1. ADAPTABLE The Aspirin Study Steering Committee
09 May 2017

2. Agenda for Today Enrollment Update Outreach Strategies Query 1
Lessons Learned
All Other Business

3. 29 sites active, 26 enrolling 5,571 Golden tickets entered
2,591 Randomized
31% of Projected enrollment
ClinicalTrials.gov: NCT

4. Monthly Enrollment (5/8)
2016
Site
Apr 2016
May 2016
Jun 2016
Jul 2016
Aug 2016
Sep 2016
Oct 2016
Nov 2016
Dec 2016
Total Enrolled 8 32 22 51 76 91
171
163
150
# of Sites Approaching 2 4 6 10 14 16
Total Approached
126
381
380
1,196
1,920
2,342
7,499
4,155
7,473
2017
Site
Jan 2017
Feb 2017
Mar 2017
Apr 2017
May 2017
Total Enrolled
296
360
450
599
122
# of Sites Approaching 17 22 23 26
Total Approached
5,645
12,432
14,532
18,231
4,364

5. Site Enrollment Average (5/8)
CDRN
Site
Site Activated
Started Enrollment
Total Enrolled
Enrollment Rate/Month
Mid-South
Duke
11/9/2016
November
287
47.8
Vanderbilt
4/18/2016
April
526
40.5
PaTH
UPMC
7/18/2016
August
298
33.1
OneFlorida
U of Florida
11/1/2016
166
27.7
GPC
Marshfield Clinic
February 71
23.7
NYC-CDRN
Montefiore
136
22.7
KUMC
121
20.2
CAPriCORN
U of Chicago
2/16/2017 58
19.3
Weill Cornell
3/8/2017
March 36
18.0
REACHnet
Ochsner
222
17.1
Penn State
9/23/2016
October
110
15.7
Iowa
123
13.7
Utah 94
13.4
MCW
January 53
13.3
pScanner
UCLA
11/7/2016 68
11.3
UNC
1/13/2017 9
9.0
UTSW 17
8.5
Northwestern
8/30/2016
September
7.3
Rush
9/19/2016 20
6.7
Mt Sinai
12/21/2016 12
6.0
NYU 32
5.3
Missouri 10
5.0
BSW 35
Nebraska 3
3.0
Temple 22
3.1
Tulane 4
0.6

6. Record Holders
Highest weekly enrollment of 191 patients (April 24-30, 2017)
Highest monthly enrollment of 599 patients (April 2017)
Site Records:
Weekly Enrollment
Vanderbilt – 50 patients (week of 4/24/17)
KUMC – 49 patients (week of 4/3/17)
University of Iowa – 37 patients (week of 2/13/17)
Monthly Enrollment
Vanderbilt – 97 patients (Oct 2016) & 96 (Apr 2017)
UPMC – 83 patients (Mar 2017)
Duke – 78 patients (Apr 2017)
KUMC – 67 patients (Apr 2017)

7. Retention Update (5/8) Retention
2,313 Week 1 Visits Expected: 1844 Complete (80%), 469 Total Late (20%), 154 >90 days Late (7%)
566 3mo Visits Expected: 383 Complete (68%), 183 Total Late (32%), 68 >90 Days (12%)
496 6 Month Visits Expected: 355 Completed (72%), 141 Total Late (28%), 32 >90 Days Late (6%)

8. Approach Strategies Enrollment End Date: March 1, 2018 Conversion Rate
Rapid Approach

9. ADAPTABLE Trial The Aspirin Study Paced Outreach David Crenshaw, Vanderbilt
Follow us on
ClinicalTrials.gov: NCT

10. Vanderbilt: Paced Outreach Approach
Expanded CP enables parallel clinic and approaches
Automated s scheduled for release in a staggered manner to facilitate phone call follow up
Both approaches help to “prime the pump” for the other.
Over 50% of patients with a clinic visit have an address on file
Aligning program to correspond date of release with upcoming cardiology clinic appointment

11. Automated Email Schedule
Monday
Tuesday
Wednesday
Week 1
Initial script 1 – Group 1
Week 2
Removal of declines, ineligible deceased for all groups
Initial script 1 – Group 2
Follow up script - Group 1
Phone follow up Group 1 initial
Week 3
Follow up script - Group 2
Phone follow up Group 2 Initial
Week 4
Final script – Group 1
Phone follow up Group 1 final
Week 5
Final script – Group 2
Initial - Group 3
Phone follow up Group 2 final

