Allogeneic Heart Stem Cells to Achieve Myocardial Regener... | NCT01458405

ID	Type	Description	Link
RC3HL103356-01	U.S. NIH Grant/Contract		View source

Name	Class
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH
California Institute for Regenerative Medicine (CIRM)	OTHER

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
CAP-1002 Allogeneic Cardiosphere-Derived Cells	Active Comparator		Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Name	Type	Description	Arm Group Labels	Other Names
CAP-1002 Allogeneic Cardiosphere-Derived Cells	Biological	Single dose, blinded, intracoronary infusion of 25 Million cardiosphere-derived cells	CAP-1002 Allogeneic Cardiosphere-Derived Cells

Measure	Description	Time Frame
Number of Participants Experiencing Any of the Adjudicated Events	Adjudicated Events reported included: Acute myocarditis; Death due to ventricular tachycardia (VT) or ventricular fibrillation (VF); Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); and Major adverse cardiac event (MACE) (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, left ventricular assist device [LVAD] placement or heart transplant).	Within 1-month post-infusion
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 12	Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of left ventricular (LV) areas from all sections (including those without infarct scar) and multiplying by 100. Percent improvement in infarct size defined by scar as a percent of LV mass was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.	Baseline, Month 12

Measure	Description	Time Frame
Number of Participants Experiencing Any of the Adjudicated Events	Adjudicated Events reported included: Acute myocarditis; Death due to VT or VF; Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); MACE (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, LVAD placement or heart transplant); New cardiac tumor formation on MRI imaging; Any hospitalization due to cardiovascular cause; Any inter-current cardiovascular illness or one related to CAP-1002 or placebo infusion, which prolongs hospitalization; New thrombolysis in myocardial infarction (TIMI) flow <=1; Development of, or an increase in frequency of VT; Development of increased anti-human leukocyte antigen (anti-HLA) antibody levels (mean fluorescence intensity [MFI] >= 1000; 5000) with development of sensitization to HLA antigens specific to CAP-1002 cardiosphere-derived cells donor.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or Creatine phosphokinase MB isoenzyme (CK-MB) >5 times the upper limit of normal. Also at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
History of percutaneous coronary intervention (PCI), with stent placement resulting in Thrombolysis in Myocardial Infarction (TIMI) flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
At least one assessment of left ventricular ejection function (LVEF) <=0.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period.
- For participants that fulfill the criteria of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and the most recent test prior to or during the screening period.
- For participants that fulfill the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to or during the screening period.
Note: participants may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.
Left ventricular infarct size of >= 15% of left ventricular mass in the qualifying infarct-related region to be infused as determined by centrally read screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the infarcted regions.
No further revascularization clinically indicated at the time the participants is assessed for participation in the clinical trial.
Ability to provide informed consent and follow-up with protocol procedures.
Age >= 18 years.

Exclusion Criteria

Participants with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.
Diagnosed or suspected myocarditis.
History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
History of acute coronary syndrome in the 4 weeks prior to study infusion.
History of previous stem cell therapy.
History of radiation treatment to the central or left side of thorax.
Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic recurrent or persistent pericarditis.
History of or current treatment with immunosuppressive, anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-vascular endothelial growth factor, or chemotherapeutic agents within 3 months prior to enrollment.
Prior implantable cardioverter defibrillator (ICD) and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in participants with ICD and/or pacemaker placement.

a. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions are excluded: i. Manufactured before the year 2000, ii. Leads implanted < 6 weeks prior to signing informed consent, iii. Non-transvenous epicardial, abandoned, or no-fixation leads, iv. Subcutaneous ICDs, v. Leadless pacemakers, vi. Any other condition that, in the judgement of device-trained staff, would deem an MRI contraindicated.

b. Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded).

