L4C_RA0091

Sponsor: Biogen
Therapeutic Area: Autoimmune
Drug: Natalizumab

Awaiting Review Cancel Request Retire 2 Start watching

Adverse Event
AE1001

AESTDTC

Start Date/Time of Adverse Event

Char

AESTDAT

What is the date the adverse event started?

Char (dd-MON-yyyy)

AESTTIM

At what time did the adverse event start?

Char

DM_DYN_02 Restricted to a value range with this description of the algorithm

MH.MHDECOD

Diagnosis

Char

MHTERM, MHCAT

Diagnosis

Char ($200)

MHTERM="Alzheimers", MHCAT="PRIMARY DIAGNOSIS"

Primary Diagnosis

Char

MHTERM, MHCAT

Diagnosed Alzheimer's

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

Char

MHOSDTC

Onset of Symptoms Date

Char (dd-MON-yyyy)

AETOXGR

Standard Toxicity Grade

Char

AETOXGR

What is the toxicity grade of the adverse event?

TOXGRV4

0 Absent Adverse Event
1 Mild Adverse Event
2 Moderate Adverse Event
3 Severe Adverse Event
4 Life Threatening Adverse Event
5 Death Related to Adverse Event

MH.MHDECOD

Diagnosis

Char

MHTERM, MHCAT

Diagnosis

Char ($200)

DM_DYN_02 Restricted to a value range with this description of the algorithm

Weight*
WHT1001

AESTDTC

Start Date/Time of Adverse Event

Char

AESTDAT

What is the date the adverse event started?

Char (dd-MON-yyyy)

AESTTIM

At what time did the adverse event start?

Char

AESTDTC

Start Date/Time of Adverse Event

Char

AESTDAT

What is the date the adverse event started?

Char (dd-MON-yyyy)

AESTTIM

At what time did the adverse event start?

