate ONSETDY,If

ONSETDT less than CONSDATE then (ONSETDT -

CONSDATE).Else if ONSETDT is greater than equal

to CONSDATE then (ONSETDT- CONSDATE) +1.

RESOLDY num Relative Date of AE reso, der.

from reso

If RESOLDT and CONSDATE not missing then

perform below logic to calculate RESOLDY,If

RESOLDT less than CONSDATE then (RESOLDT -

CONSDATE).Else if RESOLDT is greater than equal

to CONSDATE then (RESOLDT- CONSDATE) +1.



1.4.16. Priortx – PRIORTX

Dataset PRIORTX

Creating program priortx.sas

Description Priortx





missing values:


NUTE,DATE_COL,TIME_COL,DERIV_DT,MAB_MANF



identity



for chronol

Collected at CRF.


from Unique_pat

Collected at CRF.


identity



de-identity





RCVD_MAB char Indicates if patient received

prior trea

Collected at CRF.

MAB char Chimeric or mouse

monoclonal antibody

Collected at CRF.


item val(s)








1.4.17. Procinf – PROCINF

Dataset PROCINF

Creating program procinf.sas

Description Procinf





missing values:


ME_COL,DERIV_DT,PROCDATE,PROCMON,PROCDAY,PROCYEAR,PROCND,SIG

_EVAL,COL_EVAL



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


ECG_RES char Indicates ECG was normal or

abnormal

Collected at CRF.


item val(s)






PROCDADY num Relative Derived day of

procedure

If PROCDATE and CONSDATE not missing then

perform below logic to calculate ,If PROCDATE less

than CONSDATE then (PROCDATE -

CONSDATE).Else if PROCDATE is greater than equal

to CONSDATE then (PROCDATE- CONSDATE) +1.



1.4.18. Ptgroup – PTGROUP

Dataset PTGROUP

Creating program ptgroup.sas

Description Ptgroup





missing values:


NUTE,DATE_COL,TIME_COL,DERIV_DT,PATGROUP,STAGE,NR_SPEC,INF_DATE

,INF_MON,INF_DY,INF_YR



identity



for chronol

Collected at CRF.


from Unique_pat

Collected at CRF.


identity






de-identity


EXT_TRT char Indicates if patient will

participate in

Collected at CRF.

NR_REAS char Coding indicating reason for

non-retreat

Collected at CRF.


item val(s)






INF_DADY num Relative Date of first

retrtment infusio

If INF_DATE and CONSDATE not missing then

perform below logic to calculate ,If INF_DATE less

than CONSDATE then (INF_DATE - CONSDATE).Else

if INF_DATE is greater than equal to CONSDATE

then (INF_DATE- CONSDATE) +1.



1.4.19. Health Survey – QOL

Dataset QOL

Creating program qol.sas

Description SF-36 Health Survey





missing values:


ME_COL,DERIV_DT



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.


identity






de-identity


QUESTION char Health survey question

number

Collected at CRF.

SCORE char Score for health survey

question

Collected at CRF.


collection







item val(s)








1.4.20. Raeval – RAEVAL

Dataset RAEVAL

Creating program raeval.sas

Description Raeval





missing values:


ME_COL,DERIV_DT,NOT_PERF,GRIP_R1,GRIP_R2,GRIP_R3,RIGHT_ND,GRIP_L

1,GRIP_L2,GRIP_L3,LEFT_ND,GRIPUNIT,STIFSCOR,RSP_PAT,RSP_EVAL,SEV_PA

T,SEV_EVAL,EFF_PAT,EFF_EVAL



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


SWELL char Indicates soft tissue swelling

in tendon

Collected at CRF.

MORNSTIF num Duration of morning stiffness

(in minute

Collected at CRF.

SCORUNIT char Units used for scoring items Collected at CRF.

PAINSCOR num Pain score Collected at CRF.

TIRESCOR num Tiredness score Collected at CRF.

GDA_PAT num Patient's score for global

disease asses

Collected at CRF.