c. A cardiac resynchronization therapy (CRT) device implanted < 3 months prior to signing informed consent.
Estimated glomerular filtration rate < 30 mL/min.
Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days.
Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
Current alcohol or drug abuse.
Pregnant/nursing women and women of child-bearing potential that do not agree to use at least two forms of active and highly reliable method(s) of contraception. Acceptable methods of contraception include contraceptive pills, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide or gel, or an intrauterine device (IUD).
Human Immunodeficiency Virus (HIV) infection.
Viral hepatitis.
Uncontrolled diabetes (HbA1c>9%).
Abnormal liver function (Serum Glutamic Pyruvic Transaminase/Alanine aminotransferase > 3 times the upper reference range) and/or abnormal hematology (hematocrit < 25%, White Blood Cell < 3000 µl, platelets < 100,000 µl) studies without a reversible, identifiable cause.
Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats, not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new acute ischemic episode.
Ventricular fibrillation not associated with a new acute ischemic episode.
New York Heart Association (NYHA) Class IV congestive heart failure.
Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
Any prior transplant.
Known hypersensitivity to dimethyl sulfoxide (DMSO).
Known hypersensitivity to bovine products.
Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the informed consent form.
Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the participants unsuitable for the study.

Name	Affiliation	Role
Frank Litvack, MD	Capricor Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology, P.C.		Birmingham	Alabama	35211	United States
Heart Center Research

PubMed Identifier	Type	Citation	Retractions
34233913	Derived	Ostovaneh MR, Makkar RR, Ambale-Venkatesh B, Ascheim D, Chakravarty T, Henry TD, Kowalchuk G, Aguirre FV, Kereiakes DJ, Povsic TJ, Schatz R, Traverse JH, Pogoda J, Smith RD, Marban L, Marban E, Lima JAC. Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial. Open Heart. 2021 Jul;8(2):e001614. doi: 10.1136/openhrt-2021-001614.
32749459	Derived	Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marban L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marban E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2020 Sep 21;41(36):3451-3458. doi: 10.1093/eurheartj/ehaa541.

ID	Title	Description
FG000	Phase 1: Safety Cohort:12.5 M CDCs	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002(12.5 million [M] cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 22, 2017	Feb 9, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Experiencing Any of the Adjudicated Events

Adjudicated Events reported included: Acute myocarditis; Death due to ventricular tachycardia (VT) or ventricular fibrillation (VF); Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); and Major adverse cardiac event (MACE) (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, left ventricular assist device [LVAD] placement or heart transplant).

Analysis was performed on safety population that included all participants who received investigational product. Data this outcome measure was not planned to be collected and reported for Phase 1 part of the study.

Posted

Count of Participants

Participants

Within 1-month post-infusion

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Units	Counts
Participants	OG00044 OG00177

Title

Denominators

Categories

Acute myocarditis

Title	Measurements
	OG0000 OG0010

Death due to VT/VF

Title	Measurements
	OG000

Primary

Percent Change From Baseline in Myocardium Mass Infarct Size at Month 12

Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of left ventricular (LV) areas from all sections (including those without infarct scar) and multiplying by 100. Percent improvement in infarct size defined by scar as a percent of LV mass was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Analysis was performed on Modified Intent-to-Treat (mITT) population that included all participants in the primary randomization cohort who received investigational product, had a baseline observation, and at least one post-baseline observation. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and reported for Phase 1 part of the study.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Secondary

Number of Participants Experiencing Any of the Adjudicated Events

Adjudicated Events reported included: Acute myocarditis; Death due to VT or VF; Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); MACE (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, LVAD placement or heart transplant); New cardiac tumor formation on MRI imaging; Any hospitalization due to cardiovascular cause; Any inter-current cardiovascular illness or one related to CAP-1002 or placebo infusion, which prolongs hospitalization; New thrombolysis in myocardial infarction (TIMI) flow <=1; Development of, or an increase in frequency of VT; Development of increased anti-human leukocyte antigen (anti-HLA) antibody levels (mean fluorescence intensity [MFI] >= 1000; 5000) with development of sensitization to HLA antigens specific to CAP-1002 cardiosphere-derived cells donor.

Analysis was performed on safety population that included all participants in the primary randomization cohort who received investigational product. Data for this outcome measure was not planned to be collected and reported for Phase 1 part of the study.

Posted

Count of Participants

Participants

Up to Month 12 post-infusion

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12

LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). LVEF expressed as percentage ejection fraction was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.

Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and reported for Phase 1 part of the study.

