Trial Outcomes & Findings for Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (NCT NCT01458405)

NCT ID: NCT01458405

Last Updated: 2024-04-09

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 135 participants
• Primary outcome timeframe: Within 1-month post-infusion
• Results posted on: 2024-04-09

Participant Flow

The study enrolled participants at 30 active sites between 13 November 2012 to 03 July 2017. Study had 2 phases: Phase 1 (safety cohort) and Phase 2 (randomized double-blind cohort).

After completion of screening procedures, and at least 4 weeks after myocardial infarction (MI), eligible Phase 1 participants received CAP-1002. In Phase 2, participants were randomized in 2:1 ratio to receive treatment with either CAP-1002 or placebo. Based on available clinical data at time of analysis, Sponsor decided not to pursue development of CAP-1002 in this indication; hence trial was stopped. Outcome measures data was planned to be collected and reported for Phase 2 part of study.

Participant milestones

Measure	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.	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.	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 milliliters (mL) of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	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.
Phase 1 (up to 12 Months) STARTED	4	10	0	0
Phase 1 (up to 12 Months) COMPLETED	4	9	0	0
Phase 1 (up to 12 Months) NOT COMPLETED	0	1	0	0
Phase 2 (up to 12 Months) STARTED	0	0	44	77
Phase 2 (up to 12 Months) COMPLETED	0	0	33	54
Phase 2 (up to 12 Months) NOT COMPLETED	0	0	11	23

Reasons for withdrawal

Measure	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.	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.	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 milliliters (mL) of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion.	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.
Phase 1 (up to 12 Months) Other	0	1	0	0
Phase 2 (up to 12 Months) Study discontinued by Sponsor	0	0	11	20
Phase 2 (up to 12 Months) Lost to Follow-up	0	0	0	2
Phase 2 (up to 12 Months) Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration

Baseline characteristics by cohort

Measure	Phase 1: Safety Cohort:12.5 M CDCs n=4 Participants 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.	Phase 1: Safety Cohort: 25 M CDCs n=10 Participants 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.	Phase 2: Randomized Treatment Cohort: Placebo n=44 Participants 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.	Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	10 Participants n=7 Participants	44 Participants n=5 Participants	77 Participants n=4 Participants	135 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	38 Participants n=5 Participants	67 Participants n=4 Participants	118 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	8 Participants n=7 Participants	36 Participants n=5 Participants	67 Participants n=4 Participants	115 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Within 1-month post-infusion

Population: 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.

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).

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Number of Participants Experiencing Any of the Adjudicated Events Acute myocarditis	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events Death due to VT/VF	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events Sudden unexpected death	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events MACE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=28 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=46 Participants 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.
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 12	-7.11 percent change Standard Deviation 12.218	-8.80 percent change Standard Deviation 10.645

SECONDARY outcome

Timeframe: Up to Month 12 post-infusion

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Number of Participants Experiencing Any of the Adjudicated Events Acute myocarditis	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events Death due to VT/VF	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events Sudden unexpected death	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events MACE	5 Participants	5 Participants
Number of Participants Experiencing Any of the Adjudicated Events Cardiac tumor	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events CV hospitalization	7 Participants	10 Participants
Number of Participants Experiencing Any of the Adjudicated Events Prolonged CV hospitalization	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events TIMI <= 1	0 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events VT	1 Participants	0 Participants
Number of Participants Experiencing Any of the Adjudicated Events Donor-specific antibody, MFI >= 1000	3 Participants	5 Participants
Number of Participants Experiencing Any of the Adjudicated Events Donor-specific antibody, MFI >= 5000	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Month 6	0.17 percent change ejection fraction Standard Deviation 3.484	-0.02 percent change ejection fraction Standard Deviation 4.435
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Month 12	0.01 percent change ejection fraction Standard Deviation 4.089	-0.62 percent change ejection fraction Standard Deviation 5.239

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Month 6	0.82 percent change Standard Deviation 10.890	0.61 percent change Standard Deviation 11.894
Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Month 12	0.01 percent change Standard Deviation 10.228	-1.04 percent change Standard Deviation 13.956