GDA_EVAL num Evaluator's score for global

disease ass

Collected at CRF.


collection







item val(s)








1.4.21. Rainfo – RAINFO

Dataset RAINFO

Creating program rainfo.sas

Description Rainfo





missing values:


NUTE,DATE_COL,TIME_COL,DERIV_DT,DIAG_DT,DIAG_MON,DIAG_DAY,DIAG

_YR,PATTERN,CRIT1,CRIT2,CRIT3,CRIT4,CRIT5,CRIT6,CRIT7


DUNIQUEP char Protocol, Site, and Patient

numbers in s



for chronol

Collected at CRF.


from Unique_pat

Collected at CRF.


identity






de-identity


ANASTAGE char Classification of anatomical

stage

Collected at CRF.

FUNCLASS char Classification of functional

capacity

Collected at CRF.


item val(s)






DIAG_DY num Relative Der. Day of initial diag

of RA

If DIAG_DT and CONSDATE not missing then

perform below logic to calculate DIAG_DY,If

DIAG_DT less than CONSDATE then (DIAG_DT -

CONSDATE).Else if DIAG_DT is greater than equal

to CONSDATE then (DIAG_DT- CONSDATE) +1.



1.4.22. Reasons – REASONS

Dataset REASONS

Creating program reasons.sas

Description Reasons





missing values:

PAGE_SEC,MONTH,DAY,YEAR,HOUR,MINUTE,DATE_COL,TIME_COL,DERIV_D

T,REASSPEC,DATE_DIS,MON_DISC,DAY_DISC,YR_DISC,DISCINIT,INITSPEC,DOD

,DOD_MON,DOD_DAY,DOD_YR,PAGE_2,PAG2_SEQ,P2_LINE,PAGE_3,PAG3_S

EQ,P3_LINE,PAGE_4,PAG4_SEQ,P4_LINE



identity



for chronol

Collected at CRF.


PAGE num CRF page number Collected at CRF.

PAGE_SEQ char Qualifier for CRF page number

(A,B,C)

Collected at CRF.






from Unique_pat

Collected at CRF.


identity



de-identity


REASCODE char Code for reason patient did

not complete

Collected at CRF.

PAG1 num First page number indicated. Collected at CRF.

PAG1_SEQ char First page qualifier (A,B,C) Collected at CRF.

PAG1_LIN num First page line number

indicated.

Collected at CRF.

DATE_DDY num Relative Date of

discontinuation

If DATE_DIS and CONSDATE not missing then

perform below logic to calculate ,If DATE_DIS less

than CONSDATE then (DATE_DIS - CONSDATE).Else

if DATE_DIS is greater than equal to CONSDATE

then (DATE_DIS- CONSDATE) +1.


item val(s)








1.4.23. Session1 – SESSION1

Dataset SESSION1

Creating program session1.sas

Description Session1


Sorted by DUNIQUEP


HIPAA and EMA guidelines:

ID,BLINDCOD,DATEOF



identity



de-identity


READER num Image set reader Collected at CRF.

TIMEOF char Time of image reading Collected at CRF.

ETIME char Entry time Collected at CRF.

PART num Body part Collected at CRF.

SIDE char dff Collected at CRF.

ADQA char Overall adeq. ind. hand,timept

A

Collected at CRF.




ADQA1 char PIP adeq. ind. hand, timepoint

A

Collected at CRF.

ADQA2 char MCP adeq. ind. hand,

timepoint A

Collected at CRF.

ADQA3 char Thumb adeq. ind. hand,

timepnt A

Collected at CRF.

ADQA4 char Wrist adeq. ind. hand, timepnt

A

Collected at CRF.

ADQB char Overall adeq. ind. hand,timept

B

Collected at CRF.

ADQB1 char PIP adeq. ind. hand, timepoint

B

Collected at CRF.

ADQB2 char MCP adeq. ind. hand,

timepoint B

Collected at CRF.

ADQB3 char Thumb adeq. ind. hand,

timepnt B

Collected at CRF.

ADQB4 char Wrist adeq. ind. hand, timepnt

B

Collected at CRF.

ADQC char Overall adeq. ind. hand,timept

C

Collected at CRF.

ADQC1 char PIP adeq. ind. hand, timepoint

C

Collected at CRF.

ADQC2 char MCP adeq. ind. hand,

timepoint C

Collected at CRF.




ADQC3 char Thumb adeq. ind. hand,

timepnt C

Collected at CRF.

