Clinical trial NCT03543358
Conditions: Cancer
Keywords: rovalpituzumab tesirine rollover study cancer
Sponsor: AbbVie
Start date: 2018-09-10; Completion date: 2019-11-26
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

Detailed description:

Arms: arm 1: Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period. arm 2: Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.
Interventions: intervention 1: rovalpituzumab tesirine intervention 2: rovalpituzumab tesirine
Intervention descriptions: intervention 1: Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles intervention 2: Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.

Protocol documents:
Prot_SAP_000.pdf: 
NCT03543358


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TABLE OF CONTENTS
1
SYNOPSIS
5
2
INTRODUCTION
8
2.1
BACKGROUND AND RATIONALE
8
2.2
BENEFITS AND RISKS TO SUBJECTS
8
3
STUDY OBJECTIVES AND ENDPOINTS
8
3.1
OBJECTIVES
8
3.2
EFFICACY EVALUATIONS
9
3.3
SAFETY EVALUATIONS
9
3.4
PHARMACOKINETIC EVALUATIONS
10
3.5
IN VIVO BIOMARKER AND EXPLORATORY RESEARCH
10
4
INVESTIGATIONAL PLAN
10
4.1
OVERALL STUDY DESIGN AND PLAN
10
4.2
DISCUSSION OF STUDY DESIGN
11
5
STUDY ACTIVITIES
12
5.1
ELIGIBILITY CRITERIA
12
5.2
CONTRACEPTION RECOMMENDATIONS
14
5.3
PROHIBITED MEDICATIONS AND THERAPY
15
5.4
PRIOR AND CONCOMITANT THERAPY
15
5.5
WITHDRAWAL OF SUBJECTS AND DISCONTINUATION OF STUDY
15
5.6
FOLLOW-UP FOR SUBJECT WITHDRAWAL FROM STUDY
16
5.7
STUDY DRUG
16
5.8
RANDOMIZATION/DRUG ASSIGNMENT
17
5.9
PROTOCOL DEVIATIONS
17
6
SAFETY CONSIDERATIONS
17
6.1
COMPLAINTS AND ADVERSE EVENTS
17
6.2
TOXICITY MANAGEMENT
20
6.3
TEAE CASE DEFINITION/GUIDANCE
21
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6.4
PRODUCT COMPLAINTS
23
7
STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
23
7.1
STATISTICAL AND ANALYTICAL PLANS
23
7.2
DEFINITION FOR ANALYSIS POPULATIONS
23
7.3
DISPOSITION OF STUDY SUBJECTS
23
7.4
STATISTICAL ANALYSES FOR EFFICACY
24
7.5
STATISTICAL ANALYSES FOR SAFETY
24
7.6
DETERMINATION OF SAMPLE SIZE
25
8
ETHICS
25
8.1
INDEPENDENT ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD (IEC/IRB)
25
8.2
ETHICAL CONDUCT OF THE STUDY
25
8.3
SUBJECT CONFIDENTIALITY
25
9
SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
25
10 DATA QUALITY ASSURANCE
26
11 COMPLETION OF THE STUDY
26
12 REFERENCES
26
LIST OF FIGURES
FIGURE 1.
STUDY SCHEMATIC
11
LIST OF APPENDICES
APPENDIX A.
STUDY SPECIFIC ABBREVIATIONS AND TERMS
27
APPENDIX B.
RESPONSIBILITIES OF THE INVESTIGATOR
29
APPENDIX C.
LIST OF PROTOCOL SIGNATORIES
30
APPENDIX D.
ACTIVITY SCHEDULE
31
APPENDIX E.
PROTOCOL SUMMARY OF CHANGES
36
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX F.
