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Forms in CM (7)

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Anti-hyperglycemic agents

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

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#	Question	Response / annotation
1	Collection Date cm801_1.CMDAT	CMDTC
2	Did the subject take any anti-hyperglycemic agent in the last 10 years? cm801_1.CMOCCUR	Yes No CMOCCUR when CMTRT = ANTI-HYPERGLYCEMIC CMPRESP = Y CMEVLINT = -P10Y
3	If yes, List the Treatments received field_003
4	Treatment Name cm801_1.CMTRT	CMTRT
5	Start Date cm801_1.CMSTDAT	CMSTDTC
6	Ongoing? cm801_1.CMONGO	Yes No CMENRTPT
7	End Date cm801_1.CMENDAT	CMENDTC
8	Dose cm801_1.CMDOSE	CMDOSE
9	Dose Unit cm801_1.CMDOSU	mg ug mL g IU CMDOSU
10	Frequency cm801_1.CMDOSFRQ	BID TID QID QOD QM PRN UNKNOWN CMDOSFRQ
11	Route cm801_1.CMROUTE	ORAL TOPICAL SUBCUTANEOUS TRANSDERMAL INTRAOCULAR INTRAMUSCULAR RESPIRATORY (INHALATION) INTRAPERITONIAL NASAL RECTAL CMROUTE

General Concomitant Medications

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

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#	Question	Response / annotation
1	Treatment Name cm801_2.CMTRT	CMTRT
2	Taken prior to the study? cm801_2.CMPRIOR	Yes No CMPRIOR in SUPPCM
3	Indication cm801_2.CMINDC	CMINDC
4	Start Date cm801_2.CMSTDAT	CMSTDTC
5	Ongoing? cm801_2.CMONGO	Yes No CMENRTPT
6	End Date cm801_2.CMENDAT	CMENDTC
7	Dose cm801_2.CMDOSE	CMDOSE
8	Dose Unit cm801_2.CMDOSU	mg ug mL g IU CMDOSU
9	Frequency cm801_2.CMDOSFRQ	BID TID QID QOD QM PRN UNKNOWN CMDOSFRQ
10	Route cm801_2.CMROUTE	ORAL TOPICAL SUBCUTANEOUS TRANSDERMAL INTRAOCULAR INTRAMUSCULAR RESPIRATORY (INHALATION) INTRAPERITONIAL NASAL RECTAL CMROUTE

Heart Failure Maintenance Medications

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

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#	Question	Response / annotation
1	Were any angiotensin-converting enzyme (ACE) inhibitors taken? ACEHF_CMOCCUR	Yes No CMOCCUR when CMTRT = ACE Inhibitors
2	If No, provide reason for not prescribing ACE inhibitors. ACEHF_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = ACE Inhibitors
3	Were any beta blockers taken? BBHF_CMOCCUR	Yes No CMOCCUR when CMTRT = Beta Blockers
4	If No, provide reason for not prescribing beta blockers. BBHF_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = Beta Blockers
5	Were any angiotensin receptor blockers (ARBs) taken? ARBHF_CMOCCUR	Yes No CMOCCUR when CMTRT = ARBs
6	If No, provide reason for not prescribing ARBs. ARBHF_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = ARBs
7	Were any angiotensin receptor/neprilysin inhibitors (ARNIs) taken? ARNI_CMOCCUR	Yes No CMOCCUR when CMTRT = ARNIs
8	If No, provide reason for not prescribing ARNIs. ARNI_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = ARNIs
9	Were any aldosterone antagonists taken? ALDO_CMOCCUR	Yes No CMOCCUR when CMTRT = Aldosterone Antagonists
10	If No, provide reason for not prescribing aldosterone antagonists. ALDO_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = Aldosterone Antagonists
11	Was any hydralazine taken? HYDISO_CMOCCUR	Yes No CMOCCUR when CMTRT = Hydralazine
12	If No, provide reason for not prescribing hydralazine. HYDISO_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = Hydralazine
13	Were any diuretics taken? DIURETICS_CMOCCUR	Yes No CMOCCUR when CMTRT = Diuretics
14	If No, provide reason for not prescribing diuretics. DIURETICS_CMREASOC	Contraindication Treatment not indicated Cost Unknown CMREASOC in SUPPCM when CMTRT = Diuretics

Prior Systemic Anti-Cancer Therapy Regimen

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

RS (Disease Response and Clin Classification)

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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

Concomitant Medications

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

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#	Question	Response / annotation
1	Medication category conmeds.CMCAT	CMCAT
2	Medication conmeds.CMVT	CMTRT
3	Taken prior to study? field_003	No Yes CMSTRTPT
4	Date First Taken conmeds.CMSTDT_RAW	CMSTDTC
5	Date Last Taken conmeds.CMENDT_RAW	CMENDTC
6	Indication conmeds.CMINDC	CMINDC
7	Dose conmeds.CMDOSE_RAW	CMDOSE
8	Unit conmeds.CMDOSEU_RAW	CMDOSU
9	Frequency conmeds.CMDOSFRQ	CMDOSFRQ
10	Route conmeds.ROUTE	CMROUTE

Heart Failure History

Sources: DB1, SDTM | Forms loaded: 7

MH (Medical History)

RS (Disease Response and Clin Classification)

CM (Concomitant Medications)

HO (Healthcare Encounters)

CV (Cardiovascular System Findings)

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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

Concomitant Medication Log

Sources: DB1, SDTM | Forms loaded: 7

CM (Concomitant Medications)

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#	Question	Response / annotation
1	Subject Identifier PT	USUBJID
2	Medication Name CMTRT_RAW	CMTRT
3	Dose CMDOSE_RAW	CMDOSE
4	Dose Units CMDOSU_RAW	CMDOSU
5	Dose Form CMDOSFRM_RAW	CMDOSFRM
6	Frequency CMDOSFRQ_RAW	CMDOSFRQ
7	Route CMROUTE_RAW	CMROUTE
8	Indication CMINDC_RAW	CMINDC
9	Start Date CMSTDT_RAW	CMSTDTC
10	End Date CMENDT_RAW	CMENDTC