Posted

Mean

Standard Deviation

percent change ejection fraction

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12

LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Percent change in LVEF was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12

LVEDV is the amount of blood in the heart's left ventricle just before the heart contracts. LVEDV was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.

Posted

Mean

Standard Deviation

milliliters (mL)

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12

LVEDV is the amount of blood in the heart's left ventricle just before the heart contracts. Percent change in LVEDV was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12

LVESV is the amount of blood remaining in the ventricle at the end of systole, after the heart has contracted. LVESV was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.

Posted

Mean

Standard Deviation

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12

LVESV is the amount of blood remaining in the ventricle at the end of systole, after the heart has contracted. Percent change in LVESV was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12

Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of LV areas from all sections (including those without infarct scar) and multiplying by 100. Improvement in infarct size as a percent of LV mass was assessed by magnetic resonance imaging.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12

Infarct size in grams was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.

Posted

Mean

Standard Deviation

grams

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12

Percent change in infarct size was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Viable Mass at Month 6 and 12

Viable mass expressed in grams was assessed by magnetic resonance imaging. Myocardial viable mass refers to myocardial cells that are alive after myocardial injury, according to cellular, metabolic and contractile functions. Absolute change was calculated as: post-baseline value-Baseline value.

Posted

Mean

Standard Deviation

grams

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Viable Mass at Month 6 and12

Percent change in viable mass was assessed by magnetic resonance imaging. Myocardial viable mass refers to myocardial cells that are alive after myocardial injury, according to cellular, metabolic and contractile functions. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12

The regions assessed of the heart were: Anterior, Lateral, Inferior and Septal. Tissue mass recovery in the function of region receiving therapy expressed as percentage improvement was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12

The regions assessed of the heart were: Anterior, Lateral, Inferior and Septal. Tissue mass recovery in the function of region receiving therapy expressed as percentage improvement was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%.

Posted

Mean

Standard Deviation

percent change

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Change From Baseline in Six-Minute Walk Test at Month 6 and 12

The six-minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes.

Posted

Mean

Standard Deviation

meters

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12

Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. Responses are recorded on six-point Likert scales, ranging from 0 (none) to 5 (very much). Total Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life.

Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and reported for Phase 1 part of the study.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Secondary

Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12

The Short Form (36) Health Survey is a 36-item, patient-reported survey of participant health. The SF-36 consists of eight scaled scores (Physical Function, Physical Health, Emotional Problems, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain Scale and General Health) which are the weighted sums of the questions in their section. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better participant status.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12

WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities during the last 7 days. Four scores are derived as percent: Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment. Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity.

Posted

Mean

Standard Deviation

percentage impairment

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Secondary

Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12

PGA will ask participants to assess how their overall status has changed since prior to receiving the therapy. Possible PGA responses are "0=none", "1=mild", "2=moderate", "and 3=severe". Change from Baseline was calculated as lowest PGA score on scheduled visits minus PGA score at Baseline which resulted in possible ranges from -3 to +3. Decreasing scores indicate improvement.

Posted

Count of Participants

Participants

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12

New York Heart Association (NYHA) Classification: Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Change from Baseline was calculated as lowest NYHA score on scheduled visits minus NYHA score at Baseline which resulted in possible ranges from -3 to +3. Decreasing scores indicate improvement.

Posted

Count of Participants

Participants

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Secondary

Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12

NT-proBNP was the cardiac biomarkers assessed through serum sample.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Secondary

Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12

NT-proBNP was the cardiac biomarkers assessed through serum sample.