OPERATIONS MANUAL
37
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Ϯ͘Ϯ ĞŶĞĨŝƚƐĂŶĚZŝƐŬƐƚŽ^ƵďũĞĐƚƐ
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Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or 
Metastatic DLL3high SCLC who have First Disease Progression During or Following Front-Line Platinum-
Based Chemotherapy" ŚĂĚƐŚŽƌƚĞƌƐƵƌǀŝǀĂůŝŶƚŚĞZŽǀĂͲdĂƌŵĐŽŵƉĂƌĞĚǁŝƚŚƚŚĞƚŽƉŽƚĞĐĂŶĐŽŶƚƌŽůĂƌŵ͘
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dĞƐŝƌŝŶĞ/ŶǀĞƐƚŝŐĂƚŽƌƌŽĐŚƵƌĞ͘ϭ
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ϯ͘ϭ KďũĞĐƚŝǀĞƐ
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WĂŐĞϴŽĨϳϬ


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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϯ͘Ϯ ĨĨŝĐĂĐǇǀĂůƵĂƚŝŽŶƐ
dŚĞƌĞĂƌĞŶŽĞĨĨŝĐĂĐǇ ŽďũĞĐƚŝǀĞƐĂŶĚĞŶĚƉŽŝŶƚƐĨŽƌƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͘>ŝŵŝƚĞĚĞĨĨŝĐĂĐǇĚĂƚĂǁŝůůďĞ
ĐŽůůĞĐƚĞĚĂŶĚůŝƐƚĞĚ͘ŐŐƌĞŐĂƚĞƐƵŵŵĂƌŝĞƐĂŶĚŽƚŚĞƌƐƚĂƚŝƐƚŝĐĂůĂŶĂůǇƐĞƐŽĨĞĨĨŝĐĂĐǇĚĂƚĂĂƌĞŶŽƚ
ƉůĂŶŶĞĚ͘ĨĨŝĐĂĐǇĚĂƚĂŝŶĐůƵĚŝŶŐƌĂĚŝŽŐƌĂƉŚŝĐĚŝƐĞĂƐĞƌĞƐƉŽŶƐĞĂƐƐĞƐƐŵĞŶƚ ďǇZĞƐƉŽŶƐĞǀĂůƵĂƚŝŽŶ
ƌŝƚĞƌŝĂŝŶ^ŽůŝĚdƵŵŽƌƐ;Z/^dͿǀĞƌƐŝŽŶϭ͘ϭϮ ĂŶĚƐƵƌǀŝǀĂůĨŽƌĞĂĐŚƐƵďũĞĐƚǁŝůůďĞĐŽůůĞĐƚĞĚĂŶĚŽŶůǇƌĂǁ
ĚĂƚĂͬůŝƐƚŝŶŐƐǁŝůůďĞŐĞŶĞƌĂƚĞĚ͘
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ϯ͘ϯ ^ĂĨĞƚǇǀĂůƵĂƚŝŽŶƐ
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ƚƌĞĂƚŵĞŶƚͬƌĞƚƌĞĂƚŵĞŶƚŝŶƚŚŝƐƐƚƵĚǇ͕ĂůůƐƌĞŐĂƌĚůĞƐƐŽĨƐĞƌŝŽƵƐŶĞƐƐŽƌĐĂƵƐĂůŝƚǇ͕ǁŝůůďĞƌĞƉŽƌƚĞĚ
