Supplementary appendixThis appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.
Supplement to: Patel AN, Henry TD, Quyyumi AA, et al, for the ixCELL-DCM Investigators. Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet 2016; published online April 4. http://dx.doi.org/10.1016/S0140-6736(16)30137-4.
Supplement Table 1. Primary endpoint: All-cause Death, Cardiovascular Hospitalizations or Unplanned Outpatient/ED Visits for Treatment of
Acute Decompensated Heart Failure modified ITT n=114. There were statistically significantly fewer events in the Ixmyelocel-T group compared
to the placebo group *(p = 0·0107, Poisson regression) Rate Ratio [95% CI]: 0·59 [0·40-0·89]· Sensitivity endpoint including the IP procedure
related events was positive *(p = 0·0082, Poisson regression) Rate Ratio [95% CI]: 0·58 [0·39-0·87].
_____Primary Endpoint_____
Without IP Procedure Related
Events
_____Sensitivity Endpoint_____
With IP Procedure Related Events
Control
(N=55)
Ixmyelocel-T
(N=59)
Control
(N=55)
Ixmyelocel-T
(N=59)
P-Valuea 0.0107 0.0082
Rate Ratio [95% CI] 0.59 [0.40, 0.89] 0.58 [0.39, 0.87]
Events/100 patient years 121.73 72.16 123.79 72.16
Patient years Exposed 48.5 55.4 48.5 55.4
Total Events 59 40 60 40
Distribution of Events by Patient, n
(%)
0 27 (49.1) 36 (61.0) 26 (47.3) 36 (61.0)
>=1 28 (50.9) 23 (39.0) 29 (52.7) 23 (39.0)
1 11 (20.0) 13 (22.0) 12 (21.8) 13 (22.0)
2 11 (20.0) 4 ( 6.8) 11 (20.0) 4 ( 6.8)
3 2 ( 3.6) 5 ( 8.5) 2 ( 3.6) 5 ( 8.5)
4 2 ( 3.6) 1 ( 1.7) 2 ( 3.6) 1 ( 1.7)
5 1 ( 1.8) 0 ( 0.0) 1 ( 1.8) 0 ( 0.0)
7 1 ( 1.8) 0 ( 0.0) 1 ( 1.8) 0 ( 0.0)
Supplement Figure 1. Kaplan-Meier Analysis: The secondary endpoint of time to first cardiovascular event of ixmyelocel-T versus
placebo modified ITT n=114 (p=0·1434, Cox Regression HR 0·66· (0·38-1·15) 95% CI.
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
202006 A612 Intraventricular
haemorrhage /
INTRAVENTRICULAR
HEMORRHAGE
2014-12-
18/ 79
0
A613 Respiratory failure /
RESPIRATORY
FAILURE
2014-12-
18/ 79
0
A454 Intracranial aneurysm /
RUPTURED DUAL
ANTERIOR
COMMUNICATING
ARTERY ANEURYSMS
2014-12-
18/ 79
Y 2014-12-20 Y 2014-12-18 2
A462 Subarachnoid haemorrhage
/ SUBARCHNOID
HEMORRHAGE
2014-12-
18/ 79
0
203002* A469 Thrombosis / BLOOD
CLOT
2015-01-
01/ 296
Y 2015-01-01 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 5 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
202006 A612 Intraventricular
haemorrhage /
INTRAVENTRICULAR
HEMORRHAGE
2014-12-20 2014-12-20
/ 81
NOT RELATED Y
A613 Respiratory failure /
RESPIRATORY
FAILURE
2014-12-20 2014-12-20
/ 81
NOT RELATED Y
A454 Intracranial aneurysm /
RUPTURED DUAL
ANTERIOR
COMMUNICATING
ARTERY ANEURYSMS
2014-12-20 2014-12-20
/ 81
NOT RELATED Y
A462 Subarachnoid haemorrhage
/ SUBARCHNOID
HEMORRHAGE
2014-12-20 2014-12-20
/ 81
NOT RELATED Y
203002* A469 Thrombosis / BLOOD
CLOT
2015-01-02 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 6 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
204001 A363 Cardiac failure acute /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2013-10-
28/ 35
Y Y 2013-10-28 1
A365 Cardiac failure /
DECOMPENSATED
HEART FAILURE
2013-12-
09/ 77
Y Y 2013-12-09 2014-07-25 1
205002 A394 Dehydration /
DEHYDRATION
2014-06-
19/ 93
Y 2014-06-19 1
205007 A524 Cardiac failure congestive /
WORSENING
CONGESTIVE HEART
FAILURE
2015-05-
10/ 243
Y 2015-06-24 Y 2015-06-20 2
207001 A347 Confusional state /
WORSENING
CONFUSION
2013-05-
31/ 45
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 7 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A338 Hypercalcaemia /
WORSENING OF
HYPERCALCEMIA
2013-05-
31/ 45
Y 2013-05-31 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 8 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
204001 A363 Cardiac failure acute /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2013-11-07 2014-07-25 /
305
NOT RELATED
A365 Cardiac failure /
DECOMPENSATED
HEART FAILURE
2013-12-23 2014-07-25 /
305
NOT RELATED
205002 A394 Dehydration /
DEHYDRATION
2014-06-20 NOT RELATED
205007 A524 Cardiac failure congestive /
WORSENING
CONGESTIVE HEART
FAILURE
2015-06-24 2015-06-24
/ 288
NOT RELATED
207001 A347 Confusional state /
WORSENING
CONFUSION
2013-06-06 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 9 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A338 Hypercalcaemia /
WORSENING OF
HYPERCALCEMIA
2013-06-06 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 10 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
210004 A597 Cardiac failure / ACUTE
ON CHRONIC SYSTOLIC
& DIASTOLIC HF
2014-05-
01/ 21
0
A381 Chest pain / CHEST PAIN 2014-05-
01/ 21
Y Y 2014-05-01 1
A391 Klebsiella bacteraemia /
KLEBSIELLA
BACTEREMIA
2014-05-
02/ 22
0
Cardiac failure / ACUTE
ON CHRONIC HF,
SYSTOLIC &
DIASTOLIC
2014-05-
15/ 35
0
A393 Hypotension /
HYPOTENSION
2014-06-
04/ 55
Y 2014-06-04 1
A398 Pneumonia /
PNEUMONIA
2014-06-
10/ 61
Y 2014-06-10 0
211004 A510 Sepsis / SEPSIS 2015/ Y 2015-05-06 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 11 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A571 Small intestinal obstruction
/ SMALL BOWEL
OBSTRUCTION
2015/ 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 12 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
210004 A597 Cardiac failure / ACUTE
ON CHRONIC SYSTOLIC
& DIASTOLIC HF
2014-05-13 NOT RELATED Y
A381 Chest pain / CHEST PAIN 2014-05-13 NOT RELATED
A391 Klebsiella bacteraemia /
KLEBSIELLA
BACTEREMIA
2014-05-13 NOT RELATED Y
Cardiac failure / ACUTE
ON CHRONIC HF,
SYSTOLIC &
DIASTOLIC