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Month 6	11.75 milliliters (mL) Standard Deviation 23.129	3.92 milliliters (mL) Standard Deviation 23.692
Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Month 12	7.59 milliliters (mL) Standard Deviation 27.551	4.04 milliliters (mL) Standard Deviation 30.511

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Month 6	5.64 percent change Standard Deviation 10.742	2.02 percent change Standard Deviation 11.203
Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Month 12	4.68 percent change Standard Deviation 12.910	2.54 percent change Standard Deviation 13.831

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Month 6	6.96 mL Standard Deviation 17.390	2.63 mL Standard Deviation 19.000
Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Month 12	4.51 mL Standard Deviation 21.213	3.89 mL Standard Deviation 25.476

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Month 6	5.41 percent change Standard Deviation 11.928	2.34 percent change Standard Deviation 14.257
Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Month 12	4.77 percent change Standard Deviation 15.764	4.13 percent change Standard Deviation 18.572

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12 Month 6	-0.81 percent change Standard Deviation 2.109	-1.05 percent change Standard Deviation 1.699
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12 Month 12	-1.31 percent change Standard Deviation 2.684	-1.83 percent change Standard Deviation 2.432

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Month 6	-1.72 grams Standard Deviation 2.831	-1.66 grams Standard Deviation 2.927
Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Month 12	-2.57 grams Standard Deviation 4.858	-2.87 grams Standard Deviation 4.256

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Month 6	-5.14 percent change Standard Deviation 8.481	-4.67 percent change Standard Deviation 7.826
Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Month 12	-8.50 percent change Standard Deviation 13.191	-8.86 percent change Standard Deviation 11.249

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Viable Mass at Month 6 and 12 Month 6	2.40 grams Standard Deviation 9.780	0.95 grams Standard Deviation 8.143
Absolute Change From Baseline in Viable Mass at Month 6 and 12 Month 12	1.48 grams Standard Deviation 11.800	0.96 grams Standard Deviation 9.063

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Viable Mass at Month 6 and12 Month 6	2.54 percent change Standard Deviation 10.804	1.07 percent change Standard Deviation 7.698
Percent Change From Baseline in Viable Mass at Month 6 and12 Month 12	2.79 percent change Standard Deviation 10.635	1.31 percent change Standard Deviation 7.795

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Anterior: Month 6	1.21 percent change Standard Deviation 8.562	-0.61 percent change Standard Deviation 7.260
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Anterior: Month 12	0.53 percent change Standard Deviation 6.966	-1.90 percent change Standard Deviation 8.681
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Lateral: Month 6	-0.21 percent change Standard Deviation 4.731	-0.03 percent change Standard Deviation 3.857
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Lateral: Month 12	-0.98 percent change Standard Deviation 4.510	-1.15 percent change Standard Deviation 3.727
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Inferior: Month 6	0.39 percent change Standard Deviation 5.707	-0.68 percent change Standard Deviation 4.736
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Inferior: Month 12	-0.78 percent change Standard Deviation 6.255	-0.53 percent change Standard Deviation 5.614
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Septal: Month 6	-1.51 percent change Standard Deviation 5.275	-1.52 percent change Standard Deviation 4.851
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Septal: Month 12	-2.48 percent change Standard Deviation 4.948	-1.97 percent change Standard Deviation 6.445

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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%.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=42 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=74 Participants 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.
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Anterior: Month 6	6.50 percent change Standard Deviation 33.009	2.99 percent change Standard Deviation 42.147
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Anterior: Month 12	2.33 percent change Standard Deviation 18.196	-0.39 percent change Standard Deviation 42.897
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Lateral: Month 6	15.18 percent change Standard Deviation 79.223	15.09 percent change Standard Deviation 61.698
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Lateral: Month 12	178.68 percent change Standard Deviation 940.725	15.29 percent change Standard Deviation 91.948
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Inferior: Month 12	23.83 percent change Standard Deviation 131.511	78.79 percent change Standard Deviation 382.480
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Septal: Month 6	-3.17 percent change Standard Deviation 15.117	1.41 percent change Standard Deviation 42.721
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Septal: Month 12	-7.77 percent change Standard Deviation 14.477	6.22 percent change Standard Deviation 75.838
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Inferior: Month 6	14.74 percent change Standard Deviation 64.941	14.61 percent change Standard Deviation 86.589