ADQC4 char Wrist adeq. ind. hand, timepnt

C

Collected at CRF.

ADQD char Overall adeq. ind. hand,timept

D

Collected at CRF.

ADQD1 char PIP adeq. ind. hand, timepoint

D

Collected at CRF.

ADQD2 char MCP adeq. ind. hand,

timepoint D

Collected at CRF.

ADQD3 char Thumb adeq. ind. hand,

timepnt D

Collected at CRF.

ADQD4 char Wrist adeq. ind. hand, timepnt

D

Collected at CRF.

EROPIPA char Ero PIP ind. hand, timepoint A Collected at CRF.

EROPIPB char Ero PIP ind. hand, timepoint B Collected at CRF.

EROPIPC char Ero PIP ind. hand, timepoint C Collected at CRF.

EROPIPD char Ero PIP ind. hand, timepoint D Collected at CRF.

JSNPIPA char JSN PIP indicator hand, timept

A

Collected at CRF.

JSNPIPB char JSN PIP indicator hand, timept

B

Collected at CRF.

JSNPIPC char JSN PIP indicator hand, timept

C

Collected at CRF.




JSNPIPD char JSN PIP indicator hand, timept

D

Collected at CRF.

PA2 char Ero prox inter jnt 2 hand,time

A

Collected at CRF.

PB2 char Ero prox inter jnt 2 hand,time

B

Collected at CRF.

PC2 char Ero prox inter jnt 2 hand,time

C

Collected at CRF.

PD2 char Ero prox inter jnt 2 hand,time

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.

JA2 char JSN-prox inter jnt 2 hand,time

A

Collected at CRF.

JB2 char JSN-prox inter jnt 2 hand,time

B

Collected at CRF.

JC2 char JSN-prox inter jnt 2 hand,time

C

Collected at CRF.

JD2 char JSN-prox inter jnt 2 hand,time

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.

EROMCPA char Ero MCP ind. hand, timepoint

A

Collected at CRF.

EROMCPB char Ero MCP ind. hand, timepoint

B

Collected at CRF.

EROMCPC char Ero MCP ind. hand, timepoint

C

Collected at CRF.




EROMCPD char Ero MCP ind. hand, timepoint

D

Collected at CRF.

JSNMCPA char JSN MCP indicator hand,

timept A

Collected at CRF.

JSNMCPB char JSN MCP indicator hand,

timept B

Collected at CRF.

JSNMCPC char JSN MCP indicator hand,

timept C

Collected at CRF.

JSNMCPD char JSN MCP indicator hand,

timept D

Collected at CRF.

MA2 char Ero metacarp jnt 2

hand,timept A

Collected at CRF.

MB2 char Ero metacarp jnt 2

hand,timept B

Collected at CRF.

MC2 char Ero metacarp jnt 2

hand,timept C

Collected at CRF.

MD2 char Ero metacarp jnt 2

hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.





hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.

JSNA2 char JSN-metacarp jnt 2

hand,timept A

Collected at CRF.

JSNB2 char JSN-metacarp jnt 2

hand,timept B

Collected at CRF.

JSNC2 char JSN-metacarp jnt 2

hand,timept C

Collected at CRF.




JSND2 char JSN-metacarp jnt 2

hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.





hand,timept D

Collected at CRF.

EROWRIA char Ero Wrist ind. hand, timepoint

A

Collected at CRF.

EROWRIB char Ero Wrist ind. hand, timepoint

B

Collected at CRF.

EROWRIC char Ero Wrist ind. hand, timepoint

C

Collected at CRF.

EROWRID char Ero Wrist ind. hand, timepoint

D

Collected at CRF.

JSNWRIA char JSN Wrist indicator hand, time

A

Collected at CRF.

JSNWRIB char JSN Wrist indicator hand, time

B

Collected at CRF.

JSNWRIC char JSN Wrist indicator hand, time

C

Collected at CRF.

JSNWRID char JSN Wrist indicator hand, time

D

Collected at CRF.

BASEA char Metacarpal base (1),

timepoint A

Collected at CRF.

BASEB char Metacarpal base (1),

timepoint B

Collected at CRF.

BASEC char Metacarpal base (1),

timepoint C

Collected at CRF.




