L4C_RA0091

Sponsor: Biogen Drug: Natalizumab

In Development Get approval Retire 2 Start watching

TSPARMCD	TSPARM	TSVAL	TSVALNF	TSVALCD	TSVCDREF	TSVCDVER
ACTSUB	Actual Number of Subjects
ADAPT	Adaptive Design				CDISC
ADDON	Added on to Existing Treatments	Y		C49488	CDISC	2011-06-10
AGEMAX	Planned Maximum Age of Subjects		PINF		ISO 21090
AGEMIN	Planned Minimum Age of Subjects	P18M			ISO 8601
AGESPAN	Age Span
COMPTRT	Comparative Treatment Name
CRMDUR	Confirmed Response Minimum Duration				ISO 8601
CURTRT	Current Therapy or Treatment				SNOMED
DCUTDESC	Data Cutoff Description
DCUTDTC	Data Cutoff Date				ISO 8601
DOSE	Dose per Administration
DOSFRQ	Dosing Frequency
DOSU	Dose Units				UNII
FCNTRY	Planned Country of Investigational Sites				ISO 3166
HLTSUBJI	Healthy Subject Indicator				CDISC
INDIC	Trial Indication				SNOMED
INTMODEL	Intervention Model				CDISC
INTTYPE	Intervention Type				CDISC
LENGTH	Trial Length	P3M			ISO 8601
NARMS	Planned Number of Arms
OBJPRIM	Trial Primary Objective
OBJSEC	Trial Secondary Objective
OUTMSEXP	Exploratory Outcome Measure
OUTMSPRI	Primary Outcome Measure
OUTMSSEC	Secondary Outcome Measure
PCLAS	Pharmacological Class of Invest. Therapy	Biguanide		N0000175565	NDF-RT
PLANSUB	Planned Number of Subjects; Planned Enrollment; Target Enrollment; Anticipated Enrollment	300
RANDOM	Trial is Randomized	Y		C49488	CDISC	2014-03-28
RANDQT	Randomization Quotient
REGID	Registry Identifier	NCT00604695		NCT00604695	CT.GOV
ROUTE	Route of Administration				CDISC
SDMDUR	Stable Disease Minimum Duration				ISO 8601
SENDTC	Study End Date				ISO 8601
SEXPOP	Sex of Participants	BOTH		C49636	CDISC	2011-06-10
SPONSOR	Clinical Study Sponsor; Study Sponsor; Sponsor	MERCK Kommandit gesellschaft auf Aktien		342249299	DUNS
SSTDTC	Study Start Date				ISO 8601
STOPRULE	Study Stop Rules	INTERIM ANALYSIS FOR FUTILITY
STYPE	Study Type				CDISC
TBLIND	Trial Blinding Schema	DOUBLE BLIND		C15228	CDISC	2011-06-10
TCNTRL	Control Type	PLACEBO		C49648	CDISC	2011-06-10
TDIGRP	Diagnosis Group	Neurofibromatosis Syndrome (Disorder)		1913305	SNOMED
TINDTP	Trial Indication Type	TREATMENT		C49656	CDISC	2011-06-10
TITLE	Trial Title
TPHASE	Trial Phase Classification				CDISC
TRT	Investigational Therapy or Treatment	METFORMIN		9100L32L2N	UNII
TTYPE	Trial Type				CDISC

	Screen	1st Treatment	1st Rest	2nd Treatment	2nd Rest	3rd Treatment	Follow up
P-5-10	Screen	Placebo	Rest	5 mg	Rest	10 mg	Follow up
5-P-10	Screen	5 mg	Rest	Placebo	Rest	10 mg	Follow up
5-10-P	Screen	5 mg	Rest	10 mg	Rest	Placebo	Follow up