ƚŚƌŽƵŐŚϳϬĚĂǇƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƚƌĞĂƚŵĞŶƚ͘KŶůǇƚƌĞĂƚŵĞŶƚͲƌĞůĂƚĞĚƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚƐ;^ƐͿ
ǁŝůůďĞĐŽůůĞĐƚĞĚƉŽƐƚϳϬĚĂǇƐŽĨƚŚĞůĂƐƚĚŽƐĞŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƌĞĐĞŝǀĞĚŝŶƚŚĞƐƚƵĚǇ͘/ŶƚŚŽƐĞ
ƐƵďũĞĐƚƐŝŶƌŵǁŚŽĂƌĞŶŽƚƌĞĐĞŝǀŝŶŐƚƌĞĂƚŵĞŶƚ͕ŽŶůǇƚƌĞĂƚŵĞŶƚͲƌĞůĂƚĞĚ^ƐǁŝůůďĞĐŽůůĞĐƚĞĚ͘dŚĞ
ƌĞƉŽƌƚŝŶŐǁŝŶĚŽǁƐĂƌĞĚĞƐĐƌŝďĞĚďĞůŽǁŝŶƚŚĞƐĐŚĞŵĂ͘
>ĂƐƚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĚŽƐĞƌĞĨĞƌƐƚŽƚŚĞůĂƐƚĚŽƐĞƌĞĐĞŝǀĞĚďǇƚŚĞƐƵďũĞĐƚŝŶĞŝƚŚĞƌƚŚĞƉĂƌĞŶƚƐƚƵĚǇ;ƌŵ͕EŽ
ZĞƚƌĞĂƚŵĞŶƚͿŽƌƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ;ƌŵZĞƚƌĞĂƚŵĞŶƚŽƌƌŵͿ͘
&ƵƌƚŚĞƌĚĞƚĂŝůƐŽŶƌĞƉŽƌƚŝŶŐĂƌĞƉƌŽǀŝĚĞĚŝŶ^ĞĐƚŝŽŶϲ͘ϭ ĂŶĚƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘&Žƌ
ƐƚĂƚŝƐƚŝĐĂůĂŶĂůǇƐŝƐƉƌŽǀŝĚĞĚĨŽƌƐƚƵĚǇĚŝƐĐůŽƐƵƌĞ͕ƌĞĨĞƌƚŽ^ĞĐƚŝŽŶϳ͘ϱ͘
WĂŐĞϵŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϯ͘ϰ WŚĂƌŵĂĐŽŬŝŶĞƚŝĐǀĂůƵĂƚŝŽŶƐ
ŽůůĞĐƚŝŽŶŽĨƐĂŵƉůĞƐĨŽƌƉŚĂƌŵĂĐŽŬŝŶĞƚŝĐƐĂŶĚĂŶƚŝͲƚŚĞƌĂƉĞƵƚŝĐĂŶƚŝďŽĚŝĞƐŝƐŶŽƚŝŶĐůƵĚĞĚŝŶƚŚŝƐ
ĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͘
ϯ͘ϱ /ŶsŝǀŽŝŽŵĂƌŬĞƌĂŶĚǆƉůŽƌĂƚŽƌǇZĞƐĞĂƌĐŚ
EŽƚĂƉƉůŝĐĂďůĞ͘
ϰ /Es^d/'d/KE>W>E
ϰ͘ϭ KǀĞƌĂůů^ƚƵĚǇĞƐŝŐŶĂŶĚWůĂŶ
dŚŝƐŝƐĂƉŚĂƐĞϮ͕ŵƵůƚŝĐĞŶƚĞƌ͕ůŽŶŐͲƚĞƌŵ͕ƌŽůůŽǀĞƌĨŽůůŽǁͲƵƉĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͘/ƚǁŝůůďĞĐŽŶĚƵĐƚĞĚŝŶ
ΕϮϬ ƐŝƚĞƐŝŶƚŚĞƐĂŵĞĐŽƵŶƚƌŝĞƐĂƐƚŚĞƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƉĂƌĞŶƚƐƚƵĚŝĞƐ͖ƉŽƚĞŶƚŝĂůůǇŝŶĐůƵĚŝŶŐ͕ďƵƚ
ŶŽƚůŝŵŝƚĞĚƚŽ͕ĂŶĂĚĂ͕&ƌĂŶĐĞ͕>ĂƚǀŝĂ͕^ƉĂŝŶ͕ƚŚĞhŶŝƚĞĚ<ŝŶŐĚŽŵ͕ĂŶĚƚŚĞhŶŝƚĞĚ^ƚĂƚĞƐ͘DŽƌĞƐƚƵĚǇ