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=43 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Change From Baseline in Six-Minute Walk Test at Month 6 and 12 Month 6	40.7 meters Standard Deviation 92.49	15.5 meters Standard Deviation 108.43
Change From Baseline in Six-Minute Walk Test at Month 6 and 12 Month 12	10.5 meters Standard Deviation 91.45	25.4 meters Standard Deviation 90.08

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12 Month 6	-5.27 score on a scale Standard Deviation 18.195	-8.30 score on a scale Standard Deviation 15.951
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12 Month 12	-8.47 score on a scale Standard Deviation 16.580	-8.89 score on a scale Standard Deviation 20.636

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Physical Health Scale: Month 6	15.72 score on a scale Standard Deviation 34.393	26.08 score on a scale Standard Deviation 46.680
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Physical Function Scale: Month 6	7.84 score on a scale Standard Deviation 19.392	6.79 score on a scale Standard Deviation 17.041
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Physical Health Scale: Month 12	21.09 score on a scale Standard Deviation 38.683	37.42 score on a scale Standard Deviation 41.171
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Emotional Problems Scale: Month 6	3.03 score on a scale Standard Deviation 31.185	8.23 score on a scale Standard Deviation 41.237
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Emotional Problems Scale: Month 12	11.46 score on a scale Standard Deviation 41.139	12.58 score on a scale Standard Deviation 32.176
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Energy/Fatigue Scale: Month 6	4.55 score on a scale Standard Deviation 20.877	7.29 score on a scale Standard Deviation 18.984
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Energy/Fatigue Scale: Month 12	8.59 score on a scale Standard Deviation 23.044	8.87 score on a scale Standard Deviation 20.254
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Emotional Well-Being Scale: Month 6	2.55 score on a scale Standard Deviation 14.794	2.18 score on a scale Standard Deviation 14.833
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Emotional Well-Being Scale: Month 12	0.50 score on a scale Standard Deviation 17.996	0.72 score on a scale Standard Deviation 13.074
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Social Functioning Scale: Month 6	8.24 score on a scale Standard Deviation 20.163	5.68 score on a scale Standard Deviation 24.379
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Social Functioning Scale: Month 12	8.59 score on a scale Standard Deviation 18.632	9.91 score on a scale Standard Deviation 27.228
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Pain Scale: Month 6	0.68 score on a scale Standard Deviation 22.022	-1.01 score on a scale Standard Deviation 21.773
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Pain Scale: Month 12	2.50 score on a scale Standard Deviation 21.166	1.04 score on a scale Standard Deviation 21.447
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 General Health Scale: Month 6	1.36 score on a scale Standard Deviation 15.971	0.19 score on a scale Standard Deviation 17.100
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 General Health Scale: Month 12	-0.94 score on a scale Standard Deviation 16.335	2.74 score on a scale Standard Deviation 14.954
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Physical Function Scale: Month 12	3.91 score on a scale Standard Deviation 13.182	6.16 score on a scale Standard Deviation 19.943

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=43 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Absenteeism: Month 6	-9.19 percentage impairment Standard Deviation 22.910	-4.53 percentage impairment Standard Deviation 20.707
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Absenteeism: Month 12	-11.94 percentage impairment Standard Deviation 30.569	-8.00 percentage impairment Standard Deviation 22.943
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Presenteeism: Month 6	-4.40 percentage impairment Standard Deviation 22.376	-8.48 percentage impairment Standard Deviation 28.903
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Presenteeism: Month 12	-8.75 percentage impairment Standard Deviation 22.472	-15.94 percentage impairment Standard Deviation 33.201
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Work Productivity Loss: Month 6	-9.67 percentage impairment Standard Deviation 25.096	-10.21 percentage impairment Standard Deviation 33.012
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Work Productivity Loss: Month 12	-14.87 percentage impairment Standard Deviation 30.538	-18.77 percentage impairment Standard Deviation 36.380
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Activity Impairment: Month 6	-6.19 percentage impairment Standard Deviation 27.670	-10.26 percentage impairment Standard Deviation 29.843
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Activity Impairment: Month 12	-5.81 percentage impairment Standard Deviation 24.870	-12.64 percentage impairment Standard Deviation 28.090