	Amnex Common	Screening SCREENING	Visit 1 (Day 1 Baesline) V1	Visit 2 (Week 26) V2	Visit 3 (Week 52) V3	Visit 4 (Week 78) V4	Visit 5 (Week 104) V5	Visit 6 (Week 130) V6	Visit 7 (Week 156) V7	Withdrawal Visit WITHDRAWN	Visit SFU (Safety Follow-Up Visit) FOLLOWUP	Unscheduled Unscheduled
Scheduling			7 (4 to 10) days after Screening	26 weeks after Visit 1	52 weeks after Visit 1	78 weeks after Visit 1	104 weeks after Visit 1	130 weeks after Visit 1	156 weeks after Visit 1
Epoch	Screen	Screen	1st Treatment	1st Treatment	1st Rest	2nd Treatment	2nd Rest	3rd Treatment	3rd Treatment	Follow up	Follow up
Publish Type	Screened	Screened	Enrolled	Enrolled	Enrolled	Enrolled	Enrolled	Enrolled	Enrolled	Discontinued	Discontinued	Unscheduled
Screened Scr
Enrolled Enroll
Failed Fail
Discontinued Disc
Completed Comp
Concomitant Medical Procedure(s) PROC1P01
Prior and Concomitant Medications Basic
Demography DM3P01
Eligibility Criteria IECRF3P01
Procedure History PH1P01
Medical History MH1P01
Vital Signs for Safety VSPSafetyCCM
Weight WT1P01
Physical Examination - Screening PEBL1P01
Chest X-ray CHESTXR1P01
Laboratory Tests LAB1P03
Urine Pregnancy Test LBUPP03
CRP / ESR Result CRPESR1P02
Tuberculosis Test Results (RA) TBTR2P02
Tuberculosis Test Results, TB Gold (RA) TBTR3P02
Tuberculosis Test Results, Diaskin (RA) TBTR4P02
First Medication Administration (Cimzia) NISFMA2P02
Physical Examination PE1P01
Harvey-Bradshaw Index (HBI)(Crohns) HB1P01
Assessment of Joint Tenderness Pain Swelling RAJOINT3P01
Physician Global Assessment of Disease Activity RAPHADVAS1P01
Patient Assessment of Arthritis Pain RAAPVAS1P01
Patient Global Assessment of Disease Activity RAPAAVASP02
HAQ-DI - Disability Index (RA) HAQDI1P01
Medication Administration (Cimzia) NISMA3P01
Telephone Contact TCP01

Table 1a: Characteristics of the study participants at baseline

Header
Table Title	Table 1a. Characteristics of the study participants at baseline
Building Blocks	Characteristic	N (%) or Median (IQR) N=xxx
Named Block Freq ADSL.SEX	Female gender	xx (xx.x)
Named Block Freq ADSL.AGE	Age, years	xx (xx-xx)
Named Block Freq ADSL.MARISTAT	Marital status Married Divorced/separated/widowed Single	xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.EDUCLVL	Education (highest completed) Less than primary Primary school Secondary school Vocational school University	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.INCOME12	Estimated monthly income (Kenyan Shillings) < 5,000 >= 5,000	xx (xx.x) xx (xx.x)
Named Block Freq ADSL.HOUSEHOLDMEM	Number of household residents	xx (xx-xx)
Named Block Freq ADSL.HOUSEHOLDRMS	Number of rooms in residence	xx (xx-xx)
Named Block Freq ADSL.ETHNIC	Water source Piped or well water Environmental water source	xx (xx.x) xx (xx.x)
Named Block Freq ADSL.WATERSOURCE	Toilet type Flush toilet Pit latrine Bush	xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.FACILITIESTYPE	Bet net use	xx (xx.x)
Named Block Freq ADSL.BEDNETYN	Boil or purify drinking water	xx (xx.x)
Named Block Freq ADSL.PURIFYYN	Hospitalized in past three months	xx (xx.x)
Named Block Freq ADSL.HOSPITALIZEDYN	Screening CD4, cells/mm³	xx (xx-xx)
Named Block Freq ADSL.CD4CELLCNT	Enrollment CD4, cells/mm³	xx (xx-xx)

Footer

Basic Table Footnotes	Note: Source: , Dataset: ADSL, Program:

Table 1b: Characteristics of the study participants at baseline, by study arm

Header
Table Title	Table 1b. Characteristics of the study participants at baseline, by study arm
Building Blocks	Characteristic	Trt N (%) or Median (IQR) N=xxx
Named Block Freq ADSL.SEX	Female gender	xx (xx.x)
Named Block Freq ADSL.AGE	Age, years	xx (xx-xx)
Named Block Freq ADSL.MARISTAT	Marital status Married Divorced/separated/widowed Single	xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.EDUCLVL	Education (highest completed) Less than primary Primary school Secondary school Vocational school University	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.INCOME12	Estimated monthly income (Kenyan Shillings) < 5,000 >= 5,000	xx (xx.x) xx (xx.x)
Named Block Freq ADSL.HOUSEHOLDMEM	Number of household residents	xx (xx-xx)
Named Block Freq ADSL.HOUSEHOLDRMS	Number of rooms in residence	xx (xx-xx)
Named Block Freq ADSL.ETHNIC	Water source Piped or well water Environmental water source	xx (xx.x) xx (xx.x)
Named Block Freq ADSL.WATERSOURCE	Toilet type Flush toilet Pit latrine Bush	xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.FACILITIESTYPE	Bet net use	xx (xx.x)
Named Block Freq ADSL.BEDNETYN	Boil or purify drinking water	xx (xx.x)
Named Block Freq ADSL.PURIFYYN	Hospitalized in past three months	xx (xx.x)
Named Block Freq ADSL.HOSPITALIZEDYN	Screening CD4, cells/mm³	xx (xx-xx)
Named Block Freq ADSL.CD4CELLCNT	Enrollment CD4, cells/mm³	xx (xx-xx)