Char

	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

Seq.	Observation Class	Domain Prefix	Variable Name	Variable Label	Type	Controlled Terms of Format	Core	Definition
1	General information	AEYN	AEYN	Any AEs?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any AEs were experienced during the study. This provides verification that all other fields on the CRF were deliberately left blank.
2	Details	AE	AETERM	Adverse Event	text		Req	Verbatim (i.e., investigator-reported term) description of the adverse event.
3	Details	AE	AESTDAT	Start Date	partialDate		Req	Date when the adverse event started.
4	Details	AE	AEENDAT	End Date	partialDate		Req	Date when the adverse event resolved.
5	Details	AE	AEONGO	Ongoing?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates AE is ongoing when no End Date is provided.
6	Details	AE	AESEV	Severity	text	CL.AESEV_2011-10-24	Req	Description of the severity of the adverse event.
7	Details	AE	AESER	Serious	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates whether or not the adverse event is determined to be -serious�?� based on what is defined in the protocol.
8	Details	AE	AESCONG	Congenital Anomaly or Birth Defect	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event was associated with a congenital anomaly or birth defect.
9	Details	AE	AESDISAB	Significant Disability	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event was associated with a persistent or significant disability or incapacity.
10	Details	AE	AESDTH	Death	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event resulted in death.
11	Details	AE	AESHOSP	Hospitalization	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event resulted in an initial or prolonged hospitalization for the subject.
12	Details	AE	AESLIFE	Life threatening	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event was life threatening.
13	Details	AE	AESMIE	Other Medically Important Event	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates if a -serious�?� adverse event is associated with other serious or important medical events.
14	Details	AE	AEREL	Relationship to Study Treatment	text	CL.AEREL_2011-10-24	Req	Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.
15	Details	AE	AEACN	Action Taken with Study Treatment	text	CL.ACN_2011-10-24	Req	Changes made to the study treatment in response to the adverse event.
16	Details	AE	AEACNOTH	Other Action Taken	text		Req	Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.
17	Details	AE	AEOUT	Outcome	text	CL.OUT_2011-10-24	Req	Description of the subject-s status associated with an event.
18	Details	AE	AEDIS	Caused Study Discontinuation	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indication of whether the adverse event caused the subject to discontinue from the study.
19	General information	CMYN	CMYN	Any meds?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question to aid in monitoring and data cleaning.
20	Details	CM	CMTRT	Medication or Therapy	text		Req	Verbatim drug name or therapy (include only therapies with data collection characteristics similar medications).
21	Details	CM	CMDOSE+CMDOSU	Dose	float		Req	The dose of medication taken per administration.
22	Details	CM	CMDOSFRQ	Frequency	text	CL.FREQ.SUBSET.CMDOSFRQ_2011-10-24	Req	How often the medication was taken (e.g., BID, PRN).
23	Details	CM	CMROUTE	Route	text	CL.ROUTE.SUBSET.CMROUTE_2011-10-24	Req	Identifies the route of administration of the drug.
24	Details	CM	CMSTDAT	Start Date	partialDate		Req	Date when the medication was first taken.
25	Details	CM	CMPRIOR	Taken Prior to Study?	text	CL.NY_SUB_Y_N_2011-10-24	Req	To determine if medications were taken prior to study start.
26	Details	CM	CMENDAT	End Date	partialDate		Req	Date that the subject stopped taking the medication or therapy.
27	Details	CM	CMONGO	Ongoing	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates medication or therapy is ongoing when no End Date is provided.
28	Demographics	DM	BRTHDAT	Birth Date	partialDate		Req	A subject-s date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day and Birth Time.
29	Demographics	DM	SEX	Sex	text	CL.SEX_2011-10-24	Req	The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female (NCI - CDISC Definition). {SEX} (See Section 2.2.)