NOT RELATED Y
A393 Hypotension /
HYPOTENSION
2014-06-05 NOT RELATED
A398 Pneumonia /
PNEUMONIA
2014-06-15 NOT RELATED
211004 A510 Sepsis / SEPSIS 2015-05-06 2015-05-06
/ 323
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 13 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A571 Small intestinal obstruction
/ SMALL BOWEL
OBSTRUCTION
2015-05-06 2015-05-06
/ 323
NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 14 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
211006 A426 Chest pain / CHEST PAIN 2014-10-
24/ 121
Y 2014-10-24 1
A427 Cardiac failure / HEART
FAILURE
EXACERBATION
2014-11-
04/ 132
Y Y 2014-11-04 1
212001# A343 Pyrexia / FEVER,
UNKNOWN ETIOLOGY
2013-06-
16/ 12
Y 2013-06-18 0
A345 Cardiogenic shock /
CARDIOGENIC SHOCK
2013-06-
18/ 14
Y 2013-06-21 1
212004 A466 Multiple fractures /
MULTIPLE FRACTURES
2015-01-
04/ 250
Y 2015-01-04 0
A467 Respiratory distress /
RESPIRATORY
DISTRESS
2015-01-
08/ 254
0
A492 Metabolic encephalopathy /
METABOLIC
ENCEPHALOPATHY
2015-04-
13/ 349
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 15 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
211006 A426 Chest pain / CHEST PAIN 2014-10-29 NOT RELATED Y
A427 Cardiac failure / HEART
FAILURE
EXACERBATION
2014-11-14 NOT RELATED
212001# A343 Pyrexia / FEVER,
UNKNOWN ETIOLOGY
2013-06-21 2013-06-21
/ 17
UNLIKELY
A345 Cardiogenic shock /
CARDIOGENIC SHOCK
2013-06-21 2013-06-21
/ 17
UNLIKELY
212004 A466 Multiple fractures /
MULTIPLE FRACTURES
2015-01-18 NOT RELATED
A467 Respiratory distress /
RESPIRATORY
DISTRESS
2015-01-18 NOT RELATED Y
A492 Metabolic encephalopathy /
METABOLIC
ENCEPHALOPATHY
2015-05-01 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 16 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
212004 A491 Urinary tract infection /
URINARY TRACT
INFECTION
2015-04-
13/ 349
Y 2015-04-13 0
A493 Atrial fibrillation /
ATRIAL FIBRILLATION
WITH RAPID
VENTRICULAR RATE
2015-04-
15/ 351
0
A495 Renal failure acute /
ACUTE RENAL
FAILURE
2015-04-
16/ 352
0
A496 Coagulopathy /
COAGULOPATHY
2015-04-
16/ 352
0
A494 Septic shock / SEPTIC
SHOCK
2015-04-
16/ 352
0
A497 Ischaemic hepatitis /
SHOCK LIVER
2015-04-
16/ 352
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 17 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
212004 A491 Urinary tract infection /
URINARY TRACT
INFECTION
2015-05-01 NOT RELATED
A493 Atrial fibrillation /
ATRIAL FIBRILLATION
WITH RAPID
VENTRICULAR RATE
2015-05-01 NOT RELATED Y
A495 Renal failure acute /
ACUTE RENAL
FAILURE
2015-05-01 NOT RELATED Y
A496 Coagulopathy /
COAGULOPATHY
2015-05-01 NOT RELATED Y
A494 Septic shock / SEPTIC
SHOCK
2015-05-01 NOT RELATED Y
A497 Ischaemic hepatitis /
SHOCK LIVER
2015-05-01 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 18 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
212008 A464 Coronary artery disease /
WORSENING
CORONARY ARTERY
DISEASE
2015-01/ Y 2015-01-29 1
A545 Diarrhoea / DIARRHEA 2015-08-
12/ 357
Y 2015-09-01 0
213007 A382 Diabetic ketoacidosis /
DIABETIC
KETOACIDOSIS
2014-05-
07/ 7
Y 2014-05-07 1
215001 A349 Syncope / SYNCOPE 2013-07-
05/ 30
Y 2013-07-05 1
A354 Cardiac death / CARDIAC
DEATH
2013-07-
23/ 48
Y 2013-07-23 1
215002 A350 Ventricular fibrillation /
VENTRICULAR
FIBRILLATION
2013-07-
11/ 2
Y 2013-07-11 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 19 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
215009 A411 Cardiac failure congestive /
CHF EXACERBATION -
ACUTE ON CHRONIC
2014-09-
05/ 38
Y Y 2014-09-05 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 20 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
212008 A464 Coronary artery disease /
WORSENING
CORONARY ARTERY
DISEASE
2015-01-30 NOT RELATED
A545 Diarrhoea / DIARRHEA 2015-09-03 NOT RELATED
213007 A382 Diabetic ketoacidosis /
DIABETIC
KETOACIDOSIS
2014-05-09 NOT RELATED Y
215001 A349 Syncope / SYNCOPE 2013-07-10 2013-07-23
/ 48
UNLIKELY
A354 Cardiac death / CARDIAC
DEATH
2013-07-23
/ 48
UNLIKELY
215002 A350 Ventricular fibrillation /
VENTRICULAR
FIBRILLATION
2013-07-13 POSSIBLE
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 21 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
215009 A411 Cardiac failure congestive /
CHF EXACERBATION -
ACUTE ON CHRONIC
2014-09-07 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 22 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
215009 A459 Cardiac failure congestive /
ACUTE CONGESTIVE
HEART FAILURE
2014-11-
28/ 122
Y Y 2014-11-28 1
215013 A514 Dyspnoea / SOB 2015-05-
21/ 156
Y 2015-05-21 1
A587 Renal failure acute /
ACUTE KIDNEY INJURY
2015-11-
09/ 328
0
A586 Chest pain / ATYPICAL
CHEST PAIN
2015-11-
09/ 328
0
A584 Dizziness / DIZZINESS 2015-11-
09/ 328
Y 2015-11-09 1
217001 A366 Cardiac failure congestive /
ACUTE ON CHRONIC
SYSTOLIC
CONGESTIVE HEART
FAILURE
2013-11-
22/ 16
Y Y 2013-11-22 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 23 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A367 Cardiac failure /
WORSENING HEART
FAILURE
2013-12-
09/ 33
Y 2013-12-09 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 24 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
215009 A459 Cardiac failure congestive /
ACUTE CONGESTIVE
HEART FAILURE
2014-12-02 NOT RELATED
215013 A514 Dyspnoea / SOB 2015-05-23 NOT RELATED
A587 Renal failure acute /
ACUTE KIDNEY INJURY
2015-11-16 NOT RELATED Y
A586 Chest pain / ATYPICAL
CHEST PAIN
2015-11-16 NOT RELATED Y
A584 Dizziness / DIZZINESS 2015-11-16 NOT RELATED
217001 A366 Cardiac failure congestive /
ACUTE ON CHRONIC
SYSTOLIC
CONGESTIVE HEART