Posted

Mean

Standard Deviation

log pg/mL

Baseline, Month 6 and Month 12

ID	Title	Description
OG000	Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
OG001	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected10 at risk EG0022 events1 affected44 at risk EG0031 events1 affected77 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0023 events2 affected44 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0024 events3 affected44 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected10 at risk EG0022 events2 affected44 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0022 events2 affected44 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Chest Discomfort	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected4 at risk EG0011 events1 affected10 at risk EG0021 events1 affected44 at risk EG003
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events1 affected10 at risk EG0021 events1 affected44 at risk EG003
Catheter Site Related Reaction	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Chest Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0026 events6 affected44 at risk EG003
Drug Intolerance	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Mucosal Inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected4 at risk EG0012 events2 affected10 at risk EG0025 events2 affected44 at risk EG003
Ear Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Furuncle	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Implant Site Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected10 at risk EG0022 events2 affected44 at risk EG003
Brain Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Corneal Abrasion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Foreign Body	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Troponin I Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0021 events1 affected44 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0021 events1 affected44 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0026 events4 affected44 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0026 events6 affected44 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected10 at risk EG0025 events3 affected44 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Dizziness Postural	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0021 events1 affected44 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0024 events2 affected44 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0013 events2 affected10 at risk EG0021 events1 affected44 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected10 at risk EG0021 events1 affected44 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0025 events4 affected44 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events1 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected10 at risk EG0020 events0 affected44 at risk EG003
Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events2 affected10 at risk EG0025 events5 affected44 at risk EG003
Anaemia Macrocytic	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Angina Unstable	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Anginal Equivalent	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Atrial Thrombosis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Atrioventricular Block	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Bradycardia And Hypotension	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Bundle Branch Block Left	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Cardiac Aneurysm	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Cardiac Failure Acute	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Cardiac Failure Chronic	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0023 events3 affected44 at risk EG003
Cardiac Ventricular Thrombosis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Coronary Artery Dissection	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Coronary Artery Thrombosis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Intracardiac Thrombus	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Palpitations	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0023 events3 affected44 at risk EG003
Sinus Bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Ventricular Extrasystoles	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Ventricular Tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Mixed Deafness	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Vertigo Positional	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Glaucoma	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Hyphaema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events1 affected44 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Food Poisoning	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Catheter Site Bruise	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Hernia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Malaise	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Oedema Peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Peripheral Swelling	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Swelling	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Hepatic Lesion	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Folliculitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Hordeolum	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Influenza	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Oral Herpes	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Otitis Media	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Rash Pustular	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Tinea Pedis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Tooth Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0024 events3 affected44 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events1 affected44 at risk EG003
Viral Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Vascular Injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Implantable Defibrillator Insertion	Surgical and medical procedures	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Arteriovenous Fistula	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Haematoma	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0023 events3 affected44 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0023 events2 affected44 at risk EG003
Hypertensive Crisis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Intermittent Claudication	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Orthostatic Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
ALT Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
AST Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Blood Glucose Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Blood Potassium Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Blood Uric Acid Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Cardiac Murmur	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
ECG PR Prolongation	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
ECG ST Segment Depression	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
ECG ST Segment Elevation	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Ejection Fraction Decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Haematocrit Decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Haemoglobin Decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Mean Cell Haemoglobin Conc Dec	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Mean Cell Haemoglobin Decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Red Blood Cells Urine	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Red Cell Distribution Width Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Transaminases Increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Fluid Retention	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Dupuytrens Contracture	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0025 events5 affected44 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Adrenal Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Plasma Cell Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Diabetic Neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Ischaemic Stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Presyncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0022 events2 affected44 at risk EG003
Sciatica	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Sensory Disturbance	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Alcohol Withdrawal Syndrome	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Libido Decreased	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Panic Attack	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Suicidal Ideation	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Diabetic Nephropathy	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
COPD	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0025 events5 affected44 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0020 events0 affected44 at risk EG003
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected10 at risk EG0021 events1 affected44 at risk EG003

ID	Title	Description
BG000	Phase 1: Safety Cohort:12.5 M CDCs	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (12.5 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
BG001	Phase 1: Safety Cohort: 25 M CDCs	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
BG002	Phase 2: Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
BG003	Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.
BG004	Total	Total of all reporting groups

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D018754	Ventricular Dysfunction

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1: Safety Cohort:12.5 M CDCs	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (12.5 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	4	0	4	4	4
EG001	Phase 1: Safety Cohort: 25 M CDCs	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	10	0	10	10	10
EG002	Phase 2: Randomized Treatment Cohort: Placebo	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	44	15	44	24	44
EG003	Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells	Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	77	20	77	42	77

ID	Term
D009203	Myocardial Infarction
D018487	Ventricular Dysfunction, Left
D006333	Heart Failure