30	Demographics	DM	ETHNIC	Ethnicity	text	CL.ETHNIC.SUBSET.ETHNIC_2011-10-24	Req	A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease (NCI - CDISC Definition). {ETHNIC} (See Section 2.2.)
31	Demographics	DM	SUPPDM.QNAM	Specify Other	text		Req	A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection needs to be added to those pre-printed values.
32	Demographics	DM	SUPPDM.QNAM	American Indian or Alaska Native	boolean		Req	An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).{RACE} (See Section 2.2.)
33	Demographics	DM	SUPPDM.QNAM	Asian	boolean		Req	An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).{RACE} (See Section 2.2.)
34	Demographics	DM	SUPPDM.QNAM	Black or African American	boolean		Req	An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).{RACE} (See Section 2.2.)
35	Demographics	DM	SUPPDM.QNAM	Native Hawaiian or Other Pacific Islander	boolean		Req	An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).{RACE} (See Section 2.2.)
36	Demographics	DM	SUPPDM.QNAM	White	boolean		Req	An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. Center for Disease Control).{RACE} (See Section 2.2.)
37	General information	MH	MHYN	Any medical history?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question to aid in monitoring and data cleaning. {NY} (See Section 2.2.)
38	Other	MH	MHTERM		text		Req	Verbatim or preprinted CRF term for the medical condition or event.
39	Other	MH	MHONGO	Ongoing	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates medical history event is ongoing when no End Date is provided.{NY} (See Section 2.2.)
40	Other	MH	MHCTRL	Controlled	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates that the disease/symptoms are under control at the time of data collection.
41	Other	MH	MHSTDAT	Start Date	partialDate		Req	Start date of Medical History event.
42	Other	MH	MHENDAT	End Date	partialDate		Req	End date of Medical History event.
43	General information	MH	MHDAT	Collection Date	partialDate		Req	The date on which the Medical History was taken.
44	High Blood Pressure	MH	MHOCCUR	High blood pressure	text	CL.NY_SUB_Y_N_2011-10-24	Req	A response to a pre-printed term used to indicate whether or not a medical condition has occurred.{NY} (See Section 2.2.)
45	High Blood Pressure	MH	HBP.MHSTDAT	Start Date	partialDate		Req	Start date of Medical History event.
46	High Blood Pressure	MH	HBP.MHENDAT	End Date	partialDate		Req	End date of Medical History event.
47	High Blood Pressure	MH	HBP.MHONGO	Ongoing	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indicates medical history event is ongoing when no End Date is provided.{NY} (See Section 2.2.)
48	Appendectomy	MH	MHOCCUR	Appendectomy	text	CL.NY_SUB_Y_N_2011-10-24	Req	A response to a pre-printed term used to indicate whether or not a medical condition has occurred.{NY} (See Section 2.2.)
49	Appendectomy	MH	APPENDECTOMY.MHSTDAT	Start Date	partialDate		Req	Start date of Medical History event.
50	General information	VS	VSPERF	Vital signs collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
51	Date of measurement	VS	VSDAT	Date	partialDate		Req	Date of measurements
52	Height	VS	HEIGHT.VSPERF	Height collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
53	Height	VS	VSORRES+VSORRESU	Height	float		Req	Result of the vital signs measurement as originally received or collected.
54	Height	VS	SUPPVS.QNAM	Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether vital sign result was clinically significant.
55	Weight	VS	WEIGHT.VSPERF	Weight collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
56	Weight	VS	VSORRES+VSORRESU	Weight	float		Req	Result of the vital signs measurement as originally received or collected.
57	Weight	VS	SUPPVS.QNAM	Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether vital sign result was clinically significant.
58	Blood pressure	VS	BP.VSPERF	BP collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
59	Blood pressure	VS	VSORRES+VSORRESU	Systolic	float		Req	Result of the vital signs measurement as originally received or collected.
60	Blood pressure	VS	VSORRES+VSORRESU	Diastolic	float		Req	Result of the vital signs measurement as originally received or collected.
61	Blood pressure	VS	VSLOC	BP Location	text	CL.LOC_BP_2011-10-24	Req	Location relevant to the collection of Vital Signs measurement. Example: LEFT ARM for blood pressure.{LOC) (See Section 2.2.)