FAILURE
2013-11-25 2014-04-08
/ 153
NOT RELATED
A367 Cardiac failure /
WORSENING HEART
FAILURE
2013-12-10 2014-04-08
/ 153
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 25 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
217001 A369 Pyrexia / FEVER OF
UNKNOWN ORIGIN
2014-01-
08/ 63
Y 2014-01-08 0
A376 Septic shock / SEPTIC
SHOCK
2014-04-
01/ 146
Y 2014-04-08 Y Y 2014-04-01 2
220006 A477 Cardiac failure congestive /
WORSENING CHF
2015-03-
03/ 250
Y Y 2015-03-04 1
220008 A519 Acute coronary syndrome /
ACUTE CORONARY
SYNDROME
2015-05-
20/ 237
Y 2015-05-20 1
220009 A499 Acute myocardial
infarction / NON-ST
ELEVATION
MYOCARDIAL
INFARCTION
2015-03-
24/ 98
Y 2015-03-24 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 26 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
217001 A369 Pyrexia / FEVER OF
UNKNOWN ORIGIN
2014-01-27 2014-04-08
/ 153
NOT RELATED
A376 Septic shock / SEPTIC
SHOCK
2014-04-07 2014-04-08
/ 153
NOT RELATED
220006 A477 Cardiac failure congestive /
WORSENING CHF
2015-03-08 NOT RELATED
220008 A519 Acute coronary syndrome /
ACUTE CORONARY
SYNDROME
2015-05-21 NOT RELATED
220009 A499 Acute myocardial
infarction / NON-ST
ELEVATION
MYOCARDIAL
INFARCTION
2015-03-27 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 27 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
221001 A425 Road traffic accident /
MANUBRIAL
FRACTURE
SECONDARY TO
MOTOR VEHICLE
ACCIDENT
2014-11-
06/ 268
Y 2014-11-06 0
221004 A504 Hypotension /
HYPOTENSION
2014-10-
09/ 1
0
A623 Cardiac failure congestive /
CONGESTIVE HEART
FAILURE
EXACERBATION
2014-10-
10/ 2
0
A505 Urinary tract infection /
URINARY TRACT
INFECTION
2014-10-
10/ 2
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 28 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
225001 A386 Cardiac perforation /
PERFORATION
REQUIRING SURGICAL
INTERVENTION
2014-05-
21/ 1
0
227002 A517 Hypotension /
HYPOTENSION
2015-04-
02/ 190
Y 2015-04-06 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 29 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
221001 A425 Road traffic accident /
MANUBRIAL
FRACTURE
SECONDARY TO
MOTOR VEHICLE
ACCIDENT
2014-11-07 NOT RELATED
221004 A504 Hypotension /
HYPOTENSION
2014-10-15 POSSIBLE Y
A623 Cardiac failure congestive /
CONGESTIVE HEART
FAILURE
EXACERBATION
2014-10-15 POSSIBLE Y
A505 Urinary tract infection /
URINARY TRACT
INFECTION
2014-10-15 UNLIKELY Y
225001 A386 Cardiac perforation /
PERFORATION
REQUIRING SURGICAL
INTERVENTION
2014-05-24 DEFINITE Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 30 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
227002 A517 Hypotension /
HYPOTENSION
2015-04-08 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 31 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
228002 A395 Angina unstable /
UNSTABLE ANGINA
2014-06-
23/ 117
Y 2014-06-23 1
A405 Angina unstable /
UNSTABLE ANGINA
2014-08-
21/ 176
Y 2014-08-21 1
A456 Angina unstable /
UNSTABLE ANGINA
2015-01-
08/ 316
Y 2015-01-08 1
228003* A421 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
HYPOKALEMIA
2014-10-
06/ 110
Y 2014-10-06 1
A451 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2014-12-
16/ 181
Y 2014-12-16 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 32 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A476 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
HYPOKALEMIA
2015-03-
05/ 260
Y 2015-03-05 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 33 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
228002 A395 Angina unstable /
UNSTABLE ANGINA
2014-06-25 NOT RELATED Y
A405 Angina unstable /
UNSTABLE ANGINA
2014-08-22 NOT RELATED Y
A456 Angina unstable /
UNSTABLE ANGINA
2015-01-10 NOT RELATED Y
228003* A421 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
HYPOKALEMIA
2014-10-07 NOT RELATED
A451 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2014-12-16 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 34 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A476 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
HYPOKALEMIA
2015-03-06 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 35 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
228003* A483 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA 2ND TO
HYPOKALEMIA
2015-04-
02/ 288
Y 2015-04-02 1
A485 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
COCAINE ABUSE
2015-04-
03/ 289
Y 2015-04-03 1
A490 Chest pain / CHEST PAIN
WITH PALPITATIONS
2015-04-
07/ 293
Y 2015-04-07 1
A503 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-
07/ 323
Y Y 2015-05-07 1
231001 A400 Gout / ACUTE GOUT
ATTACK LEADS TO
HOSPITALIZATION
2014-07-
01/ 103
Y 2014-07-01 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 36 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A404 Renal failure acute /
ACUTE KIDNEY INJURY
2014-07-
01/ 103
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 37 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
228003* A483 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA 2ND TO
HYPOKALEMIA
2015-04-03 NOT RELATED
A485 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
SECONDARY TO
COCAINE ABUSE
2015-04-07 NOT RELATED
A490 Chest pain / CHEST PAIN
WITH PALPITATIONS
2015-04-08 NOT RELATED
A503 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-12 NOT RELATED
231001 A400 Gout / ACUTE GOUT
ATTACK LEADS TO
HOSPITALIZATION
2014-07-04 2014-09-23
/ 187
NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 38 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A404 Renal failure acute /