BASED char Metacarpal base (1),

timepoint D

Collected at CRF.

BONESA char Ero Multangulars hand,

timepnt A

Collected at CRF.

BONESB char Ero Multangulars hand,

timepnt B

Collected at CRF.

BONESC char Ero Multangulars hand,

timepnt C

Collected at CRF.

BONESD char Ero Multangulars hand,

timepnt D

Collected at CRF.

NAVA char Ero navic hand, timepoint A Collected at CRF.

NAVB char Ero navic hand, timepoint B Collected at CRF.

NAVC char Ero navic hand, timepoint C Collected at CRF.

NAVD char Ero navic hand, timepoint D Collected at CRF.

LUNA char Ero lunate hand, timepoint A Collected at CRF.

LUNB char Ero lunate hand, timepoint B Collected at CRF.

LUNC char Ero lunate hand, timepoint C Collected at CRF.

LUND char Ero lunate hand, timepoint D Collected at CRF.

RADIUSA char Ero radius hand, timepoint A Collected at CRF.

RADIUSB char Ero radius hand, timepoint B Collected at CRF.

RADIUSC char Ero radius hand, timepoint C Collected at CRF.

RADIUSD char Ero radius hand, timepoint D Collected at CRF.




ULNAA char Ero Ulna hand, timepoint A Collected at CRF.

ULNAB char Ero Ulna hand, timepoint B Collected at CRF.

ULNAC char Ero Ulna hand, timepoint C Collected at CRF.

ULNAD char Ero Ulna hand, timepoint D Collected at CRF.

CM3A char JSN Car. Met. Jnt. 3 hand,time

A

Collected at CRF.

CM3B char JSN Car. Met. Jnt. 3 hand,time

B

Collected at CRF.

CM3C char JSN Car. Met. Jnt. 3 hand,time

C

Collected at CRF.

CM3D char JSN Car. Met. Jnt. 3 hand,time

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.





C

Collected at CRF.


D

Collected at CRF.

MULTA char JSN mult navic jnt hand,timept

A

Collected at CRF.

MULTB char JSN mult navic jnt hand,timept

B

Collected at CRF.

MULTC char JSN mult navic jnt hand,timept

C

Collected at CRF.

MULTD char JSN mult navic jnt hand,timept

D

Collected at CRF.

CAPA char JSN Cap. Nav. Jnt. hand,timept

A

Collected at CRF.

CAPB char JSN Cap. Nav. Jnt. hand,timept

B

Collected at CRF.

CAPC char JSN Cap. Nav. Jnt. hand,timept

C

Collected at CRF.

CAPD char JSN Cap. Nav. Jnt. hand,timept

D

Collected at CRF.

RADIOA char JSN radiocarpal jnt hand, time

A

Collected at CRF.

RADIOB char JSN radiocarpal jnt hand, time

B

Collected at CRF.




RADIOC char JSN radiocarpal jnt hand, time

C

Collected at CRF.

RADIOD char JSN radiocarpal jnt hand, time

D

Collected at CRF.

FADQA char Overall adeq. ind. feet,timept

A

Collected at CRF.

FADQA1 char IP adeq. ind. feet, timepoint A Collected at CRF.

FADQA2 char MTP adeq. ind. feet, timepoint

A

Collected at CRF.

FADQB char Overall adeq. ind. feet,timept

B

Collected at CRF.

FADQB1 char IP adeq. ind. feet, timepoint B Collected at CRF.

FADQB2 char MTP adeq. ind. feet, timepoint

B

Collected at CRF.

FADQC char Overall adeq. ind. feet,timept

C

Collected at CRF.

FADQC1 char IP adeq. ind. feet, timepoint C Collected at CRF.

FADQC2 char MTP adeq. ind. feet, timepoint

C

Collected at CRF.

FADQD char Overall adeq. ind. feet,timept

D

Collected at CRF.

FADQD1 char IP adeq. ind. feet, timepoint D Collected at CRF.

FADQD2 char MTP adeq. ind. feet, timepoint

D

Collected at CRF.




FEROPIPA char Ero IP ind. feet, timepoint A Collected at CRF.

FEROPIPB char Ero IP ind. feet, timepoint B Collected at CRF.