62	Blood pressure	VS	VSPOS	BP Position	text	CL.VSPOSITION_2011-10-24	Req	Position of the subject during a measurement or examination. {POSITION} (See Section 2.2.)
63	Blood pressure	VS	SUPPVS.QNAM	BP Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether vital sign result was clinically significant.
64	Blood pressure	VS	BP.VSTIM	Time	partialTime		Req	Time of measurements.
65	Pulse	VS	PULSE.VSPERF	Pulse collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
66	Pulse	VS	VSORRES+VSORRESU	Pulse	float		Req	Result of the vital signs measurement as originally received or collected.
67	Pulse	VS	VSLOC	Pulse Location	text	CL.LOC.SUBSET.PULSE.VSLOC_2011-10-24	Req	Location relevant to the collection of Vital Signs measurement. Example: LEFT ARM for blood pressure.{LOC) (See Section 2.2.)
68	Pulse	VS	VSPOS	Pulse Position	text	CL.VSPOSITION_2011-10-24	Req	Position of the subject during a measurement or examination. {POSITION} (See Section 2.2.)
69	Pulse	VS	SUPPVS.QNAM	Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether vital sign result was clinically significant.
70	Temperature	VS	TEMP.VSPERF	Temperature collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
71	Temperature	VS	VSORRES+VSORRESU	Temperature	float		Req	Result of the vital signs measurement as originally received or collected.
72	Temperature	VS	VSLOC	Temperature Location	text	CL.LOC.SUBSET.TEMP.VSLOC_2011-10-24	Req	Location relevant to the collection of Vital Signs measurement. Example: LEFT ARM for blood pressure.{LOC) (See Section 2.2.)
73	Temperature	VS	SUPPVS.QNAM	Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether vital sign result was clinically significant.
74	Frame size	VS	FRMSIZE.VSPERF	Frame Size collected?	text	CL.NY_SUB_Y_N_2011-10-24	Req	General prompt question regarding whether or not any VS were collected during the study. This provides verification that all other fields on the CRF were deliberately left blank.{NY} (See Section 2.2.)
75	Frame size	VS	VSORRES+VSORRESU	Frame Size	text	CL.FRMSIZE_2011-10-24	Req	Result of the vital signs measurement as originally received or collected.
76	Substance use - Cigarettes	SU	TOBACCO.CIGARETTES.SUNCF	Usage	text	CL.SUNCF_2011-10-24	Req	Substance Use Occurrence.{NCF} See Section 2.2
77	Substance use - Cigarettes	SU	SUDOSTXT	Amount	text	CL.SUDOSTXT_CIGARETTES_2011-10-24	Req	Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc].
78	Substance use - Cigarettes	SU	TOBACCO.CIGARETTES.SUSTDAT	Start Date	partialDate		Req	Date substance use started.
79	Substance use - Cigarettes	SU	TOBACCO.CIGARETTES.SUENDAT	End date	partialDate		Req	Date substance use ended.
80	Substance use - Cigarettes	SU	TOBACCO.CIGARETTES.SUCDUR	Duration	durationDatetime		Req	The duration of the substance use.
81	Substance use - Cigars	SU	TOBACCO.CIGARS.SUNCF	Usage	text	CL.SUNCF_2011-10-24	Req	Substance Use Occurrence.{NCF} See Section 2.2
82	Substance use - Cigars	SU	SUDOSTXT	Amount	text	CL.SUDOSTXT_CIGARS_2011-10-24	Req	Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc].
83	Substance use - Cigars	SU	TOBACCO.CIGARS.SUSTDAT	Start Date	partialDate		Req	Date substance use started.
84	Substance use - Cigars	SU	TOBACCO.CIGARS.SUENDAT	End date	partialDate		Req	Date substance use ended.
85	Substance use - Cigars	SU	TOBACCO.CIGARS.SUCDUR	Duration	durationDatetime		Req	The duration of the substance use.
86	Substance use - Alcohol	SU	ALCOHOL.SUNCF	Usage	text	CL.SUNCF_2011-10-24	Req	Substance Use Occurrence.{NCF} See Section 2.2
87	Substance use - Alcohol	SU	SUDOSTXT	Amount Beer	float		Req	Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc].
88	Substance use - Alcohol	SU	SUDOSFRQ	Frequency Beer	text	CL.FREQ.SUBSET.ALCOHOL.BEER.SUDOSFRQ_2011-10-24	Req	Usually expressed as the number of uses consumed per a specific interval (e.g., PER DAY, PER WEEK, OCCASIONAL).
89	Substance use - Alcohol	SU	SUDOSTXT	Amount Wine	float		Req	Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc].
90	Substance use - Alcohol	SU	SUDOSFRQ	Frequency Wine	text	CL.FREQ.SUBSET.ALCOHOL.WINE.SUDOSFRQ_2011-10-24	Req	Usually expressed as the number of uses consumed per a specific interval (e.g., PER DAY, PER WEEK, OCCASIONAL).
91	Substance use - Alcohol	SU	SUDOSTXT	Amount Spirits	float		Req	Substance use consumption amounts or a range of consumption information collected in text form [e.g., 1-2 (packs), 8 (ounces), etc].
