crfgen - JSON CRF Library

Forms in RS (9)

Click a form to render

Prior Systemic Anti-Cancer Therapy Regimen

Sources: DB1, SDTM | Forms loaded: 9

CM (Concomitant Medications)

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

CM, RS

#	Question	Response / annotation
1	Category for Medication CMCAT	CMCAT = PRIOR SYSTEMIC ANTI-CANCER THERAPY RSCAT = PRIOR SYSTEMIC ANTI-CANCER THERAPY
2	Type of Therapy CMSCAT	Chemotherapy Hormonal Therapy Biologic Therapy Targeted Therapy Other CMSCAT
3	Therapy Setting TRTSTT	Adjuvant Conditioning Consolidation Induction Locally Advanced Maintenance Metastatic Mobilization Neo-Adjuvant Preventative Radiosensitization Salvage TRTSTT in SUPPCM
4	Regimen Number CMGRPID	Regimen 1 Regimen 2 Regimen 3 Regimen 4 CMGRPID RELREC when CMGRPID = RSLNKID
5	Best Overall Response RSORRES_BESTRESP	Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) Not Evaluable (NE) Unknown RSORRES when RSTESTCD = BESTRESP
6	Date of Best Overall Response RSDAT	RSDTC when RSTESTCD = BESTRESP
7	Date of Progressive Disease RSDAT_PD	RSDTC when RSTESTCD = OVRLRESP RSORRES = PD when RSTESTCD = OVRLRESP
8	Line Number CMSPID	CMSPID
9	Agent (one agent or therapy per line) CMTRT	CMTRT
10	Start Date CMSTDAT	CMSTDTC
11	End Date CMENDAT	CMENDTC
12	Dose CMDOSE	CMDOSE
13	Dose (text) CMDOSTXT	CMDOSTXT
14	Dose Unit CMDOSU	CMDOSU
15	If Other, specify CMDOSU_OTH	CMDOSU
16	Frequency CMDOSFRQ	CMDOSFRQ
17	If Other, specify CMDOSFRQ_OTH	CMDOSFRQ
18	Number of Cycles CMNCYC	CMNCYC in SUPPCM

Heart Failure History

Sources: DB1, SDTM | Forms loaded: 9

MH (Medical History)

RS (Disease Response and Clin Classification)

CM (Concomitant Medications)

HO (Healthcare Encounters)

CV (Cardiovascular System Findings)

Show domain info

Primary Domain

All Domains

MH, RS, CM, HO, CV

#	Question	Response / annotation
1	What type of heart failure does the subject have? MHTERM	Heart failure with preserved ejection fraction (HFpEF) Heart failure with midrange ejection fraction (HFmrEF) Heart failure with reduced ejection fraction (HFrEF) MHTERM
2	What was the date of diagnosis of heart failure? MHSTDAT	MHSTDTC
3	What was the primary cause of heart failure? MHPRC	High blood pressure Coronary artery disease Faulty heart valves Cardiomyopathy Abnormal heart rhythms Other, specify MHPRC in SUPPMH
4	Specify Other MHPRCOTH	MHPRCOTH in SUPPMH
5	What is the etiology of the heart failure? MHETOLGY	Ischemic Non-ischemic MHETOLGY in SUPPMH
6	What was the NYHA functional classification at entry into the study? NHYACLS_RSORRES	I II III IV RSORRES when RSTEST = NYHA Functional Classification
7	Was the subject ever administered IV diuretics for heart failure? IVD_CM_OCCUR	Yes No CMOCCUR CMTRT = DIURETICS CMPRESP = Y CMROUTE = INTRAVENOUS
8	Did the subject have any episodes of worsening heart failure in the last 6 months? HFWOR_MHOCCUR	Yes No MHOCCUR when MHTERM = WORSENING HEART FAILURE MHPRESP = Y
9	What was the start date of the most recent episode of worsening heart failure in the last 6 months? HFWOR_MHSTDAT	MHSTDTC when MHTERM = WORSENING HEART FAILURE
10	Did this event require hospitalization? HOCCUR	Yes No HOOCCUR HOTERM = HOSPITALIZATION HOPRESP = Y
11	What was the date of the test to determine estimated LVEF? CVDAT	CVDTC when CVTESTCD = LVEF
12	What was the estimated LVEF at entry into the study? CVORRES	CVORRES when CVTESTCD = LVEF
13	What was the method used to determine the estimated LVEF? CVMETHOD	MUGA Echocardiography Cardiac catheterization Cardiac CT scan Cardiac MRI CVMETHOD when CVTESTCD = LVEF

New Lesion

Sources: DB1, SDTM | Forms loaded: 9

TU (Tumor Identification)