FEROPIPC char Ero IP ind. feet, timepoint C Collected at CRF.

FEROPIPD char Ero IP ind. feet, timepoint D Collected at CRF.

FJSNPIPA char JSN IP ind. foot, timepoint A Collected at CRF.

FJSNPIPB char JSN IP ind. foot, timepoint B Collected at CRF.

FJSNPIPC char JSN IP ind. foot, timepoint C Collected at CRF.

FJSNPIPD char JSN IP ind. foot, timepoint D Collected at CRF.

IPA char Ero interph. jnt 1 foot,timept

A

Collected at CRF.

IPB char Ero interph. jnt 1 foot,timept

B

Collected at CRF.

IPC char Ero interph. jnt 1 foot,timept

C

Collected at CRF.

IPD char Ero interph. jnt 1 foot,timept

D

Collected at CRF.

FPA1 char Ero met. phal. jnt 1 foot,time

A

Collected at CRF.

FPB1 char Ero met. phal. jnt 1 foot,time

B

Collected at CRF.

FPC1 char Ero met. phal. jnt 1 foot,time

C

Collected at CRF.




FPD1 char Ero met. phal. jnt 1 foot,time

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.

FJA1 char JSN met. phal. jnt 1 foot,time

A

Collected at CRF.

FJB1 char JSN met. phal. jnt 1 foot,time

B

Collected at CRF.

FJC1 char JSN met. phal. jnt 1 foot,time

C

Collected at CRF.

FJD1 char JSN met. phal. jnt 1 foot,time

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.

DPAT_NO char Pat_no assigned for de-

identity

Randomly assigned Pat_no for de-identity


identity


IRDY num Relative Day of image reading If DATEOF and CONSDATE not missing then

perform below logic to calculate IRDY, If DATEOF

less than CONSDATE then (DATEOF - CONSDATE).

Else if DATEOF is greater than equal to CONSDATE

then (DATEOF- CONSDATE) +1.



1.4.24. Session2 – SESSION2

Dataset SESSION2

Creating program session2.sas

Description Session2


Sorted by DUNIQUEP



ID,BLINDCOD,DATEOF



identity



de-identity




ETIME char Entry time Collected at CRF.


SIDE char Body side Collected at CRF.

ADQA char Overall adeq. ind. hand,timept

A

Collected at CRF.




ADQA1 char PIP adeq. ind. hand, timepoint

A

Collected at CRF.

ADQA2 char MCP adeq. ind. hand,

timepoint A

Collected at CRF.

ADQA3 char Thumb adeq. ind. hand,

timepnt A

Collected at CRF.

ADQA4 char Wrist adeq. ind. hand, timepnt

A

Collected at CRF.

ADQB char Overall adeq. ind. hand,timept

B

Collected at CRF.

ADQB1 char PIP adeq. ind. hand, timepoint

B

Collected at CRF.

ADQB2 char MCP adeq. ind. hand,

timepoint B

Collected at CRF.

ADQB3 char Thumb adeq. ind. hand,

timepnt B

Collected at CRF.

ADQB4 char Wrist adeq. ind. hand, timepnt

B

Collected at CRF.

ADQC char Overall adeq. ind. hand,timept

C

Collected at CRF.

ADQC1 char PIP adeq. ind. hand, timepoint

C

Collected at CRF.

ADQC2 char MCP adeq. ind. hand,

timepoint C

Collected at CRF.




ADQC3 char Thumb adeq. ind. hand,

timepnt C

Collected at CRF.

ADQC4 char Wrist adeq. ind. hand, timepnt

C

Collected at CRF.

ADQD char Overall adeq. ind. hand,timept

D

Collected at CRF.

ADQD1 char PIP adeq. ind. hand, timepoint

D

Collected at CRF.

ADQD2 char MCP adeq. ind. hand,

timepoint D

Collected at CRF.

ADQD3 char Thumb adeq. ind. hand,

timepnt D

Collected at CRF.

ADQD4 char Wrist adeq. ind. hand, timepnt

D

Collected at CRF.

EROPIPA char Ero PIP ind. hand, timepoint A Collected at CRF.

EROPIPB char Ero PIP ind. hand, timepoint B Collected at CRF.