ACUTE KIDNEY INJURY
2014-07-04 2014-09-23
/ 187
NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 39 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
231001 A401 Ventricular tachycardia / V-
TACH
2014-07-
04/ 106
Y 2014-07-04 1
A457 Cardiac failure /
WORSENING HEART
FAILURE
2014-07-
04/ 106
0
A412 Cardiac failure /
EXACERBATION OF
HEART FAILURE
2014-09-
09/ 173
Y Y 2014-09-09 1
A414 Urinary tract infection /
UTI
2014-09-
16/ 180
Y 2014-09-23 Y 2014-09-19 2
A567 Cardiogenic shock /
CARDIOGENIC SHOCK
2014-09-
22/ 186
Y 2014-09-19 0
231006 A458 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2014-11-
02/ 25
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 40 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A433 Acute myocardial
infarction / NSTEMI
2014-11-
02/ 25
Y 2014-11-02 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 41 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
231001 A401 Ventricular tachycardia / V-
TACH
2014-07-15 2014-09-23
/ 187
NOT RELATED
A457 Cardiac failure /
WORSENING HEART
FAILURE
2014-07-15 2014-09-23
/ 187
NOT RELATED Y
A412 Cardiac failure /
EXACERBATION OF
HEART FAILURE
2014-09-15 2014-09-23
/ 187
NOT RELATED
A414 Urinary tract infection /
UTI
2014-09-23 2014-09-23
/ 187
NOT RELATED
A567 Cardiogenic shock /
CARDIOGENIC SHOCK
2014-09-23 2014-09-23
/ 187
NOT RELATED
231006 A458 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2014-11-04 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 42 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A433 Acute myocardial
infarction / NSTEMI
2014-11-04 UNLIKELY Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 43 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
231006 A559 Cerebrovascular accident /
STROKE
2015-07-
19/ 284
Y 2015-07-19 1
231014 A564 Fall / FALL AT HOME 2014-12-
16/ 27
Y 2014-12-16 0
A472 Chest pain / CHEST PAIN
SECONDARY TO MICRO
VASCULAR DISEASE
2015-02-
14/ 87
Y 2015-02-14 1
A568 Chest pain / CHEST PAIN 2015-03-
09/ 110
Y 2015-03-09 1
A592 Hypokalaemia / SEVERE
HYPOKALEMIA
2015-03-
09/ 110
0
A569 Chest pain / CHEST PAIN 2015-06-
13/ 206
Y 2015-06-15 1
A570 Cardiac failure / ACUTE
ON CHRONIC SYSTOLIC
HEART FAILURE
2015-09-
02/ 287
Y 2015-09-02 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 44 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A590 Chest pain / CHEST PAIN 2015-09-
02/ 287
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 45 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
231006 A559 Cerebrovascular accident /
STROKE
2015-07-21 NOT RELATED Y
231014 A564 Fall / FALL AT HOME 2014-12-18 NOT RELATED
A472 Chest pain / CHEST PAIN
SECONDARY TO MICRO
VASCULAR DISEASE
2015-02-16 NOT RELATED
A568 Chest pain / CHEST PAIN 2015-03-11 NOT RELATED
A592 Hypokalaemia / SEVERE
HYPOKALEMIA
2015-03-11 NOT RELATED Y
A569 Chest pain / CHEST PAIN 2015-06-16 NOT RELATED
A570 Cardiac failure / ACUTE
ON CHRONIC SYSTOLIC
HEART FAILURE
2015-09-05 NOT RELATED
A590 Chest pain / CHEST PAIN 2015-09-05 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 46 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
233002 A406 Non-cardiac chest pain /
NON-CARDIAC CHEST
PAIN
2014-07-
11/ 16
Y 2014-07-11 1
A596 Angina unstable /
UNSTABLE ANGINA
2015-05-
31/ 340
Y 2015-05-31 1
235001 A546 Cardiac failure congestive /
ACUTE ON CHRONIC
CHF
2015-07/ Y Y 2015-08-02 1
A594 Hypotension /
HYPOTENSION
2014-08-
14/ 1
0
A595 Bronchopneumonia /
MULTILOBAR
BRONCHOPNEUMONIA
2015-03-
26/ 225
Y Y 2015-03-29 1
237001 A431 Cardiac failure /
WORSENING HEART
FAILURE
2014-09-
16/ 105
Y Y 2014-09-16 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 47 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A487 Cardiac failure /
WORSENING HEART
FAILURE
2015-03-
30/ 300
Y 2015-04-04 Y Y 2015-03-30 2
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 48 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
233002 A406 Non-cardiac chest pain /
NON-CARDIAC CHEST
PAIN
2014-07-12 NOT RELATED
A596 Angina unstable /
UNSTABLE ANGINA
2015-06-01 NOT RELATED
235001 A546 Cardiac failure congestive /
ACUTE ON CHRONIC
CHF
2015-08-04 NOT RELATED
A594 Hypotension /
HYPOTENSION
PROBABLE Y
A595 Bronchopneumonia /
MULTILOBAR
BRONCHOPNEUMONIA
2015-03-31 NOT RELATED
237001 A431 Cardiac failure /
WORSENING HEART
FAILURE
2014-09-21 2015-04-04
/ 305
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 49 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A487 Cardiac failure /
WORSENING HEART
FAILURE
2015-04-04 2015-04-04
/ 305
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 50 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
237001 A572 Acute respiratory failure /
ACUTE RESPIRATORY
FAILURE
2015-03-
31/ 301
0
A516 Pulseless electrical activity
/ PULSELESS
ELECTRICAL ACTIVITY
2015-03-
31/ 301
0
A549 Cardio-respiratory arrest /
CARDIOPULMONARY
ARREST
2015-04-
04/ 305
0
237002 A468 Syncope / SYNCOPAL
EPISODE SECONDARY
TO ELECTROLYTE
IMBALANCE
2014-12-
11/ 140
Y 2014-12-11 1
A515 Ventricular fibrillation /
VENTRICULAR
FIBRILLATION
2014-12-
11/ 140
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 51 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
237001 A572 Acute respiratory failure /
ACUTE RESPIRATORY
FAILURE
2015-04-03 2015-04-04
/ 305
NOT RELATED Y
A516 Pulseless electrical activity
/ PULSELESS
ELECTRICAL ACTIVITY
2015-04-04 2015-04-04
/ 305
NOT RELATED Y
A549 Cardio-respiratory arrest /
CARDIOPULMONARY
ARREST
2015-04-04
/ 305
NOT RELATED Y
237002 A468 Syncope / SYNCOPAL
EPISODE SECONDARY