Footer

Basic Table Footnotes	Note: Source: , Dataset: ADSL, Program:

Table 2a: Study retention

Header
Table Title	Table 2a. Study retention
Building Blocks		N (%) N=xxx
Named Block Freq ADQSADAS.VISITNUM	Attendance at study visit: * Month 0 (enrollment visit) Month 3 Month 6 Month 9 Month 12	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.LOSTFOLLOWUP	Lost to follow up:	xx (xx.x)
Named Block Freq ADSL.DTHFL	Deaths:	xx (xx.x)
Named Block Freq ADSL.DTWTHDR	Withdrawals:	xx (xx.x)

Footer

Basic Table Footnotes	Note: *Denominator for percentage is the number of participants expected to attend visit Source: , Dataset: ADSL, Program:

Table 2b. Study retention by study arm

Header
Table Title	Table 2b. Study retention by study arm
Building Blocks		Trt N (%) N=xxx
Named Block Freq ADQSADAS.VISITNUM	Attendance at study visit: * Month 0 (enrollment visit) Month 3 Month 6 Month 9 Month 12	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)
Named Block Freq ADSL.LOSTFOLLOWUP	Lost to follow up:	xx (xx.x)
Named Block Freq ADSL.DTHFL	Deaths:	xx (xx.x)
Named Block Freq ADSL.DTWTHDR	Withdrawals:	xx (xx.x)

Footer

Basic Table Footnotes	Note: *Denominator for percentage is the number of participants expected to attend visit Source: , Dataset: ADSL, Program:

Table 14-2.1.1: Baseline Demographic Characteristics

Header
Table Title	Table 14-2.1.1: Baseline Demographic Characteristics (Primary Analysis Set)
Building Blocks		Trt (N=xxx) n (%)	Overall (N=xxx) n (%)	p-value
Named Block Freq ADSL.SEX	Sex [n (%)] Male Female	xx (xx.x) xx (xx.x)	xx (xx.x) xx (xx.x)	x.xxx
Named Block Freq ADSL.RACE	Race [n (%)] American Indian or Alaska Native Asian Black or African American White Other	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)	xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x)	x.xxx
Named Block Freq ADSL.ETHNIC	Ethnicity [n (%)] Hispanic or Latino Not Hispanic or Latino	xx (xx.x) xx (xx.x)	xx (xx.x) xx (xx.x)	x.xxx
Named Block Sum ADSL.AGE	Age (years) n Mean (SD) Median Min, Max	xxx xx (xx.x) xx.x xx, xx	xxx xx (xx.x) xx.x xx, xx	x.xxx
Named Block Sum ADSL.AGE	Age - n(%) < 65 years >= 65 years	xx (xx.x) xx (xx.x)	xx (xx.x) xx (xx.x)

P-Value
Footer

Basic Table Footnotes	Note 1: Number of subjects randomized and dosed in the safety analysis set Note 2: Percentages based on number of subjects of each sex Note 3: Age is derived as informed consent date - date of birth / 365.25 Source: Listing 16.1.3.1, Dataset: ADSL, ADAE, Program: T_DEOM1.sas

Table 14-2.1.2: Demographic Characteristics 2

Header
Table Title	Table 14-2.1.2: Demographic Characteristics (ITT) Population
Building Blocks		Trt (N=xxx) n (%)
Named Block Freq ADSL.SEX	Sex [n (%)] Male Female	xx (xx.x) xx (xx.x)
Named Block Sum ADSL.AGE	Age (years) n Mean (SD) Median Min, Max	xxx xx (xx.x) xx.x xx, xx

Footer
Basic Table Footnotes	Note 1: Age is derived as informed consent date - date of birth / 365.25 Source: Listing 16.1.3.1, Dataset: ADSL, Program: T_DEOM1.sas

Table 14-2.1.3: New Table 1

Header
Table Title		Table 14-2.1.3: New Table 1
Building Blocks

Footer
Basic Table Footnotes		Note 1: <Derivation information> Source: <?>, Dataset: <?>, Program: <?>

SIM Properties

Version:1.0

Protocol Title:
A multi-center observational study to evaluate the safety and effectiveness of Cimzia (Certolizumab Peo) in adult...