EROPIPC char Ero PIP ind. hand, timepoint C Collected at CRF.

EROPIPD char Ero PIP ind. hand, timepoint D Collected at CRF.

JSNPIPA char JSN PIP indicator hand, timept

A

Collected at CRF.

JSNPIPB char JSN PIP indicator hand, timept

B

Collected at CRF.

JSNPIPC char JSN PIP indicator hand, timept

C

Collected at CRF.




JSNPIPD char JSN PIP indicator hand, timept

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.

EROMCPA char Ero MCP ind. hand, timepoint

A

Collected at CRF.

EROMCPB char Ero MCP ind. hand, timepoint

B

Collected at CRF.

EROMCPC char Ero MCP ind. hand, timepoint

C

Collected at CRF.




EROMCPD char Ero MCP ind. hand, timepoint

D

Collected at CRF.

JSNMCPA char JSN MCP indicator hand,

timept A

Collected at CRF.

JSNMCPB char JSN MCP indicator hand,

timept B

Collected at CRF.

JSNMCPC char JSN MCP indicator hand,

timept C

Collected at CRF.

JSNMCPD char JSN MCP indicator hand,

timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.





hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.





hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.


hand,timept D

Collected at CRF.


hand,timept A

Collected at CRF.


hand,timept B

Collected at CRF.


hand,timept C

Collected at CRF.





hand,timept D

Collected at CRF.

EROWRIA char Ero Wrist ind. hand, timepoint

A

Collected at CRF.

EROWRIB char Ero Wrist ind. hand, timepoint

B

Collected at CRF.

EROWRIC char Ero Wrist ind. hand, timepoint

C

Collected at CRF.

EROWRID char Ero Wrist ind. hand, timepoint

D

Collected at CRF.

JSNWRIA char JSN Wrist indicator hand, time

A

Collected at CRF.

JSNWRIB char JSN Wrist indicator hand, time

B

Collected at CRF.

JSNWRIC char JSN Wrist indicator hand, time

C

Collected at CRF.

JSNWRID char JSN Wrist indicator hand, time

D

Collected at CRF.

BASEA char Metacarpal base (1),

timepoint A

Collected at CRF.

BASEB char Metacarpal base (1),

timepoint B

Collected at CRF.

BASEC char Metacarpal base (1),

timepoint C

Collected at CRF.




BASED char Metacarpal base (1),

timepoint D

Collected at CRF.

BONESA char Ero Multangulars hand,

timepnt A

Collected at CRF.

BONESB char Ero Multangulars hand,

timepnt B

Collected at CRF.

BONESC char Ero Multangulars hand,

timepnt C

Collected at CRF.

BONESD char Ero Multangulars hand,

timepnt D

Collected at CRF.

NAVA char Ero navic hand, timepoint A Collected at CRF.

NAVB char Ero navic hand, timepoint B Collected at CRF.

NAVC char Ero navic hand, timepoint C Collected at CRF.

NAVD char Ero navic hand, timepoint D Collected at CRF.

LUNA char Ero lunate hand, timepoint A Collected at CRF.

LUNB char Ero lunate hand, timepoint B Collected at CRF.

LUNC char Ero lunate hand, timepoint C Collected at CRF.

LUND char Ero lunate hand, timepoint D Collected at CRF.

RADIUSA char Ero radius hand, timepoint A Collected at CRF.

RADIUSB char Ero radius hand, timepoint B Collected at CRF.

RADIUSC char Ero radius hand, timepoint C Collected at CRF.

RADIUSD char Ero radius hand, timepoint D Collected at CRF.




ULNAA char Ero Ulna hand, timepoint A Collected at CRF.

ULNAB char Ero Ulna hand, timepoint B Collected at CRF.

ULNAC char Ero Ulna hand, timepoint C Collected at CRF.

ULNAD char Ero Ulna hand, timepoint D Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.





C

Collected at CRF.


D

Collected at CRF.

MULTA char JSN mult navic jnt hand,timept

A

Collected at CRF.

MULTB char JSN mult navic jnt hand,timept

B

Collected at CRF.

MULTC char JSN mult navic jnt hand,timept

C

Collected at CRF.

MULTD char JSN mult navic jnt hand,timept

D

Collected at CRF.

