1. ADAPTABLE The Aspirin Study Steering Committee
11 April 2017

2. Agenda for Today Enrollment Update Health Care Plan Update Query 1
Working Group Update
Allocation of Non-Internet Participants
All Other Business

3. 28 sites active, 26 enrolling 4,376 Golden tickets entered
2,039 Randomized
29% of Projected enrollment
ClinicalTrials.gov: NCT

4. Site Enrollment Average (4/10)
CDRN
Site
Site Activated
Started Enrollment
Total Enrolled
Enrollment Rate/Month
Mid-South
Duke
11/9/2016
November
202
40.4
MidSouth
Vanderbilt
4/18/2016
April
427
35.6
OneFlorida
U of Florida
11/1/2016
138
27.6
PaTH
UPMC
7/18/2016
August
229
28.6
NYC-CDRN
Montefiore
107
21.4
GPC
KUMC
101
20.2
CAPriCORN
U of Chicago
2/16/2017
February 35
17.5
Weill Cornell
3/8/2017
March 17
17.0
REACHnet
Ochsner
16.8
Penn State
9/23/2016
October 96
16.0
Utah 84
14.0
Iowa
109
13.6
Marshfield Clinic 26
13.0
MCW
January 38
12.7
pScanner
UCLA
11/7/2016 61
12.2
UTSW 11
11.0
Missouri
12/21/2016 10
10.0
Mt Sinai 8
8.0
Northwestern
8/30/2016
September 52
7.4
BSW
9/19/2016 32
5.3
Rush
5.0
NYU 24
4.8
Temple 14
2.3
Nebraska 2
2.0
UNC
1/13/2017 1
1.0
Tulane 3
0.5

5. Record Holders
Highest weekly enrollment of 157 patients (April 3-9, 2017)
Highest monthly enrollment of 450 patients (March 2017)
Site Records:
Weekly Enrollment
KUMC – 48 patients (week of 4/3/17)
University of Iowa – 37 patients (week of 2/13/17)
UPMC – 30 patients (weeks of 3/13/17 & 3/27/17)
Monthly Enrollment
Vanderbilt – 97 patients (October 2016)
UPMC – 83 patients (March 2017)
Duke – 74 patients (March 2017)

6. Site Approach & Enrollment Update (4/10)
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
6,134
33%
819
13%
427 10 7%
52% 11
PaTH
UPMC
13,879
5,220
38%
691
229 4% 13
REACHnet
Ochsner
11,832
5,567
47%
520 9%
202 32
39% 9
Mid-South
Duke
19,902
703
289
41% 26
29%
70% 17
OneFlorida
U of Florida
29,738
4,414
15%
149 3%
138 23
93% 3
GPC
Iowa
14,512
5,274
36%
224
109 6 2%
49%
NYC-CDRN
Montefiore
47,383
1,605
127 8%
107 40
84%
KUMC
12,936
1,621
242
101 6%
42% 48
Penn St
2,708
2,647
98%
272
10% 96
35%
Utah
5,219
3,417
65%
192 84 8
44% 5
pScanner
UCLA
15,669
5,600
132 61 1 1%
46%
CAPriCORN
Northwestern
15,234
3,593
24%
108 52
48% 4
MCW
5,731
2,741 98 38
U of Chicago
5,446
543 36 35 24
97%
BSW
2,081
1,700
82% 80 5%
40%
Marshfield Clinic
8,277
1,927
23% 54 2
NYU
49,254
865
22%
Weill Cornell
17,253
639 73
11% 7
Temple
4,101
1,162
28% 44 14
32%
UTSW
2,459
254 19
58%
Rush
8,826
840
43%
Missouri
1,004
437
Mt Sinai
41,876
185 0% 29
16%
Tulane
771 62
60%
Nebraska
3,200
102
UNC
5,204
145
Johns Hopkins
23,935
20%
TOTAL
362,935
57,402
4,376
2039
183
157

7. Retention Update (4/10) Retention
1781 Week 1 Visits Expected: 1438 Complete (81%), 343 Total Late (19%), 117 >90 days Late (7%)
418 3mo Visits Expected: 285 Complete (68%), 133 Total Late (32%), 43 >90 Days (10%)
312 6 Month Visits Expected: 229 Completed (73%), 83 Total Late (27%), 23 >90 Days Late (7%)