Study Indication:
Rheumatoid Arthritis (RA) and Crohn's Disease (CD)

Study Phase:Phase IV - NIS

...and 0/47 in Trial Summary TS

History and Lifecycle

Modified:4/3/2015 6:27 PM

Created:4/2/2015 12:01 PM

Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist	Origin	Derivation / Comment
ADaM Derivation Rules
ADVS	VSTEST	Vital Signs Test Name	text	$40	ALL		Predecessor	VS.VSTEST
ADVS	VSTESTCD	Vital Signs Test Short Name	text	$40	ALL		Predecessor	VS.VSTESTCD
ADVS	VSORRES	Results in Original Units	text	$300	ALL		Predecessor	VS.VSPRRES
ADVS	VSPOS	Position of Subject	text	$40	ALL		Predecessor	VS.VSPOS
ADVS	VISITNUM	Visit Number	text	$40	ALL		Predecessor	VS.VISITNUM
ADVS	VSDTC	Date/Time of Measurement	text	$40	ALL		Predecessor	VS.VSDTC
ADVS	PARAM	Parameter	text	$40	DEFAULT	Diastolic Blood Pressure (mmHg) Systolic Blood Pressure (mmHg) Heart Rate (BEATS/MIN) Weight (kg) Height (cm)	Derived	Test (VS.VSTEST) and unit (VS.VSTESTU) as one string
ADVS	PARAM	Parameter	text	$40	BMI	BMI (kg/m^2)	Assigned	Additional rows for calculated BMI
ADVS	PARAMCD	Parameter Code	text	$40	DEFAULT	DIABP SYSBP HR WEIGHT HEIGHT	Predecessor	Test code (VS.VSTESTCD)
ADVS	PARAMCD	Parameter Code	text	$40	BMI	BMI	Assigned	Additional rows for calculated BMI
SDTM Derivation Rules
Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist	Origin	Derivation / Comment
VS	VSTEST	Vital Signs Test Name	text	$40	ALL		Derived	If CRF field is DIABP, set to "Diastolic Blood Pressure"
VS	VSTESTCD	Vital Signs Test Short Name	text	$8	ALL		Derived	If CRF field is DIABP, set to "DIABP"
VS	VSORRES	Results in Original Units	text	$200	ALL		Derived	Value of DIABP CRF field
VS	VSORRESU	Units	text	$40	ALL		Derived	If CRF field is DIABP, set to "mmHg"
VS	VSPOS	Position of Subject	text	$40	ALL		Derived	If CRF field is DIABP, set to "Sitting"
VS	VISITNUM	Visit Number	float	8	ALL		Derived	Study visit number
VS	VSDTC	Date/Time of Measurement	datetime	$90	ALL		Derived	Study visit date/time (dd MMM yyyy)
Form Variables
Dataset Name	Variable Name	Variable Label	Variable Type	Variable Format	Parameter Identifier	Codelist
VS	DIABP	Sitting Diastolic Blood Pressure	Char	$3	ALL

L4C_RA0091

Table 1a: Characteristics of the study participants at baseline

Table 1b: Characteristics of the study participants at baseline, by study arm

Table 2a: Study retention

Table 2b. Study retention by study arm

Table 14-2.1.1: Baseline Demographic Characteristics

Table 14-2.1.2: Demographic Characteristics 2

Table 14-2.1.3: New Table 1

SIM Properties

History and Lifecycle

Pull from standards or similar studies

34 matches

Pull from available TFL building blocks

16 available

ADaM Derivation Rules

SDTM Derivation Rules

Form Variables

6 matches

	<trt> (n (%))
<param> (<unit>) n Number Missing Mean (SD) Min, Max Median 25th, 75th Percentile	xx x xx.x (xx.xx) xx, xx xx.x xx.x, xx.x

	<trt> (n (%))
<param> (<unit>) n Number Missing Mean (SD) GMedian Min, Max	xx x xx.x (xx.xx) xx.x (xx.xx) xx, xx

	<trt> (N=[trtN]) (n (%))
<SOC> [PT-list]	xx (xx.x)

L4C_RA0091

Table 1a: Characteristics of the study participants at baseline

Table 1b: Characteristics of the study participants at baseline, by study arm

Table 2a: Study retention

Table 2b. Study retention by study arm

Table 14-2.1.1: Baseline Demographic Characteristics

Table 14-2.1.2: Demographic Characteristics 2

Table 14-2.1.3: New Table 1

SIM Properties

History and Lifecycle

Pull from standards or similar studies

34 matches

Pull from available TFL building blocks

16 available

SIM Properties

Workbook Tab Properties

Import ODM XML Files or Excel Spreadsheets

Get Approval

Mapping for variable Diastolic Blood Pressure in Vital Signs map as: Vital Sign Transformation mapping template Form variables to SDTM choose

ADaM Derivation Rules

SDTM Derivation Rules

Form Variables

Edit Value Set:

Find a code system

6 matches

Mapping for variable Diastolic Blood Pressure in Vital Signs
map as: Vital Sign Transformation mapping template Form variables to SDTM choose