92	Substance use - Alcohol	SU	SUDOSFRQ	Frequency Spirits	text	CL.FREQ.SUBSET.ALCOHOL.SPIRITS.SUDOSFRQ_2011-10-24	Req	Usually expressed as the number of uses consumed per a specific interval (e.g., PER DAY, PER WEEK, OCCASIONAL).
93	Substance use - Alcohol	SU	ALCOHOL.SUSTDAT	Start Date	partialDate		Req	Date substance use started.
94	Substance use - Alcohol	SU	ALCOHOL.SUENDAT	End date	partialDate		Req	Date substance use ended.
95	Substance use - Alcohol	SU	SUDUR	Duration	durationDatetime		Req	The duration of the substance use.
96	General information	EG	EGSTAT	ECG Performed	text	CL.NY_SUB_Y_N_2011-10-24	Req	Status of whether or not ECG or a specific ECG test was done.{NY} (See Section 2.2.)
97	ECG Information (Central processing)	EG	EGREFID	Reference ID	text		Req	Identifier of the ECG (e.g. waveform number).
98	ECG Information (Local processing)	EG	EGMETHOD	Method	text	CL.EGMETHOD_2011-10-24	Req	Method used to measure ECG.{EGMETHOD} (See Section 2.2.)
99	ECG Information (Local processing)	EG	EGPOS	Subject Position	text	CL.POSITION.SUBSET.EGPOS_2011-10-24	Req	Position of the subject during the ECG measurement.{POSITION} (See Section 2.2.)
100	ECG Information (Local processing)	EG	EGDTC	ECG Date and Time	partialDatetime		Req	Date and Time of ECG.
101	ECG Results	EG	EGORRES+EGORRESU	Summary (Mean) Ventricular Rate	float		Req	Result of the measurement or finding as originally received or collected.
102	ECG Results	EG	SUPPEG.QNAM	Summary (Mean) Ventricular Rate Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
103	ECG Results	EG	EGORRES+EGORRESU	PR	float		Req	Result of the measurement or finding as originally received or collected.
104	ECG Results	EG	SUPPEG.QNAM	PR Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
105	ECG Results	EG	EGORRES+EGORRESU	QRS	float		Req	Result of the measurement or finding as originally received or collected.
106	ECG Results	EG	SUPPEG.QNAM	QRS Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
107	ECG Results	EG	EGORRES+EGORRESU	QT	float		Req	Result of the measurement or finding as originally received or collected.
108	ECG Results	EG	SUPPEG.QNAM	QT Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
109	ECG Results	EG	EGORRES+EGORRESU	QTc - Bazett's	float		Req	Result of the measurement or finding as originally received or collected.
110	ECG Results	EG	SUPPEG.QNAM	QTc - Bazett's Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
111	ECG Results	EG	EGORRES+EGORRESU	Interpretation	text		Req	Result of the measurement or finding as originally received or collected.
112	ECG Results	EG	SUPPEG.QNAM	Interpretation Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether ECG results were clinically significant.{NY} (See Section 2.2.)
113	LAB Information	LB	LBSTAT	Lab Status	text	CL.NY_SUB_Y_N_2011-10-24	Req	Status of whether or not lab specimen was collected or measurement performed.{NY} (See Section 2.2.)
114	LAB Information	LB	LBDTC	Collection Date and Time	partialDatetime		Req	Date and Time of specimen collection.
115	LAB Information	LB	FASTING.LBCOND	Fasting ?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Confirmation that the protocol defined condition imposed on the subject when testing (e.g., FASTING, HYDRATION, EXERCISE) was met.If collecting this as a Yes/No, use {NY}(See Section 2.2.)
116	LAB Information	LB	LBREFID	Accession Number	text		Req	Internal or external specimen identifier.
117	CBC LAB Abnormal Result	LB	LBTEST		text		Req	Verbatim name of the test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test. {LBTEST} (See Section 2.2.)
118	CBC LAB Results - Erythrocytes Distribution Width	LB	LBORRES	Result	text		Req	Result of the measurement or finding as originally received or collected.
119	CBC LAB Results - Platelet Count	LB	LBORRESU	Units	text	CL.LB_UNIT_x10E9/L_2011-10-24	Req	Original units in which the data were collected.
120	CBC LAB Results - Erythrocytes	LB	LBORRESU	Units	text	CL.LB_UNIT_x10E12/L_2011-10-24	Req	Original units in which the data were collected.
121	CBC LAB Results - Neutrophils	LB	LBORRESU	Units	text	CL.LB_UNIT_nmol/L_2011-10-24	Req	Original units in which the data were collected.
122	CBC LAB Results - Ery. Mean Corpuscular HB Concentration	LB	LBORRESU	Units	text	CL.LB_UNIT_mmol/L_2011-10-24	Req	Original units in which the data were collected.