ƐŝƚĞƐĂŶĚĐŽƵŶƚƌŝĞƐŵĂǇďĞŝŶĐůƵĚĞĚĂƐŽƚŚĞƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƉĂƌĞŶƚƐƚƵĚŝĞƐĐŽŵƉůĞƚĞƚŚĞŝƌ
ƉƌŝŵĂƌǇĂŶĂůǇƐĞƐĂŶĚĐůŽƐĞ͘
dŚĞƐĐŚĞĚƵůĞŽĨĂƐƐĞƐƐŵĞŶƚƐǁŝůůĚĞƉĞŶĚŽŶǁŚĞƚŚĞƌƐƵďũĞĐƚƐĞŶƚĞƌƚŚĞƐƚƵĚǇŝŶƉŽƐƚͲƚƌĞĂƚŵĞŶƚ
ĨŽůůŽǁͲƵƉŽƌƌĞĐĞŝǀŝŶŐŽŶŐŽŝŶŐƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƚƌĞĂƚŵĞŶƚĨƌŽŵƚŚĞƉĂƌĞŶƚƐƚƵĚǇ͘
dŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇŝŶĐůƵĚĞƐϮ^ƚƵĚǇƌŵƐ͗
•
ƌŵ͗^ƵďũĞĐƚƐǁŚŽĞŶƚĞƌƚŚĞĞǆƚĞŶƐŝŽŶƐƚƵĚǇǁŚŝůĞŝŶƉŽƐƚͲƚƌĞĂƚŵĞŶƚĨŽůůŽǁͲƵƉ͘dŚŝƐĂƌŵ
ŝŶĐůƵĚĞƐŽƉƚŝŽŶĂůƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƌĞƚƌĞĂƚŵĞŶƚĨŽƌƚŚŽƐĞǁŚŽƋƵĂůŝĨǇ͘DŽƐƚƐƵďũĞĐƚƐ
ĨƌŽŵĂůůƐƚƵĚŝĞƐǁŝůůďĞŝŶƚŚŝƐĂƌŵ͘dŚĞƐĞƉĂƌĞŶƚƐƚƵĚŝĞƐŝŶĐůƵĚĞ͕ďƵƚ ĂƌĞŶŽƚůŝŵŝƚĞĚƚŽ͕
^ƚƵĚǇ ^ZyϬϬϭͲϬϬϮ͕^ƚƵĚǇ^ZyϬϬϭͲϬϬϰ͕^ƚƵĚǇ^ZyϬϬϭͲϬϬϲ͕^ƚƵĚǇ^ZyϬϬϭͲϬϬϳ͕ĂŶĚ
^ƚƵĚǇ DϭϲͲϮϴϵ͘
•
ƌŵ͗^ƵďũĞĐƚƐǁŚŽĞŶƚĞƌƚŚĞĞǆƚĞŶƐŝŽŶƐƚƵĚǇǁŚŝůĞƌĞĐĞŝǀŝŶŐŽŶŐŽŝŶŐƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ
ƚƌĞĂƚŵĞŶƚŝŶƚŚĞƉĂƌĞŶƚƐƚƵĚǇ;Ğ͘Ő͕͘^ƚƵĚǇ^ZyϬϬϭͲϬϬϳͿ͘
^ƚƵĚǇƐƉĞĐŝĨŝĐƐĨŽƌƌŵƐĂŶĚĂƌĞƉƌĞƐĞŶƚĞĚŝŶ&ŝŐƵƌĞ ϭ͘
WĂŐĞϭϬŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Figure 1.
Study Schematic
ͬс^ƚƵĚǇĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶ͖dǆсdƌĞĂƚŵĞŶƚ
ϰ͘Ϯ ŝƐĐƵƐƐŝŽŶŽĨ^ƚƵĚǇĞƐŝŐŶ
ŚŽŝĐĞŽĨŽŶƚƌŽů'ƌŽƵƉ
dŚĞƌĞŝƐŶŽĐŽŶƚƌŽůŐƌŽƵƉŝŶƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͘
ƉƉƌŽƉƌŝĂƚĞŶĞƐƐŽĨDĞĂƐƵƌĞŵĞŶƚƐ
^ƚĂŶĚĂƌĚĐůŝŶŝĐĂůĂŶĚůĂďŽƌĂƚŽƌǇƉƌŽĐĞĚƵƌĞƐǁŝůůďĞƵƚŝůŝǌĞĚŝŶƚŚŝƐƐƚƵĚǇ͘ůůĞĨĨŝĐĂĐǇ ŵĞĂƐƵƌĞŵĞŶƚƐŝŶ