TO ELECTROLYTE
IMBALANCE
2014-12-13 NOT RELATED
A515 Ventricular fibrillation /
VENTRICULAR
FIBRILLATION
2014-12-13 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 52 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
237007 A465 Bronchitis / BRONCHITIS 2014-12-
14/ 40
Y 2014-12-14 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 53 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Control
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
237007 A465 Bronchitis / BRONCHITIS 2014-12-16 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 54 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
201009 A593 Osteoarthritis / LEFT
KNEE DEGENERATIVE
JOINT DISEASE
2014-12-
17/ 44
Y 2014-12-17 0
202004 A500 Cardiac failure chronic /
WORSENING HEART
FAILURE
2015-02-
25/ 181
Y 2015-04-20 2015-04-21 1
A563 Fluid overload / VOLUME
OVERLOAD
2015-04-
22/ 237
0
204003 A543 Gastrointestinal
haemorrhage /
GASTROINTESTINAL
BLEED
2015-08/ 0
A562 Cardiac failure chronic /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2015-08-
25/ 208
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 55 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A544 Small intestine carcinoma /
DUODENAL
CARCINOID
2015-08-
26/ 209
Y 2015-08-22 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 56 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
201009 A593 Osteoarthritis / LEFT
KNEE DEGENERATIVE
JOINT DISEASE
2014-12-19 NOT RELATED
202004 A500 Cardiac failure chronic /
WORSENING HEART
FAILURE
2015-05-08 2015-04-22
/ 237
NOT RELATED
A563 Fluid overload / VOLUME
OVERLOAD
2015-05-08 2015-04-22
/ 237
NOT RELATED Y
204003 A543 Gastrointestinal
haemorrhage /
GASTROINTESTINAL
BLEED
2015-08-28 NOT RELATED Y
A562 Cardiac failure chronic /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2015-08-28 NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 57 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A544 Small intestine carcinoma /
DUODENAL
CARCINOID
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 58 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
204003 A557 Gastrointestinal
haemorrhage /
GASTROINTESTINAL
BLEED
2015-09-
25/ 239
Y 2015-09-28 0
205001 A392 Gastroenteritis viral /
VIRAL
GASTROENTERITIS
2014-04-
20/ 54
Y 2014-04-20 0
207002 A330 Nephropathy toxic /
CONTRAST DYE
INDUCED
NEPHROPATHY
2013-04-
19/ 2
Y 2013-04-19 0
Dyspnoea / WORSENING
SHORTNESS OF
BREATH
2013-04-
29/ 12
2013-04-29 1
A333 Renal failure acute /
ACUTE KIDNEY INJURY
2013-05-
27/ 40
Y 2013-05-27 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 59 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A348 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2013-07-
04/ 78
Y Y 2013-07-04 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 60 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
204003 A557 Gastrointestinal
haemorrhage /
GASTROINTESTINAL
BLEED
2015-10-04 NOT RELATED
205001 A392 Gastroenteritis viral /
VIRAL
GASTROENTERITIS
2014-04-21 NOT RELATED
207002 A330 Nephropathy toxic /
CONTRAST DYE
INDUCED
NEPHROPATHY
2013-04-23 DEFINITE
Dyspnoea / WORSENING
SHORTNESS OF
BREATH
NOT RELATED
A333 Renal failure acute /
ACUTE KIDNEY INJURY
2013-06-01 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 61 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A348 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2013-07-11 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 62 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
207002 A355 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
EXACERBATION
2013-07-
24/ 98
Y 2013-07-25 1
207004 A378 Pericardial effusion /
PERICARDIAL
EFFUSION
2014-04-
10/ 1
0
A379 Cardiac tamponade /
CARDIAC TAMPONADE
2014-04-
20/ 11
Y 2014-04-20 1
208001 A410 Syncope / SYNCOPE AND
COLLAPSE
2014-08-
24/ 201
Y 2014-08-29 1
210003 A621 Hypotension /
HYPOTENSION
2014-04-
02/ 1
0
A375 Femoral artery dissection /
RIGHT FEMORAL
DISSECTION
2014-04-
02/ 1
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 63 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A547 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-04-
01/ 365
Y Y 2015-04-01 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 64 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
207002 A355 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
EXACERBATION
2013-07-29 NOT RELATED
207004 A378 Pericardial effusion /
PERICARDIAL
EFFUSION
2014-04-15 DEFINITE Y
A379 Cardiac tamponade /
CARDIAC TAMPONADE
2014-04-25 PROBABLE
208001 A410 Syncope / SYNCOPE AND
COLLAPSE
2014-09-10 NOT RELATED
210003 A621 Hypotension /
HYPOTENSION
2014-04-06 POSSIBLE Y
A375 Femoral artery dissection /
RIGHT FEMORAL
DISSECTION
2014-04-06 DEFINITE Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 65 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A547 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-04-14 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 66 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
211002 A509 Peripheral vascular disorder
/ WORSENING PVD
2014-08-
04/ 91
0
A449 Osteomyelitis / LEFT
FOOT OSTEOMYELITIS
2014-12-
11/ 220
Y 2014-12-11 1
211007 A488 Dehydration /
DEHYDRATION
2015-04-
07/ 188
Y 2015-04-07 1
212002 A370 Influenza / INFLUENZA A 2014-01-
24/ 227
Y 2014-01-26 0
212006 A536 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-
09/ 284
Y 2015-05-09 1
A542 Gastrointestinal
haemorrhage / GI BLEED
2015-06-
30/ 336
Y 2015-06-30 0
215003 A388 Renal failure chronic /
ESKD
2013-12-
30/ 83