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: - 3	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: - 2	2 Participants	6 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: - 1	21 Participants	23 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: + 0	18 Participants	39 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: + 1	3 Participants	7 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: + 2	0 Participants	2 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 6: + 3	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: - 3	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: - 2	0 Participants	5 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: - 1	15 Participants	22 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: + 0	16 Participants	20 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: + 1	1 Participants	3 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: + 2	0 Participants	2 Participants
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Month 12: + 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=44 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 Participants 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.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: - 3	1 Participants	0 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: - 2	0 Participants	3 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: - 1	13 Participants	24 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: 0	26 Participants	45 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: + 1	3 Participants	5 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: + 2	1 Participants	0 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 6: + 3	0 Participants	0 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: - 3	0 Participants	0 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: - 2	3 Participants	4 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: - 1	15 Participants	17 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: 0	11 Participants	28 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: + 1	2 Participants	4 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: + 2	1 Participants	0 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Month 12: + 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=43 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=75 Participants 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.
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Month 6	-126.4 pg/mL Standard Deviation 621.45	-361.6 pg/mL Standard Deviation 626.56
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Month 12	-283.2 pg/mL Standard Deviation 571.86	-395.8 pg/mL Standard Deviation 752.83

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: 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.

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

Outcome measures

Measure	Randomized Treatment Cohort: Placebo n=43 Participants 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.	Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=75 Participants 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.
Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Month 6	-0.26 log pg/mL Standard Deviation 0.732	-0.50 log pg/mL Standard Deviation 0.557
Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Month 12	-0.46 log pg/mL Standard Deviation 0.761	-0.63 log pg/mL Standard Deviation 0.616

Adverse Events

Phase 1: Safety Cohort:12.5 M CDCs

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1: Safety Cohort: 25 M CDCs

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Phase 2: Randomized Treatment Cohort: Placebo

Serious events: 15 serious events

Other events: 24 other events

Deaths: 0 deaths

Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Serious events: 20 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase 1: Safety Cohort:12.5 M CDCs n=4 participants at risk 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.	Phase 1: Safety Cohort: 25 M CDCs n=10 participants at risk 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.	Phase 2: Randomized Treatment Cohort: Placebo n=44 participants at risk 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.	Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 participants at risk 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.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Angina Pectoris	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Atrial Fibrillation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Acute	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiogenic Shock	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Mitral Valve Incompetence	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Ventricular Tachycardia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Colitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Erosive Oesophagitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Chest Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Non-Cardiac Chest Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Influenza	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Pancreatitis Bacterial	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Angiogram	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Cervical Radiculopathy	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Dizziness	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Ischaemic Stroke	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Presyncope	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Syncope	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Pulmonary Embolism	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Surgical and medical procedures Implantable Defibrillator Insertion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.5% 5/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Surgical and medical procedures Implantable Icd Insertion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Intermittent Claudication	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.