ƚŚŝƐƐƚƵĚǇĂƌĞƐƚĂŶĚĂƌĚĨŽƌĂƐƐĞƐƐŝŶŐĚŝƐĞĂƐĞĂĐƚŝǀŝƚǇŝŶƐƵďũĞĐƚƐǁŝƚŚ^>ĂŶĚŽƚŚĞƌŝŶĚŝĐĂƚŝŽŶƐĨƌŽŵ
ƉĂƌĞŶƚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƐƚƵĚŝĞƐ;Ğ͘Ő͕͘^ƚƵĚǇ^ZyϬϬϭͲϬϬϲͿ͘
^ƵŝƚĂďŝůŝƚǇŽĨ^ƵďũĞĐƚWŽƉƵůĂƚŝŽŶ
dŚĞƐĞĂƌĞĂůůƐƵďũĞĐƚƐǁŚŽǁĞƌĞĞŶƌŽůůĞĚŝŶƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƚƌĞĂƚŵĞŶƚƐƚƵĚŝĞƐ͕ďƵƚŚĂǀĞŶŽƚǇĞƚ
ƌĞĂĐŚĞĚϭŽƌŵŽƌĞĞŶĚƉŽŝŶƚƐŝŶƚŚĞƉĂƌĞŶƚƐƚƵĚǇĂƚƚŚĞƚŝŵĞŽĨƉƌŝŵĂƌǇĂŶĂůǇƐĞƐ͘/ŶĂĚĚŝƚŝŽŶ͕ƐƵďũĞĐƚƐ
ǁŚŽǁĞƌĞĞůŝŐŝďůĞĨŽƌƌĞƚƌĞĂƚŵĞŶƚďĂƐĞĚŽŶƚŚĞĐƌŝƚĞƌŝĂǁƌŝƚƚĞŶŝŶƚŚĞƉĂƌĞŶƚƐƚƵĚǇ ǁŝůůŚĂǀĞƚŚĂƚ
ŽƉƉŽƌƚƵŶŝƚǇŝŶƚŚŝƐƐƚƵĚǇ͘
WĂŐĞϭϭŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ůůƐƵďũĞĐƚƐŵƵƐƚŚĂǀĞƌĞĐĞŝǀĞĚĂƚůĞĂƐƚϭĚŽƐĞŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝŶƚŚĞƉĂƌĞŶƚƐƚƵĚǇ͘/ŶŽƌĚĞƌ
ƚŽƌĞĐĞŝǀĞŽƉƚŝŽŶĂůƌĞƚƌĞĂƚŵĞŶƚŝŶƌŵ͕ƐƵďũĞĐƚƐŵƵƐƚŵĞĞƚƚŚĞďĞůŽǁĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝĂŝŶ^ĞĐƚŝŽŶϱ͘ϭ͘
^ĞůĞĐƚŝŽŶŽĨŽƐĞƐŝŶƚŚĞ^ƚƵĚǇ
^ƵďũĞĐƚƐǁŚŽƌĞĐĞŝǀĞƚƌĞĂƚŵĞŶƚŝŶƚŚŝƐƐƚƵĚǇǁŝůůƌĞĐĞŝǀĞƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĂƚĂĚŽƐĞŽĨϬ͘ϯ ŵŐͬŬŐ
ŽŶĂǇϭŽĨĞǀĞƌǇϲǁĞĞŬƚƌĞĂƚŵĞŶƚĐǇĐůĞ͘/ĨĂƐƵďũĞĐƚƉƌĞǀŝŽƵƐůǇƌĞƋƵŝƌĞĚĂĚŽƐĞƌĞĚƵĐƚŝŽŶĚƵƌŝŶŐƚŚĞ
ƉĂƌĞŶƚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƐƚƵĚǇ͕ƚŚĞŶƚŚĂƚƌĞĚƵĐĞĚĚŽƐĞǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚĨŽƌƚŚŽƐĞǁŝƚŚ
ŽŶŐŽŝŶŐƚƌĞĂƚŵĞŶƚŽƌƚŚŽƐĞĞůĞĐƚŝŶŐƌĞƚƌĞĂƚŵĞŶƚ͘ŽƐĞƌĞĚƵĐƚŝŽŶƐŵĂǇĂůƐŽŽĐĐƵƌĚƵƌŝŶŐƚƌĞĂƚŵĞŶƚŽƌ
ƌĞƚƌĞĂƚŵĞŶƚ͘/ĨĂƐƵďũĞĐƚƌĞƋƵŝƌĞƐĂĚŽƐĞƌĞĚƵĐƚŝŽŶ͕ĞŝƚŚĞƌŝŶƚŚĞƉĂƌĞŶƚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƐƚƵĚǇ
ŽƌƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͕ĚŽƐĞƌĞͲĞƐĐĂůĂƚŝŽŶŝƐŶŽƚĂůůŽǁĞĚ͘
ϱ ^dhzd/s/d/^
ϱ͘ϭ ůŝŐŝďŝůŝƚǇƌŝƚĞƌŝĂ
^ƚƵĚǇŶƚƌǇƌŝƚĞƌŝĂ
&ŽƌďŽƚŚƌŵƐĂŶĚ͖ƚŚĞĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝĂĂƌĞƚŚĂƚĂƐƵďũĞĐƚŚĂƐĞŶƌŽůůĞĚ͕ƉĂƌƚŝĐŝƉĂƚĞĚŝŶ͕ĂŶĚ
ƌĞĐĞŝǀĞĚĂƚůĞĂƐƚϭĚŽƐĞŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝŶĂƉĂƌĞŶƚƐƚƵĚǇ͘
ƌŵKƉƚŝŽŶĂůZĞƚƌĞĂƚŵĞŶƚƌŝƚĞƌŝĂ
ĚĚŝƚŝŽŶĂůĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝŽŶĨŽƌƌŵ ŝƐƚŚĂƚƐƵďũĞĐƚƐǁŚŽĚŝƐĐŽŶƚŝŶƵĞĚƚŚĞƐƚƵĚǇĚƌƵŐŝŶƚŚĞƉĂƌĞŶƚ
ƐƚƵĚǇŚĂǀĞĐŽŵƉůĞƚĞĚƚŚĞƚƌĞĂƚŵĞŶƚĞŵĞƌŐĞŶƚƌĞƉŽƌƚŝŶŐǁŝŶĚŽǁ;Ğ͘Ő͕͘ϯϬĚĂǇƐƉŽƐƚůĂƐƚĚŽƐĞĨŽƌ
^ƚƵĚǇ ^ZyϬϬϭͲϬϬϮͿ͘
^ƵďũĞĐƚƐǁŚŽĞůĞĐƚŽƉƚŝŽŶĂůƌĞƚƌĞĂƚŵĞŶƚŝŶƌŵŵƵƐƚŵĞĞƚĂůůŽĨƚŚĞĨŽůůŽǁŝŶŐĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝĂďĞĨŽƌĞ
ƌĞĐĞŝǀŝŶŐƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƌĞƚƌĞĂƚŵĞŶƚ͘WƌŝŽƌƚŽƉƌŽǀŝĚŝŶŐƌĞƚƌĞĂƚŵĞŶƚƚŽƐƵďũĞĐƚƐ͕ƐƚƵĚǇ
ŝŶǀĞƐƚŝŐĂƚŽƌƐƐŚŽƵůĚĐŽŶƐƵůƚǁŝƚŚƚŚĞďďsŝĞDĞĚŝĐĂůDŽŶŝƚŽƌ͘
ĞŵŽŐƌĂƉŚŝĐĂŶĚ>ĂďŽƌĂƚŽƌǇƐƐĞƐƐŵĞŶƚƐ
ϭ͘ dŽůĞƌĂƚĞĚƚŚĞŝƌŝŶŝƚŝĂůϮĚŽƐĞƐŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ
Ϯ͘ ĐŚŝĞǀĞĚĐůŝŶŝĐĂůďĞŶĞĨŝƚĨƌŽŵƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͕ĚĞĨŝŶĞĚĂƐƐƚĂďůĞĚŝƐĞĂƐĞŽƌďĞƚƚĞƌ͕
ĂŶĚŝƐĚĞƚĞƌŵŝŶĞĚƚŚĂƚƚŚĞƐƵďũĞĐƚǁŽƵůĚƉŽƚĞŶƚŝĂůůǇďĞŶĞĨŝƚĨƌŽŵĂĚĚŝƚŝŽŶĂůƚƌĞĂƚŵĞŶƚ
KZ
ĐŚŝĞǀĞĚĐůŝŶŝĐĂůďĞŶĞĨŝƚĂƐĚĞĨŝŶĞĚďǇƐƚĂďůĞĚŝƐĞĂƐĞŽƌďĞƚƚĞƌĂŶĚĞǆƉĞƌŝĞŶĐĞĚƌĂĚŝŽŐƌĂƉŚŝĐ
ĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶ ĂƚůĞĂƐƚϭϮǁĞĞŬƐĂĨƚĞƌůĂƐƚĚŽƐĞ ŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƉĞƌZ/^dϭ͘ϭ