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 67 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A368 Cardiac failure /
WORSENING HEART
FAILURE
2013-12-
30/ 83
Y Y 2013-12-30 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 68 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
211002 A509 Peripheral vascular disorder
/ WORSENING PVD
2014-09-09 NOT RELATED Y
A449 Osteomyelitis / LEFT
FOOT OSTEOMYELITIS
2014-12-30 NOT RELATED
211007 A488 Dehydration /
DEHYDRATION
2015-04-11 NOT RELATED
212002 A370 Influenza / INFLUENZA A 2014-01-30 NOT RELATED Y
212006 A536 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-11 NOT RELATED
A542 Gastrointestinal
haemorrhage / GI BLEED
2015-07-04 NOT RELATED
215003 A388 Renal failure chronic /
ESKD
2014-01-11 NOT RELATED Y
A368 Cardiac failure /
WORSENING HEART
FAILURE
2014-01-11 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 69 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
215004 A384 Cardiac failure congestive /
CHF EXACERBATION
2014-04-
10/ 128
Y Y 2014-04-10 1
A383 Acute myocardial
infarction / ACUTE NON-
ST ELEVATION
MYOCARDIAL
INFARCTION
2014-04-
26/ 144
Y 2014-04-26 1
215007 A407 Supraventricular
tachycardia /
RECURRENT
SUPRAVENTRICULAR
TACHYCARDIA
2014-08-
20/ 71
Y 2014-08-20 1
A471 Coronary artery disease /
WORSENING
CORONARY ARTERY
DISEASE
2015-01-
18/ 222
Y 2015-01-18 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 70 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
220007 A533 Cardiac failure congestive /
WORSENING CHF -
CONGESTIVE HEART
FAILURE
2015-06-
03/ 272
Y 2015-06-11 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 71 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
215004 A384 Cardiac failure congestive /
CHF EXACERBATION
2014-04-12 NOT RELATED
A383 Acute myocardial
infarction / ACUTE NON-
ST ELEVATION
MYOCARDIAL
INFARCTION
2014-04-30 NOT RELATED Y
215007 A407 Supraventricular
tachycardia /
RECURRENT
SUPRAVENTRICULAR
TACHYCARDIA
2014-08-23 NOT RELATED
A471 Coronary artery disease /
WORSENING
CORONARY ARTERY
DISEASE
2015-01-30 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 72 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
220007 A533 Cardiac failure congestive /
WORSENING CHF -
CONGESTIVE HEART
FAILURE
2015-06-12 NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 73 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point a221005 A489 Myocardial infarction /
NON-Q-WAVE
MYOCARDIAL
INFARCTION
2015-04-
10/ 165
Y 2015-04-10 1
A511 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-
18/ 203
Y 2015-05-18 1
A539 Cardiogenic shock /
CARDIOGENIC SHOCK
DUE TO VENTRICULAR
TACHYCARDIA
2015-05-
20/ 205
Y 2015-05-18 1
A520 Ventricular tachycardia /
INCESSANT
RECURRING
VENTRICULAR
TACHYCARDIA
2015-06-
03/ 219
Y 2015-06-16 Y Y 2015-06-03 2015-06-07 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 74 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A540 Ventricular tachycardia /
MONOMORPHIC
VENTRICULAR
TACHYCARDIA
2015-06-
04/ 220
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 75 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event a221005 A489 Myocardial infarction /
NON-Q-WAVE
MYOCARDIAL
INFARCTION
2015-04-12 2015-06-16
/ 232
2015-06-09
/ 225
NOT RELATED Y
A511 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-29 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE
A539 Cardiogenic shock /
CARDIOGENIC SHOCK
DUE TO VENTRICULAR
TACHYCARDIA
2015-05-29 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE
A520 Ventricular tachycardia /
INCESSANT
RECURRING
VENTRICULAR
TACHYCARDIA
2015-06-07 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 76 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A540 Ventricular tachycardia /
MONOMORPHIC
VENTRICULAR
TACHYCARDIA
2015-06-07 2015-06-16
/ 232
2015-06-09
/ 225
NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 77 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
221007 A599 Pneumonia /
PNEUMONIA
2015-12-
15/ 364
Y Y 2015-12-18 0
222003 A439 Ischaemic stroke / ACUTE
ISCHEMIC INFARCT
2014-11-
18/ 153
Y 2014-11-19 1
222006 A442 Cardiogenic shock /
CARDIOGENIC SHOCK
2014-12-
04/ 64
Y Y 2014-12-04 1
A482 Cardiac failure /
DECOMPENSATED
HEART FAILURE
2015-01-
31/ 122
Y Y 2015-01-31 2015-03-06 1
a221005 A541 Cardiac arrest / CARDIAC
ARREST DUE TO
VENTRICULAR
TACHYCARDIA AND
VENTRICULAR
FIBRILLATION
2015-06-
09/ 225
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 78 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A598 Cardiac arrest / CARDIAC
ARREST DUE TO
VENTRICULAR
TACHYCARDIA
2015-06-
12/ 228
0
A522 Cardiogenic shock /
CARDIOGENIC SHOCK
2015-06-
16/ 232
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 79 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
221007 A599 Pneumonia /
PNEUMONIA
2015-12-20 POSSIBLE
222003 A439 Ischaemic stroke / ACUTE
ISCHEMIC INFARCT
2014-11-20 NOT RELATED Y
222006 A442 Cardiogenic shock /
CARDIOGENIC SHOCK
2014-12-08 2015-03-06 /
156
NOT RELATED
A482 Cardiac failure /
DECOMPENSATED
HEART FAILURE
2015-03-16 2015-03-06 /
156
NOT RELATED
a221005 A541 Cardiac arrest / CARDIAC
ARREST DUE TO
VENTRICULAR
TACHYCARDIA AND
VENTRICULAR
FIBRILLATION
2015-06-16 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 80 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A598 Cardiac arrest / CARDIAC
ARREST DUE TO
VENTRICULAR
TACHYCARDIA
2015-06-16 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE Y
A522 Cardiogenic shock /
CARDIOGENIC SHOCK
2015-06-16 2015-06-16
/ 232
2015-06-09
/ 225