12. ADAPTABLE Trial The Aspirin Study Query 1
Follow us on
ClinicalTrials.gov: NCT

13. Query 1 Update Sent to Sites May 1, 2017 Responses due May 15, 2017
Endpoint Ascertainment
Impact of Data Latency
Alignment of PRO to CDM Events
Queries to be sent Quarterly after each DRN-OC Refresh

14. ADAPTABLE Trial The Aspirin Study Lessons Learned to Date
Follow us on
ClinicalTrials.gov: NCT

15. Other Items All Other Business? Next Call –
June 13th at 9:00am (Eastern Time)

16. Site Approach & Enrollment Update (5/8)
CDRN
Site
Total Number Eligible
Total Number Approached
% of Eligible Approached
Golden Tickets Entered
% Golden Tickets entered per Approached
Total Enrolled
# Non-internet Enrolled
% Enrolled Per Approached
% Enrolled Per Golden Ticket Entered
Enrolled last week
MidSouth
Vanderbilt
18,440
6,919
38%
978
14%
526 13 8%
54% 16
PaTH
UPMC
13,879
5,674
41%
914
16%
298 5%
33% 18
Mid-South
Duke
19,902
845 4%
401
47%
287 48
34%
72% 25
REACHnet
Ochsner
11,832
6,668
56%
600 9%
222 37 3%
37% 2
OneFlorida
U of Florida
29,738
12,978
44%
195 2%
166 31 1%
85% 4
NYC-CDRN
Montefiore
47,383
1,919
136 56 7%
82% 9
GPC
Iowa
14,512
5,328
268
123 6
46%
KUMC
12,936
3,916
30%
275
121
Penn St
2,708
2,647
98%
316
12%
110
35%
Utah
5,219
3,463
66%
213 6% 94 3
Marshfield Clinic
8,277
4,822
58%
137 71
52% 12
pScanner
UCLA
15,669
5,600
36%
141 68
48%
CAPriCORN
Northwestern
15,234
3,593
24%
124 58 1
U of Chicago
5,446
543
10% 60
11% 36
97%
MCW
5,731
2,741
157 53
Weill Cornell
17,253
853
120
BSW
2,081
1,858
89% 89 35 5
39%
NYU
49,254
1,126
140 32
23%
Temple
4,101
6,315
154% 97 22 0%
Rush
8,826
960 42 20
UTSW
2,459
495
20% 28 17
61%
Mt Sinai
41,876
279
13%
Missouri
1,004
617 10
UNC
5,204
347
32%
Tulane
771 63
Nebraska
3,475
102
Johns Hopkins
23,935
TOTAL
387,145
80,676
21%
5,571
2591
257
122

17. ADAPTABLE Enrollment Projections by CDRN (5/8)
16-Apr
16-May
16-Jun
16-Jul
16-Aug
16-Sep
16-Oct
16-Nov
16-Dec
17-Jan
17-Feb
17-Mar
17-Apr
17-May
PaTH
Projected 25 75
100
125
150
175
Actual 19 14 34 33
102 48
123 94 32 % 0%
76%
19%
33%
34%
82%
38%
63%
18%
GPC 8 1 16 31 10
117 54
141
32% 1%
21%
31% 8%
94%
36%
11%
pSCANNER 50 2 26 12 4 3%
35%
12%
10% 7%
NYCDRN 37 24 61 68 13
16%
37%
24%
41%
45% 9%
ReachNET 18 20 23 28 36 4%
64%
72%
40%
23%
28%
15%
17%
Mid-South 7 39 97 45 73
110
183 41
132%
56%
39%
97%
26%
49%
67%
73%
122%
CAPriCORN 5 3 42 46 5%
1 Florida 27
112%
124%
48%
13% 2%
Total
225
450
500
700
925
950
1150
1175
1325 22 51 76 91
171
163
296
360
599
122
44%
20%
51%
Cumulative
275
1450
2150
2850
3775
4725
5875
7050
8375 40 62
113
189
280
451
614
764
1060
1420
1870
2469
2591
29%
27%
30%