ϯ͘ ZĞĐĞŝǀĞĚŶŽŽƚŚĞƌƐǇƐƚĞŵŝĐĂŶƚŝͲĐĂŶĐĞƌƚŚĞƌĂƉǇĂĨƚĞƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƚƌĞĂƚŵĞŶƚ
ϰ͘ ĂƐƚĞƌŶŽŽƉĞƌĂƚŝǀĞKŶĐŽůŽŐǇ'ƌŽƵƉ;K'ͿƉĞƌĨŽƌŵĂŶĐĞƐƚĂƚƵƐŽĨϬŽƌϭ͘^ĞĞƚŚĞ
KƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕ƉƉĞŶĚŝǆĨŽƌĐŽŶǀĞƌƐŝŽŶŽĨƉĞƌĨŽƌŵĂŶĐĞƐƚĂƚƵƐƵƐŝŶŐ<ĂƌŶŽĨƐŬǇƐĐĂůĞƐ͕ŝĨ
ĂƉƉůŝĐĂďůĞ
ϱ͘ DŝŶŝŵƵŵůŝĨĞĞǆƉĞĐƚĂŶĐǇŽĨĂƚůĞĂƐƚϭϮǁĞĞŬƐ
WĂŐĞϭϮŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϲ͘ Laboratory values ŵĞĞƚŝŶŐƚŚĞĨŽůůŽǁŝŶŐĐƌŝƚĞƌŝĂǁŝƚŚŝŶƚŚĞƐĐƌĞĞŶŝŶŐƉĞƌŝŽĚƉƌŝŽƌƚŽƚŚĞ
ĨŝƌƐƚ ĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͗
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ďƐŽůƵƚĞŶĞƵƚƌŽƉŚŝůĐŽƵŶƚ;EͿшϭ͕ϱϬϬͬʅ>͖
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WůĂƚĞůĞƚĐŽƵŶƚшϳϱ͕ϬϬϬͬʅ>͖
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^ĞƌƵŵƚŽƚĂůďŝůŝƌƵďŝŶчϭ͘ϱпƵƉƉĞƌůŝŵŝƚŽĨŶŽƌŵĂů;h>EͿŽƌчϯпh>EĨŽƌƐƵďũĞĐƚƐǁŝƚŚ
'ŝůďĞƌƚΖƐĚŝƐĞĂƐĞ͖
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^ĞƌƵŵĂůĂŶŝŶĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ;>dͿĂŶĚĂƐƉĂƌƚĂƚĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ;^dͿчϮ͘ϱпh>E
;ч ϱпh>EŝĨĞǀŝĚĞŶĐĞŽĨŚĞƉĂƚŝĐŝŶǀŽůǀĞŵĞŶƚďǇŵĂůŝŐŶĂŶƚĚŝƐĞĂƐĞͿ͖
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^ĞƌƵŵĐƌĞĂƚŝŶŝŶĞчϭ͘ϱпh>EŽƌĞƐƚŝŵĂƚĞĚŐůŽŵĞƌƵůĂƌĨŝůƚƌĂƚŝŽŶƌĂƚĞ;Ğ'&ZͿ
ш ϯϬ ŵ>ͬŵŝŶͬϭ͘ϳϯŵϮ ĂƐĐĂůĐƵůĂƚĞĚďǇƚŚĞϰͲǀĂƌŝĂďůĞDŽĚŝĨŝĐĂƚŝŽŶŽĨŝĞƚŝŶZĞŶĂůŝƐĞĂƐĞ