POSSIBLE Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 81 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
223002 Fluid overload / CHF
FLUID OVERLOAD
2014-03-
31/ 14
2014-03-31 1
A387 Chest pain / CHEST PAIN 2014-04-
26/ 40
Y 2014-04-26 1
A452 Chest pain / CHEST PAIN 2014-05-
01/ 45
Y 2014-05-01 1
A453 Syncope / SYNCOPE 2014-06-
17/ 92
Y 2014-06-17 1
224003 A618 Ventricular tachycardia /
RECURRENT
VENTRICULAR
TACHYCARDIA
2015-12/ 0
A523 Cardiac failure /
WORSENING HEART
FAILURE
2015-05-
12/ 104
Y 2015-05-12 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 82 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A608 Cardiac failure /
WORSENING HEART
FAILURE
2015-11-
30/ 306
Y 2016-01-03 Y 2015-11-30 2
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 83 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
223002 Fluid overload / CHF
FLUID OVERLOAD
NOT RELATED
A387 Chest pain / CHEST PAIN 2014-04-29 NOT RELATED
A452 Chest pain / CHEST PAIN 2014-05-02 NOT RELATED
A453 Syncope / SYNCOPE 2014-06-22 NOT RELATED Y
224003 A618 Ventricular tachycardia /
RECURRENT
VENTRICULAR
TACHYCARDIA
2016-01-03 2016-01-03
/ 340
NOT RELATED Y
A523 Cardiac failure /
WORSENING HEART
FAILURE
2015-05-14 2016-01-03
/ 340
NOT RELATED
A608 Cardiac failure /
WORSENING HEART
FAILURE
2016-01-03 2016-01-03
/ 340
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 84 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
228007 A538 Femur fracture /
FRACTURED FEMUR
2015-07-
17/ 295
Y 2015-07-17 0
A573 Coagulopathy /
COUMADIN INDUCED
COAGULOPATHY
2015-08-
21/ 330
Y 2015-08-21 0
229002 A486 Ventricular tachycardia /
PAROXSYMAL
VENTRICULAR
TACHYCARDIA
(TERMINATED BY ICD)
WHICH
CORRESPONDED TO
PATIENT'S SYNCOPAL
EPISODE
2015-04-
05/ 109
Y Y 2015-04-05 1
A498 Cardiac failure acute /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2015-04-
13/ 117
Y Y 2015-04-15 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 85 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A513 Cardiac failure congestive /
CONGESTIVE HEART
FAILURE
2015-05-
15/ 149
Y 2015-05-15 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 86 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
228007 A538 Femur fracture /
FRACTURED FEMUR
2015-07-20 NOT RELATED
A573 Coagulopathy /
COUMADIN INDUCED
COAGULOPATHY
2015-08-23 NOT RELATED
229002 A486 Ventricular tachycardia /
PAROXSYMAL
VENTRICULAR
TACHYCARDIA
(TERMINATED BY ICD)
WHICH
CORRESPONDED TO
PATIENT'S SYNCOPAL
EPISODE
2015-04-08 2015-05-15
/ 149
NOT RELATED
A498 Cardiac failure acute /
ACUTE ON CHRONIC
SYSTOLIC HEART
FAILURE
2015-04-27 2015-05-15
/ 149
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 87 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A513 Cardiac failure congestive /
CONGESTIVE HEART
FAILURE
2015-05-15
/ 149
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 88 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
231012 Fluid overload /
VOLUME/FLUID
OVERLOAD
2015-09-
28/ 321
0
A580 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-10-
27/ 350
Y Y 2015-10-27 1
231013 A475 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-02-
22/ 67
Y Y 2015-02-26 1
A479 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-03-
12/ 85
Y Y 2015-03-17 1
A484 Cardiogenic shock /
CARDIOGENIC SHOCK
2015-03-
30/ 103
Y Y 2015-03-31 2015-04-21 1
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 89 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
A532 Haemorrhage intracranial /
INTRACRANIAL
HEMORRHAGE
2015-07-
10/ 205
Y 2015-07-11 Y 2015-07-10 0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 90 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
231012 Fluid overload /
VOLUME/FLUID
OVERLOAD
NOT RELATED Y
A580 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-10-31 NOT RELATED
231013 A475 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-03-09 2015-07-11
/ 206
2015-04-21
/ 125
NOT RELATED
A479 Cardiac failure acute /
ACUTE
DECOMPENSATED
HEART FAILURE
2015-03-25 2015-07-11
/ 206
2015-04-21
/ 125
NOT RELATED
A484 Cardiogenic shock /
CARDIOGENIC SHOCK
2015-05-08 2015-07-11
/ 206
2015-04-21
/ 125
NOT RELATED
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 91 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
A532 Haemorrhage intracranial /
INTRACRANIAL
HEMORRHAGE
2015-07-11 2015-07-11
/ 206
2015-04-21
/ 125
NOT RELATED Y
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 92 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
231015* A512 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-05-
05/ 97
Y Y 2015-05-05 1
A610 Cardiac failure / ACUTE
SYSTOLIC HEART
FAILURE
2015-05-
13/ 105
Y Y 2015-05-13 1
A606 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
2015-05-
13/ 105
0
A609 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
ARREST
2015-05-
18/ 110
0
A566 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-09-
07/ 222
0
Protocol ixCELL-55-1202-1 Top Line Report
Listing 16.2.6.1 Adjudication Events (Treated Set)
CV = Cardiovascular, HF= Heart Failure, HT= Heart Transplant, LVAD= Left Ventricular Assist Device, UNK = Unknown, MI = Myocardiac Infarction
*Patients excluded from Full Analysis Set for the Primary End Point analysis, but included in the sensitivity analysis for the Treated Set.
#Excluded from all Full Analysis Set efficacy analyses and Treated Set sensitivity analysis. a The 2015-05-18 hospitalization for Subjid 221005 is adjudicated as CV Hospitalization for both events, but will only be counted once in the Primary End Point analysis.