CAPA char JSN Cap. Nav. Jnt. hand,timept

A

Collected at CRF.

CAPB char JSN Cap. Nav. Jnt. hand,timept

B

Collected at CRF.

CAPC char JSN Cap. Nav. Jnt. hand,timept

C

Collected at CRF.

CAPD char JSN Cap. Nav. Jnt. hand,timept

D

Collected at CRF.

RADIOA char JSN radiocarpal jnt hand, time

A

Collected at CRF.

RADIOB char JSN radiocarpal jnt hand, time

B

Collected at CRF.




RADIOC char JSN radiocarpal jnt hand, time

C

Collected at CRF.

RADIOD char JSN radiocarpal jnt hand, time

D

Collected at CRF.

FADQA char Overall adeq. ind. feet,timept

A

Collected at CRF.

FADQA1 char IP adeq. ind. feet, timepoint A Collected at CRF.

FADQA2 char MTP adeq. ind. feet, timepoint

A

Collected at CRF.

FADQB char Overall adeq. ind. feet,timept

B

Collected at CRF.

FADQB1 char IP adeq. ind. feet, timepoint B Collected at CRF.

FADQB2 char MTP adeq. ind. feet, timepoint

B

Collected at CRF.

FADQC char Overall adeq. ind. feet,timept

C

Collected at CRF.

FADQC1 char IP adeq. ind. feet, timepoint C Collected at CRF.

FADQC2 char MTP adeq. ind. feet, timepoint

C

Collected at CRF.

FADQD char Overall adeq. ind. feet,timept

D

Collected at CRF.

FADQD1 char IP adeq. ind. feet, timepoint D Collected at CRF.

FADQD2 char MTP adeq. ind. feet, timepoint

D

Collected at CRF.




FEROPIPA char Ero IP ind. feet, timepoint A Collected at CRF.

FEROPIPB char Ero IP ind. feet, timepoint B Collected at CRF.

FEROPIPC char Ero IP ind. feet, timepoint C Collected at CRF.

FEROPIPD char Ero IP ind. feet, timepoint D Collected at CRF.

FJSNPIPA char JSN IP ind. foot, timepoint A Collected at CRF.

FJSNPIPB char JSN IP ind. foot, timepoint B Collected at CRF.

FJSNPIPC char JSN IP ind. foot, timepoint C Collected at CRF.

FJSNPIPD char JSN IP ind. foot, timepoint D Collected at CRF.

IPA char Ero interph. jnt 1 foot,timept

A

Collected at CRF.

IPB char Ero interph. jnt 1 foot,timept

B

Collected at CRF.

IPC char Ero interph. jnt 1 foot,timept

C

Collected at CRF.

IPD char Ero interph. jnt 1 foot,timept

D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.


D

Collected at CRF.


A

Collected at CRF.


B

Collected at CRF.


C

Collected at CRF.





D

Collected at CRF.


identity



identity









1.4.25. Thumbda1– THUMBDA1

Dataset THUMBDA1

Creating program thumbda1.sas

Description Thumbda1


Sorted by DUNIQUEP



ID,BLINDCOD,DATEOF



identity



de-identity






EROTHUA char Ero. ind for thumb,hand

timept A

Collected at CRF.




EROTHUB char Ero. ind for thumb,hand

timept B

Collected at CRF.

EROTHUC char Ero. ind for thumb,hand

timept C

Collected at CRF.

EROTHUD char Ero. ind for thumb,hand

timept D

Collected at CRF.

IPTHUA1 char Ero interph. jnt 1 hand timept

A

Collected at CRF.

IPTHUB1 char Ero interph. jnt 1 hand timept

B

Collected at CRF.

IPTHUC1 char Ero interph. jnt 1 hand timept

C

Collected at CRF.

IPTHUD1 char Ero interph. jnt 1 hand timept

D

Collected at CRF.

MA1 char Ero metacarp jnt 1 hand

timept A

Collected at CRF.

MB1 char Ero metacarp jnt 1 hand

timept B

Collected at CRF.

MC1 char Ero metacarp jnt 1 hand

timept C

Collected at CRF.

MD1 char Ero metacarp jnt 1 hand

timept D

Collected at CRF.