123	CBC LAB Results - Ery. Mean Corpuscular Hemoglobin	LB	LBORRESU	Units	text	CL.LB_UNIT_fmol_2011-10-24	Req	Original units in which the data were collected.
124	CBC LAB Results - Erythrocytes Distribution Width	LB	LBORRESU	Units	text	CL.LB_UNIT_%_2011-10-24	Req	Original units in which the data were collected.
125	CBC LAB Results - Mean Platelet Volume	LB	LBORRESU	Units	text	CL.LB_UNIT_fL_2011-10-24	Req	Original units in which the data were collected.
126	CBC LAB Results - Erythrocytes Distribution Width	LB	LBORNRLO	Low Normal	text		Req	The lowest continuous numeric value of a given lab result expected in the population of interest.
127	CBC LAB Results - Erythrocytes Distribution Width	LB	LBORNRHI	High Normal	text		Req	The highest continuous numeric value of a given lab result expected in the population of interest.
128	CBC LAB Results - Erythrocytes Distribution Width	LB	LBNRIND	Abnormal	text	CL.NRIND_2011-10-24	Req	Reference Range Indicator Indicates where value falls with respect to reference range defined by high and low ranges.{NRIND} (See Section 2.2.)
129	CBC LAB Abnormal Result	LB	SUPPLB.QNAM	Clinically Significant	text	CL.NY_SUB_Y_N_2011-10-24	Req	Whether lab test results were clinically significant.
130	LAB Information	LB	LBNAM	Laboratory Name	text		Req	Name of lab analyzing specimen.
131	Subject Characteristics	SC	SCORRES+SCORRESU	Gestational Age at Birth	float		Req	The age (in weeks) of the newborn infant, counted from the woman's last menstrual period (LMP) or health status indicators/Clinical Estimate (CE).
132	Subject Characteristics	SC	SCORRES	Childbearing Potential	text	CL.NY_SUB_Y_N_2011-10-24	Req	Subject-s childbearing potential.
133	Subject Characteristics	SC	SCORRES	Education	text		Req	Education level achieved at start of study (Reference date).
134	Subject Characteristics	SC	SCORRES	Skin Classification	text	CL.SKINCLAS_2011-10-24	Req	A classification system used to categorize the sensitivity of a subject's skin to sunlight.
135	Subject Characteristics	SC	SCORRES	Marital Status	text	CL.MARISTAT_2011-10-24	Req	A demographic parameter indicating a person's current conjugal status.
136	End of Study	DS	ENDOFSTUDY.DSSTDAT	Completion or Discontinuation Date	date		Req	The date that the subject completed the study or portion of the study, or the date that the subject discontinued from the selected trial epoch.
137	End of Study	DS	ENDOFSTUDY.DSSTTIM	Completion or Discontinuation Time	time		Req	The time that the subject completed the study or portion of the study or the date that the subject discontinued.
138	End of Study	DS	DSDECOD	Status	text	CL.NCOMPLT_2011-10-24	Req	Describes whether a subject completed the study or a portion of a study (epoch) or the reason they did not complete.DSDECOD is the Standardized Disposition Term{NCOMPLT} (See Section 2.2.)
139	End of Study	DS	DSTERM	Specify Status	text		Req	Describes whether a subject completed the study or a portion of a study (epoch) or the reason they did not complete.DSDECOD is the Standardized Disposition Term{NCOMPLT} (See Section 2.2.)
140	General information	DA	DASTAT	DA Performed?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Status of whether or not drug accountability was done.{NY} (See Section 2.2.)
141	Study Treatment	DA	DADAT	Date (dispensed or returned)	date		Req	Date the study treatment was dispensed or returned
142	Study Treatment	DA	DAREFID	Treatment label ID	text		Req	Treatment label identifier (e.g. kit number, bottle label, vial identifier).
143	Study Treatment	DA	DATEST	Dispensed or returned	text	CL.DATEST_2011-10-24	Req	Verbatim name, corresponding to the topic variable, of the test or examination used to obtain the drug accountability assessment (e.g., dispensed, returned). {DATEST and DATESTCD} (See Section 2.2.)
144	Study Treatment	DA	DAORRES+DAORRESU	Amount	float		Req	Result of the Drug Accountability assessment as originally dispensed or returned (i.e., actual amount).
145	Study Treatment - Returned Amount	DA	RETAMT.DADAT	Date	date		Req	Date the study treatment was dispensed or returned
146	Study Treatment - Returned Amount	DA	DAREFID	Treatment label ID	text		Req	Treatment label identifier (e.g. kit number, bottle label, vial identifier).