Vericel Corporation CONFIDENTIAL Page 93 of 103
Program: S:\Clinical\ABI World\1202\analysis\tlr\createtlf\l_adae_adj.sas Output: S:\Clinical\ABI World\1202\analysis\tlr\tlf\l_16.2.6.1_l_adae_adj.rtf
Data: S:\Clinical\ABI World\1202\analysis\tlr\statdata\adam\adae Database snapshot date: 01MAR2016 / Output run time: 03MAR2016:14:56:32
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
231015* A512 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-05-10 NOT RELATED
A610 Cardiac failure / ACUTE
SYSTOLIC HEART
FAILURE
2015-05-28 NOT RELATED
A606 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
NOT RELATED Y
A609 Ventricular tachycardia /
VENTRICULAR
TACHYCARDIA
ARREST
2015-05-28 NOT RELATED Y
A566 Cardiac failure congestive /
EXACERBATION OF
CONGESTIVE HEART
FAILURE
2015-09-13 NOT RELATED Y
Actual Treatment: Ixmyelocel-T
Start Adjudication Results Prim
Subject SAE Preferred/ Date/ Death Hospitalization ED/OP Date End
ID No. Investigator Term Day CV Non-CV UNK Date CV Non-CV HF Date HF HT LVAD Point
233006 A438 Cardiac failure congestive /
WORSENING CHF
2014-11-
21/ 2
Y 2014-11-20 1
235002 A434 Chest pain / CHEST PAIN
(ON LEFT SIDE)
2014-11-
06/ 92
Y 2014-11-10 1
Actual Treatment: Ixmyelocel-T
Subject SAE Preferred /
Hospital
Discharge Un-adjudicated Dates / Study Day
Related to
Catheterization- Additional Adjudication Results
ID No. Investigator Term Date Death LVAD HT Injection Procedure MI Non-fatal Stroke No Event
233006 A438 Cardiac failure congestive /
WORSENING CHF
2014-11-22 NOT RELATED
235002 A434 Chest pain / CHEST PAIN
(ON LEFT SIDE)
2014-11-11 NOT RELATED
IxCELL-DCM Trial Investigators
R. David Anderson, MD
University of Florida
Gainesville, FL
Adam Berman, MD
Georgia Regents University
Augusta, GA
Eugene Chung, MD
The Christ Hospital Lindner Center for Research and Education
Cincinnati, OH
Anthony DeMaria, MD
University of California, San Diego
San Diego, CA
Nabil Dib, MD
Mercy Gilbert Medical Center
Phoenix, AZ
Cara East, MD
Clinical Cardiovascular Research Center
Baylor University Medical Center
Dallas, TX
F. David Fortuin, MD
Mayo Clinic
Phoenix, AZ
Jon George, MD
Temple University School of Medicine
Philadelphia, PA
Joshua Hare, MD
University of Miami Miller School of Medicine
Miami, FL
David Henderson, MD
Cardiology Research Associates
Daytona Beach, FL
Timothy Henry, MD
Cedars-Sinai Heart Institute
Los Angeles, CA
Paul Huang, MD
Swedish Medical Center
Seattle, WA
Safwan Kassas, MD
Michigan Cardiovascular Institute
Saginaw, MI
Frank McGrew, MD
Stern Cardiovascular Foundation
Germantown, TN
Kimberly Parks, DO
Massachusetts General Hospital
Boston, MA
Amit N Patel, MD MS
University of Utah School of Medicine
Salt Lake City, UT
Sumanth Prabhu, MD
University of Alabama at Birmingham School of Medicine
Birmingham, AL
Rajan Patel, MD
Ochsner Medical Center
New Orleans, LA
Arshed Quyyumi, MD
Emory University School of Medicine
Atlanta, GA
Amish Raval, MD
University of Wisconsin School of Medicine and Public Health
Madison, WI
Guy Reeder, MD
Alfredo Clavell, MD
Mayo Clinic
Rochester, MN
Gary Schaer, MD
Rush University Medical Center
Chicago, IL
Richard Schatz, MD
Scripps Clinic
San Diego, CA
David Schmidt, MD
St. John’s Regional Medical Center
Oxnard, CA
P. Christian Schulze, MD, PhD
Columbia University
New York, NY
Catalin Toma, MD
University of Pittsburgh Medical Center
Pittsburgh, PA
Barry Trachtenberg, MD
Houston Methodist Hospital
Houston, TX
Mark Zucker, MD
Newark Beth Israel Medical Center
Newark, NJ
Participating Investigators who did not randomize any patients into the ixCELL-DCM trial:
Joe Wu, MD, PhD
Stanford University School of Medicine
Stanford, CA
(Screened 2 patients)
Guilherme Oliveira, MD
University Hospitals Case Medical Center
Cleveland, OH
(Screened 2 patients)
Hung Ly, MD
Montreal Heart Institute
Montreal, Quebec, Canada
(Screened 1 patient)
Robert Welsh, MD
University of Alberta
Edmonton, Alberta, Canada
(Screened 0 patients)
Dropped out of Trial:
David Feldman, MD
Minneapolis Heart Institute
Minneapolis, MN
IxCELL-DCM Study Steering Committee
Amit N. Patel, MD MS– Steering Committee Chairman
Associate Professor, Division of Cardiothoracic Surgery
University of Utah School of Medicine
Director, Clinical Regenerative Medicine and Tissue Engineering
University of Utah
Timothy D. Henry, MD - PI
Department of Medicine
Director, Division of Cardiology
Lee and Harold Kapelovitz Chair in Research Cardiology
Cedars-Sinai Heart Institute
Cedars-Sinai Medical Center
Anthony N. DeMaria, MD
Professor of Medicine
Judith and Jack White Chair in Cardiology
University of California, San Diego
Gary L. Schaer, MD
Professor of Medicine
Director, Cardiology Research and Strategic Development
Rush University Medical Center
David P. Recker, MD
Chief Medical Officer
Vericel Corporation
IxCELL-DCM Study Data Safety Monitoring Board (DSMB)
David D. Waters, MD – DSMB Chairman
Professor Emeritus Department of Medicine
University of California, San Francisco
Marc A. Pfeffer, MD, PhD
Cardiovascular Division, Brigham and Women’s Hospital and
Victor J. Dzau Professor of Medicine, Harvard Medical School
Nelson J. Chao, MD, MBA
Professor of Medicine and Immunology
Chief, Division of Hematological Malignancies and the Division of Cellular Therapy/Bone Marrow Transplant
Duke University
Cathie Leister, MS
Pharmaceutical Biostatistician
Independent Consultant
IxCELL-DCM Study Clinical Endpoint Adjudication
Brigham and Women’s Hospital Clinical Endpoint Center (CEC)
Akshay S. Desai, MD, MPH – CEC Committee Chairman
Associate Director Brigham Cardiovascular Consultants
Brigham and Women’s Hospital
Assistant Professor, Harvard Medical School
Peter V. Finn MD (physician reviewer) Cardiovascular Consultants
Brigham and Women’s Hospital
Assistant Professor, Harvard Medical School
L. Howard Hartley MD (physician reviewer) Cardiovascular Consultants
Brigham and Women’s Hospital
Assistant Professor, Harvard Medical School
IxCELL-DCM Study Statistics Core
Fang Dong – Clinical Programming Support – Vericel Corp
John Ilgenfritz – Independent Statistician
Jian Jing, PhD – Study Design & Biostatistics Center
University of Utah School Medicine
Mathew Brobeck - University of Utah School Medicine
Courtney Bartlett - University of Utah School Medicine
Amalia A. Winters - University of Utah School Medicine
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