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Forms in HO (4)

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Adverse Events

Sources: DB1 | Forms loaded: 4

AE (Adverse Events)

FA (Findings About Events or Interventions)

HO (Healthcare Encounters)

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AE, FA, HO

#	Question	Response / annotation
1	Adverse Event Verbatim field_001	AETERM FAOBJ
2	Event Category field_002	General Adverse Event Event of Interest AECAT
3	Did the event start before administering first dose of study medication? field_003	Yes No PRFDOS in SUPPAE
4	Date Started field_004	AESTDTC
5	Event ongoing? field_005	No Yes AEENRTPT
6	Date Ended field_006	AEENDTC
7	Severity of the Event field_007	Mild Moderate Severe AESEV
8	Event Related to Study Drug field_008	Yes No AEREL
9	Toxicity Grade of the Event (CTCAE) field_009	1 2 3 4 5 AETOXGR
10	Action Taken with Study Drug because of Adverse Event field_010	No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn AEACN
11	Other action taken? field_011	AEACNOTH
12	Serious Event? field_012	Yes No AESER
13	Resulted in Death? field_013	Yes No AESDTH
14	Immediately Life Threatening? field_014	Yes No AESLIFE
15	Required Hospitalization or Prolonged Hospitalization? field_015	Yes No AESHOSP
16	Hospital admission details field_016
17	Date of hospitalization field_017	HOSTDTC
18	Time of hospitalization field_018	HOSTDTC
19	Hospital discharge details field_019
20	Date of discharge field_020	HOENDTC
21	Time of discharge field_021	HOENDTC
22	Persistent or Significant Disability? field_022	Yes No AESDISAB
23	Congenital Anomaly/Birth Defect? field_023	Yes No AESCONG
24	Other Medically Important Serious Event? field_024	Yes No AESMIE
25	Outcome of the Event? field_025	Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown AEOUT
26	Was the event adjudicated? field_026	Yes No FAORRES when FATESTCD = ADJUD
27	Adjudication Result field_027	Positive Negative FAORRES when FATESTCD = ADJRES
28	Relationship to Non-Study Treatment field_028	Adjunct Therapy Study Disease Other Medical Condition Study Procedure None AERELNST

Healthcare Encounters

Sources: DB1 | Forms loaded: 4

HO (Healthcare Encounters)

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#	Question	Response / annotation
1	Has the subject reported any healthcare encounters? HOYN	Yes No [NOT SUBMITTED]
2	Healthcare Encounter Category HOCAT	Outpatient Encounter HOCAT
2	Healthcare Encounter Category HOCAT1	Inpatient Encounter HOCAT
3	Healthcare Encounter HOCTERM	Physical Therapy Clinic HOTERM
4	Did the subject have physical rehabilitation services? HOCCUR	Yes No HOOCCUR
5	What was the reason for the physical rehabilitation services? HOREAS	HOREAS in SUPPHO
6	What was the adverse event identifier that precipitated this encounter? HOAENO	HOLNKID RELREC when HOLNKID = AELNKID
7	Healthcare Encounter HOCTERM2	HOTERM
8	Was the subject admitted to the ICU? ICUOCCUR	Yes No HOOCCUR
9	Admission Date ICUSDAT	HOSTDTC
10	Was the ICU admission still ongoing? ICUONGO	Yes No HOENRTPT
11	How long was the subject in ICU? ICUDUR	HODUR
12	Duration Unit ICUDURU	Days Weeks HODUR

Hospitalizations

Sources: DB1 | Forms loaded: 4

HO (Healthcare Encounters)

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#	Question	Response / annotation
1	Date Admitted field_001	HOSTDTC
2	Date Discharged field_002	HOENDTC
3	Reason for Hospitalization field_003	Adverse Event Normal Clinical Practice Other HOREAS in SUPPHO
4	Hospital Unit field_004	ICU General Ward Emergency Room Other HOTERM
5	Linking ID to an Event field_005	HOLNKID

Heart Failure History

Sources: DB1 | Forms loaded: 4

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