Other adverse events

Measure	Phase 1: Safety Cohort:12.5 M CDCs n=4 participants at risk 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.	Phase 1: Safety Cohort: 25 M CDCs n=10 participants at risk 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.	Phase 2: Randomized Treatment Cohort: Placebo n=44 participants at risk 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.	Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells n=77 participants at risk 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.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	9.1% 4/44 • Number of events 6 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Left Ventricular Dysfunction	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Angina Pectoris	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Bradycardia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Pericarditis	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	7.8% 6/77 • Number of events 6 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Rectal Haemorrhage	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Chest Discomfort	50.0% 2/4 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Catheter Site Related Reaction	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Chest Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	13.6% 6/44 • Number of events 6 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.5% 5/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Drug Intolerance	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Mucosal Inflammation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Nasopharyngitis	25.0% 1/4 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Ear Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Furuncle	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Gastroenteritis Viral	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Implant Site Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Brain Contusion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Corneal Abrasion	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Foreign Body	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Wrist Fracture	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Troponin I Increased	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	13.6% 6/44 • Number of events 6 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.5% 5/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Dizziness	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Syncope	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Dizziness Postural	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Headache	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Depression	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Insomnia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Renal Failure Acute	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	9.1% 4/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	7.8% 6/77 • Number of events 6 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Productive Cough	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Urticaria	25.0% 1/4 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	10.0% 1/10 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Hypotension	25.0% 1/4 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	20.0% 2/10 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	11.4% 5/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.5% 5/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Blood and lymphatic system disorders Anaemia Macrocytic	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Angina Unstable	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Anginal Equivalent	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Atrial Fibrillation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Atrial Thrombosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Atrioventricular Block	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Atrioventricular Block First Degree	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Bradycardia And Hypotension	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Bundle Branch Block Left	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Aneurysm	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Acute	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Chronic	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Cardiac Ventricular Thrombosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Coronary Artery Dissection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Coronary Artery Thrombosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Intracardiac Thrombus	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Palpitations	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Sinus Bradycardia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Cardiac disorders Ventricular Tachycardia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Congenital, familial and genetic disorders Arteriovenous Malformation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Ear and labyrinth disorders Ear Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Ear and labyrinth disorders Mixed Deafness	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Ear and labyrinth disorders Vertigo	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Eye disorders Glaucoma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Eye disorders Hyphaema	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Ascites	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Constipation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Diverticulum	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Food Poisoning	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Melaena	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	5.2% 4/77 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Catheter Site Bruise	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Hernia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Malaise	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Non-Cardiac Chest Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Oedema	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Oedema Peripheral	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Peripheral Swelling	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Pyrexia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
General disorders Swelling	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Hepatobiliary disorders Hepatic Lesion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Bronchitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Cellulitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Folliculitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Hordeolum	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Influenza	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Onychomycosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Oral Herpes	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Otitis Media	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Pharyngitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Pneumonia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Rash Pustular	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Respiratory Tract Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Sinusitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Tinea Pedis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Tooth Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Urinary Tract Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Infections and infestations Viral Infection	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Laceration	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Procedural Hypotension	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Injury, poisoning and procedural complications Vascular Injury	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Pruritus Generalised	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Surgical and medical procedures Implantable Defibrillator Insertion	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Arteriovenous Fistula	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Deep Vein Thrombosis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Haematoma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.8% 3/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Hypertension	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Hypertensive Crisis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Intermittent Claudication	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Vascular disorders Orthostatic Hypotension	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations ALT Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations AST Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Blood Creatinine Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Blood Glucose Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Blood Potassium Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Blood Uric Acid Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Cardiac Murmur	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations ECG PR Prolongation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations ECG ST Segment Depression	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations ECG ST Segment Elevation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Ejection Fraction Decreased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Haematocrit Decreased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Haemoglobin Decreased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Liver Function Test Abnormal	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Mean Cell Haemoglobin Conc Dec	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Mean Cell Haemoglobin Decreased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Red Blood Cells Urine	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Red Cell Distribution Width Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Investigations Transaminases Increased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Fluid Retention	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Gout	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	6.5% 5/77 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Dupuytrens Contracture	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	11.4% 5/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Pain In Jaw	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Adenoma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Diabetic Neuropathy	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Ischaemic Stroke	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Paraesthesia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	3.9% 3/77 • Number of events 3 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Presyncope	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	4.5% 2/44 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Sciatica	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Nervous system disorders Sensory Disturbance	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Anxiety	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Libido Decreased	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Panic Attack	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Psychiatric disorders Suicidal Ideation	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Haematuria	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Nephrolithiasis	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Renal and urinary disorders Urinary Retention	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	11.4% 5/44 • Number of events 5 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/44 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.6% 2/77 • Number of events 2 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/77 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	0.00% 0/10 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	2.3% 1/44 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.	1.3% 1/77 • Number of events 1 • Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12) Analysis was performed on safety population.

Additional Information

Vice President of Clinical Research and Development Operations

Capricor, Inc.

Phone: 858-727-1755

Email: clinicaltrialsgov@capricor.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place