147	Study Treatment - Returned	DA	DASTAT	DA Performed?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Status of whether or not drug accountability was done.{NY} (See Section 2.2.)
148	Study Treatment - Returned Amount	DA	DAORRES+DAORRESU	Amount	float		Req	Result of the Drug Accountability assessment as originally dispensed or returned (i.e., actual amount).
149	Study Treatment - Dispensed Amount	DA	DISPAMT.DADAT	Date	date		Req	Date the study treatment was dispensed or returned
150	Study Treatment - Dispensed Amount	DA	DAREFID	Treatment label ID	text		Req	Treatment label identifier (e.g. kit number, bottle label, vial identifier).
151	Study Treatment - Dispensed	DA	DASTAT	DA Performed?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Status of whether or not drug accountability was done.{NY} (See Section 2.2.)
152	Study Treatment - Dispensed Amount	DA	DAORRES+DAORRESU	Amount	float		Req	Result of the Drug Accountability assessment as originally dispensed or returned (i.e., actual amount).
153	Exposure	EX	EXSTDTC	Start Date and Time	datetime		Req	Start date and time of treatment.
154	Exposure	EX	EXENDTC	End Date and Time	datetime		Req	End date and time of treatment.
155	Exposure	EX	EXDSTXT	Dose	float		Req	Dose per administration.
156	Exposure	EX	EXLOT	Lot Number	text		Req	EXLOT = Lot Number of the EXTRT product.
157	Exposure	EX	EXTRT	Treatment Name	text		Req	Name of the study treatment or intervention given per single administration or during the -constant dosing interval�?� for the observation.
158	Exposure	EX	EXDOSADJ	Adjusted	text	CL.NY_SUB_Y_N_2011-10-24	Req	Confirmation of dose adjustment.{NY} (See Section 2.2.)
159	Exposure	EX	EXADJ	Reason adjusted	text		Req	Describes reason or explanation of why a dose is adjusted - used only when an adjustment is represented in EXPOSURE dataset. May be used for variations from protocol-specified doses, or changes from expected doses.
160	Exposure	EX	EXDOSFRQ	Frequency	text	CL.FREQ.SUBSET.EXDOSFRQ_2011-10-24	Req	Number of doses given per a specific interval. {FREQ} (See Section 2.2.)
161	Exposure	EX	EXROUTE	Route	text	CL.ROUTE.SUBSET.EXROUTE_2011-10-24	Req	Route of administration for EXTRT. {ROUTE} (See Section 2.2.)
162	Exposure	EX	EXINTRP	Interruption Duration	durationDatetime		Req	Duration of the treatment interruption.
163	Exposure	EX	EXLOC	Anatomical Location	text	CL.LOC.SUBSET.EXLOC_2011-10-24	Req	Specifies anatomical location of administration. {LOC} (See Section 2.2.)
164	Exposure	EX	EXVAMT	Total Amount	float		Req	Total amount of study treatment (drug + vehicle) administered or given to the subject.
165	Exposure	EX	EXFLRT	Infusion Rate	float		Req	Rate of infusion.
166	Exposure	EX	EXMEDCMP	Completed treatment	text	CL.NY_SUB_Y_N_2011-10-24	Req	Subject did not did not complete the intended regiment.{NY} (See Section 2.2.)
167	Exposure	EX	EXPDOSE	Planned Dose	float		Req	Planned dose per administration.
168	General information	PE	PEPERF	Exam performed	text	CL.NY_SUB_Y_N_2011-10-24	Req	Used to indicate if the overall physical examination was performed as scheduled.Was the physical examination performed? {NY} (See Section 2.2.)
169	General information	DVYN	DVYN	Any Deviations?	text	CL.NY_SUB_Y_N_2011-10-24	Req	Indication of whether or not there was a protocol deviation. {NY} (See Section 2.2.)
170	Details	DV	DVTERM	Protocol Deviation or Other, Specify	text		Req	DVTERM is the verbatim text.
171	Details	DV	DVSTDTC	Start Date and Time	partialDatetime		Req	Start date and time of Deviation.
172	Details	DV	DVENDTC	End Date and Time	partialDatetime		Req	End date and time of Deviation.

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

History and Lifecycle

Modified:4/3/2015 6:27 PM

Created:4/2/2015 12:01 PM

	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
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

L4C_RA0091

Adverse Event
AE1001

Weight*
WHT1001

SIM Properties

History and Lifecycle

Pull from standards or similar studies

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6 matches

L4C_RA0091

Adverse Event AE1001

Weight* WHT1001

SIM Properties

History and Lifecycle

Pull from standards or similar studies

34 matches

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Find a code system

6 matches

Adverse Event
AE1001

Weight*
WHT1001