8. HealthCore Overview Research subsidiary of Anthem
Clients include life science companies, health plans, government agencies, and academic research centers
Founding collaborator with the FDA Sentinel System
Conduct over 60 queries a year within the Sentinel CDM
Over 140 highly specialized, multi-disciplinary professionals
primarily research scientists and data analysts dedicated to health services and outcomes research
COMPANY CONFIDENTIAL | DO NOT COPY

9. HealthCore/Anthem Research Network (HCARN)
A PCORnet Health Plan Research Network (HPRN)
Funded to support PCORnet and the Demonstration Projects
Additional methodology study to collaborate with PPRNs
HealthCore has been a leader in utilization of the Common Data Model as a founding collaborative member of the FDA Sentinel System
HealthCore executes over 60 routine safety queries a year

10. HIRD - Researchable Population Density by State
7/15/2019
HIRD - Researchable Population Density by State
Medical and Pharmacy WA ME MT ND MI VT MN
New Hampshire OR NY WI MA ID SD MI
Rhode Island WY PA
Connecticut IA NJ NE OH
Delaware IN NV IL UT WV CO VA
Washington, DC CA KS MO KY NC
Virginia TN OK SC AZ AR NM
Anthem states*
>1,000,000
500,000 – 1,000,000
250,000 – 500,000
100,000 – 250,000
<100,000 AL GA MS TX LA FL
*California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia, Wisconsin
COMPANY CONFIDENTIAL | DO NOT COPY
Enter Filename Here

11. Pre & Post Query Run Checklist:
Query 1- May 1, 2017
Pre & Post Query Run Checklist:
Before responding to data characterization refresh 2 (due April 24)
Update the PCORNET_TRIAL table to include as many patients as possible
Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated.
Check that the length of PATID in all tables including PCORNET_TRIAL table matches by running the PCORNET_TRIAL Diagnostic Query.
Check that the trial participants are present in the expected tables by running the PCORNET_TRIAL Diagnostic Query
Check the completeness of the discharge disposition data for inpatient encounters
Check the completeness of the principal diagnosis data for inpatient encounters.
Ensure that ICD procedure codes after Oct 2015 are included and classified as ICD10*
Ensure that ICD diagnoses codes after Oct 2015 are included and classified as ICD10*
Before running ADAPTABLE Query 1
Update the PCORNET_TRIAL table to include all patients who enrolled on or before April 15, 2017
Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated. NOTE: This date should be after April 15, 2017 – see ‘Reminders about populating the PCORENT_TRIAL table’ below.
Ensure that PATID, TRIAL_ENROLL_DATE, TRIAL_END_DATE, and TRIAL_WITHDRAW_DATE variables are internally consistent across other CDM tables for the same patient
Ensure that only data from participating ADAPTABLE DataMarts are queried
After running ADAPTABLE Query 1 (due May 15)
Review output to confirm that the layout and contents conform to the layouts in this work plan and the results you would expect. Section VII Table Shells should be used as a reference.
*Partners who had potential problems with code type assignments received a communication from the PCORnet Coordinating Center. Tools to identify these errors are located here:

12. Working Group Progress
IRB Challenges - Address IRB challenges for pragmatic studies including approval of broad/novel patient approach methods, patient partner involvement, and use of social media channels to raise awareness
Recruitment Optimization - Address challenges with implementing the Computable phenotype, best practice for organizing local tracking of eligible participants, and optimizing multi-touch approach
Patient Engagement - Address patient engagement and outreach through channels such as social media and optimizing the role of the Adaptors as part of local CDRN team
Patient Retention - Address perceived challenges with retention, delineate the role of local clinical team in supporting retention, and optimize communications and content to engage participants throughout the duration of the study

13. Allocation of Non-Internet Participants
Cap of 1,000 non-internet participants total
Allocation of 125 per each CDRN
Reallocation Discussion

14. Other Items All Other Business? Next Call –
May 9th at 9:00am (Eastern Time)