JSNA1 char JSN metacarp jnt 1 hand

timept A

Collected at CRF.




JSNB1 char JSN metacarp jnt 1 hand

timept B

Collected at CRF.

JSNC1 char JSN metacarp jnt 1 hand

timept C

Collected at CRF.

JSND1 char JSN metacarp jnt 1 hand

timept D

Collected at CRF.


identity



identity









1.4.26. Thumbda2– THUMBDA2

Dataset THUMBDA2

Creating program thumbda2.sas

Description Thumbda2


Sorted by DUNIQUEP



ID,BLINDCOD,DATEOF



identity



de-identity






EROTHUA char Ero. ind for thumb,hand

timept A

Collected at CRF.




EROTHUB char Ero. ind for thumb,hand

timept B

Collected at CRF.

EROTHUC char Ero. ind for thumb,hand

timept C

Collected at CRF.

EROTHUD char Ero. ind for thumb,hand

timept D

Collected at CRF.

IPTHUA1 char Ero interph. jnt 1 hand timept

A

Collected at CRF.

IPTHUB1 char Ero interph. jnt 1 hand timept

B

Collected at CRF.

IPTHUC1 char Ero interph. jnt 1 hand timept

C

Collected at CRF.

IPTHUD1 char Ero interph. jnt 1 hand timept

D

Collected at CRF.

MA1 char Ero metacarp jnt 1 hand

timept A

Collected at CRF.

MB1 char Ero metacarp jnt 1 hand

timept B

Collected at CRF.

MC1 char Ero metacarp jnt 1 hand

timept C

Collected at CRF.

MD1 char Ero metacarp jnt 1 hand

timept D

Collected at CRF.

JSNA1 char JSN metacarp jnt 1 hand

timept A

Collected at CRF.




JSNB1 char JSN metacarp jnt 1 hand

timept B

Collected at CRF.

JSNC1 char JSN metacarp jnt 1 hand

timept C

Collected at CRF.

JSND1 char JSN metacarp jnt 1 hand

timept D

Collected at CRF.


identity



identity









1.4.27. Visits – VISITS

Dataset VISITS

Creating program visits.sas

Description Visits





missing values:

PAGE,PAGE_SEQ,PAGE_SEC,MONTH,DAY,YEAR,HOUR,MINUTE,DATE_COL,

TIME_COL,DERIV_DT,TYPE_VIS,RSN_SPEC


DUNIQUEP char Protocol, Site, and Patient

numbers in s



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.


identity






de-identity


NOT_COMP char Indicates patient visit not

completed

Collected at CRF.

REASONND char Code for reason visit was not

performed

Collected at CRF.


collection







item val(s)








1.4.28. Chest X-Ray – XRAY

Dataset XRAY

Creating program xray.sas

Description Chest X-Ray





missing values:


ME_COL,DERIV_DT,CHEST_ND,CH_DATE,CH_TIME,CH_MONTH,CH_DAY,CH_

YEAR,CH_HOUR,CH_MIN,QUADRANT,HF_ND,HF_DATE,HF_MONTH,HF_DAY,

HF_YEAR,KNEE_DT,KNEE_MON,KNEE_DAY,KNEE_YR



identity



for chronol

Collected at CRF.




from Unique_pat

Collected at CRF.





identity



de-identity


CH_RSULT char Indicates chest x-ray was

normal or abno

Collected at CRF.

CH_DATDY num Relative Derived day of chest

x-ray

If CH_DATE and CONSDATE not missing then

perform below logic to calculate ,If CH_DATE less

than CONSDATE then (CH_DATE - CONSDATE).Else

if CH_DATE is greater than equal to CONSDATE

then (CH_DATE- CONSDATE) +1.


collection







item val(s)






HF_DATDY num Relative Der day of hands and

feet x-ray

If HF_DATE and CONSDATE not missing then

perform below logic to calculate ,If HF_DATE less

than CONSDATE then (HF_DATE - CONSDATE).Else

if HF_DATE is greater than equal to CONSDATE

then (HF_DATE- CONSDATE) +1.

Documents

Infliximab - yoda.yale.edu · C O N F I D E N T I A L P a g e 1 | 111 Clinical Development Infliximab C0168T22 Anonymisation Data Derivation Specification Document