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

TU, RS

#	Question	Response / annotation
1	Lesion Number field_001	NL01 NL02 NL03 NL04 NL05 NL06 NL07 NL08 NL09 NL10 NL11 NL12 NL13 NL14 NL15 NL16 NL17 NL18 NL19 NL20 TULNKID RSLNKID
2	Date of Assessment field_002	TUDTC RSDTC
3	Anatomical Location field_003	Adrenal Gland Arm Axilla Brain Bladder Bone Breast Buttock Ear Other TULOC
4	Anatomical Location Other Specify field_004	TULOCOTH in SUPPTU
5	Laterality field_005	Left Right TULAT
6	Directionality field_006	Anterior Posterior Deep Distal Inferior TUDIR
7	Method of Evaluation field_007	X-Ray CT Scan MRI PET TUMETHOD
8	Status field_008	Complete Response (CR) Non-CR/Non-PD Progressive Disease (PD) Not Evaluable (NE) RSORRES

Non-target Lesion

Sources: DB1, SDTM | Forms loaded: 9

TU (Tumor Identification)

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

TU, RS

#	Question	Response / annotation
1	Lesion Number field_001	NTL01 NTL02 NTL03 NTL04 NTL05 NTL06 NTL07 NTL08 NTL09 NTL10 NTL11 NTL12 NTL13 NTL14 NTL15 NTL16 NTL17 NTL18 NTL19 NTL20 TULNKID RSLNKID
2	Date of Assessment field_002	TUDTC RSDTC
3	Anatomical Location field_003	Adrenal Gland Arm Axilla Brain Bladder Bone Breast Buttock Ear Other TULOC
4	Anatomical Location Other Specify field_004	TULOCOTH in SUPPTU
5	Laterality field_005	Left Right TULAT
6	Directionality field_006	Anterior Posterior Deep Distal Inferior TUDIR
7	Method of Evaluation field_007	X-Ray CT Scan MRI PET TUMETHOD
8	Status field_008	Complete Response (CR) Non-CR/Non-PD Progressive Disease (PD) Not Evaluable (NE) RSORRES

ECOG Performance Status

Sources: DB1, SDTM | Forms loaded: 9

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

#	Question	Response / annotation
1	Date of assessment field_001	RSDTC
2	Subject ECOG status field_002	Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Grade 5: Dead RSORRES when RSTESTCD = ECOG101
3	ECOG performance status field_003	RSCAT = ECOG

ECOG Performance Status

Sources: DB1, SDTM | Forms loaded: 9

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

#	Question	Response / annotation
1	Was ECOG performed? RSSTAT	Yes [NOT SUBMITTED] No RSSTAT = NOT DONE when RSTESTCD = ECOG101
2	Collection Date RSDAT	RSDTC
3	Collection Time RSTIM	RSDTC
4	Evaluator RSEVAL	Investigator Sub-Investigator Study Coordinator Other RSEVAL
5	Evaluator Other, Specify RSEVALOTH	RSEVAL
6	Performance Status RSORRES_ECOG	0 - Fully active, able to carry on all pre-disease performance without restriction 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 - Dead RSORRES when RSTESTCD = ECOG101

Disease Response (RECIST 1.1)

Sources: DB1, SDTM | Forms loaded: 9

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

#	Question	Response / annotation
4	Response Date RSDAT	RSDTC
5	Target Response TRGRESP_RSORRES	CR PR SD PD RSORRES when RSTESTCD = TRGRESP
7	Non-target Response NTRGRESP_RSORRES	CR Non-CR/Non-PD/PD RSORRES when RSTESTCD = NTRGRESP
10	Overall Response OVRLRESP_RSORRES	CR PR SD PD NE RSORRES when RSTESTCD = OVRLRESP
11	Response Evaluator RSEVAL	RSEVAL

Disease Response YN?

Sources: DB1, SDTM | Forms loaded: 9

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

#	Question	Response / annotation

Investigator Tumor Response Assessment

Sources: DB1, SDTM | Forms loaded: 9

RS (Disease Response and Clin Classification)

CE (Clinical Events)

Show domain info

Primary Domain

All Domains

RS, CE

#	Question	Response / annotation
1	Was the Investigator's assessment of overall response obtained? field_001	Yes No [NOT SUBMITTED]
2	Investigator's assessment of overall response field_002	Complete Remission (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) RSORRES when RSTESTCD = OVRLRESP
3	Response Assessment Date field_003	RSDTC when RSTESTCD = OVRLRESP
4	Reason the Investigator's assessment of overall response was not obtained field_004	Not Evaluable (NE) RSORRES = NE when RSTESTCD = OVRLRESP No Assessment Performed RSSTAT = NOT DONE when RSTESTCD = OVRLRESP RSORRES / RSSTAT when RSTESTCD = OVRLRESP
5	Did the patient experience symptomatic deterioration? field_005	Yes No CEOCCUR when CETERM = SYMPTOMATIC DETERIORATION CEPRESP = Y
6	Date of Symptomatic Deterioration field_006	CESTDTC when CETERM = SYMPTOMATIC DETERIORATION