ƐƚƵĚǇĞƋƵĂƚŝŽŶ;'&Z;ŵ>ͬŵŝŶͬϭ͘ϳϯŵϮͿсϭϳϱп;ƐĞƌƵŵĐƌĞĂƚŝŶŝŶĞ΀ŵŐͬĚ>΁Ϳʹϭ͘ϭϱϰп;ĂŐĞ
΀ǇĞĂƌƐ΁ͿʹϬ͘ϮϬϯпϬ͘ϳϰϮ;ŝĨĨĞŵĂůĞͿпϭ͘ϮϭϮ;ŝĨĨƌŝĐĂŶŵĞƌŝĐĂŶͿ͘ϯ
ŝƐĞĂƐĞĐƚŝǀŝƚǇ
ϳ͘ ZĞĐŽǀĞƌǇƚŽ'ƌĂĚĞϭ ŽƌďĂƐĞůŝŶĞ ŽĨĂŶǇĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƌĞůĂƚĞĚ
ƚŽǆŝĐŝƚǇ;ĞǆĐůƵĚŝŶŐĂůŽƉĞĐŝĂͿƉƌŝŽƌƚŽŝŶŝƚŝĂƚŝŽŶŽĨƐƚƵĚǇĚƌƵŐ
ϴ͘ /ŶƐƵďũĞĐƚƐǁŝƚŚĐĞŶƚƌĂůŶĞƌǀŽƵƐƐǇƐƚĞŵ;E^ͿŵĞƚĂƐƚĂƐĞƐ͕ĚŽĐƵŵĞŶƚĂƚŝŽŶŽĨƐƚĂďůĞŽƌ
ŝŵƉƌŽǀĞĚƐƚĂƚƵƐďĂƐĞĚŽŶďƌĂŝŶŝŵĂŐŝŶŐĨŽƌĂƚůĞĂƐƚϮǁĞĞŬƐĂĨƚĞƌĐŽŵƉůĞƚŝŽŶŽĨĚĞĨŝŶŝƚŝǀĞ
ƚƌĞĂƚŵĞŶƚĂŶĚǁŝƚŚŝŶϮǁĞĞŬƐƉƌŝŽƌƚŽŝŶŝƚŝĂƚŝŽŶŽĨƌĞƚƌĞĂƚŵĞŶƚ͕ŽĨĨŽƌŽŶĂƐƚĂďůĞĚŽƐĞŽĨ
ĐŽƌƚŝĐŽƐƚĞƌŽŝĚƐ͘;EŽƚĞ͗ĞĨŝŶŝƚŝǀĞƚƌĞĂƚŵĞŶƚŵĂǇŝŶĐůƵĚĞƐƵƌŐŝĐĂůƌĞƐĞĐƚŝŽŶ͕ǁŚŽůĞďƌĂŝŶ
ŝƌƌĂĚŝĂƚŝŽŶ͕ĂŶĚͬŽƌƐƚĞƌĞŽƚĂĐƚŝĐƌĂĚŝĂƚŝŽŶƚŚĞƌĂƉǇͿ
ŽŶƚƌĂĐĞƉƚŝŽŶ
ϵ͘ negative urine pregnancy test ĨŽƌĂůůĨĞŵĂůĞƐƵďũĞĐƚƐ;ĞǆĐĞƉƚƉŽƐƚͲŵĞŶŽƉĂƵƐĂůͿĂƚƚŚĞ
^ĐƌĞĞŶŝŶŐsŝƐŝƚĂŶĚĂŶĞŐĂƚŝǀĞƵƌŝŶĞƉƌĞŐŶĂŶĐǇƚĞƐƚĨŽƌĂůůĨĞŵĂůĞƐƵďũĞĐƚƐ;ĞǆĐĞƉƚƉŽƐƚͲ
ŵĞŶŽƉĂƵƐĂůͿĂƚ ďĂƐĞůŝŶĞƉƌŝŽƌƚŽƚŚĞĨŝƌƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ
ϭϬ͘ /ĨĨĞŵĂůĞ͕ŝƐŶŽƚƉƌĞŐŶĂŶƚ͕ďƌĞĂƐƚĨĞĞĚŝŶŐ͕ŽƌĐŽŶƐŝĚĞƌŝŶŐďĞĐŽŵŝŶŐƉƌĞŐŶĂŶƚĚƵƌŝŶŐƚŚĞƐƚƵĚǇ
ŽƌĨŽƌĂƉƉƌŽǆŝŵĂƚĞůǇϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ
ϭϭ͘ &ĞŵĂůĞƐŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂůŵƵƐƚŚĂǀĞĂŶĞŐĂƚŝǀĞƵƌŝŶĞƉƌĞŐŶĂŶĐǇƚĞƐƚƌĞƐƵůƚǁŝƚŚŝŶ
ϳ ĚĂǇƐƉƌŝŽƌƚŽƚŚĞĨŝƌƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͘&ĞŵĂůĞƐŽĨŶŽŶͲĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂůĂƌĞƚŚŽƐĞǁŚŽ
ĂƌĞƉŽƐƚŵĞŶŽƉĂƵƐĂůŐƌĞĂƚĞƌƚŚĂŶϭǇĞĂƌŽƌǁŚŽŚĂǀĞŚĂĚĂďŝůĂƚĞƌĂůƚƵďĂůůŝŐĂƚŝŽŶŽƌ
ŚǇƐƚĞƌĞĐƚŽŵǇ
ϭϮ͘ &ĞŵĂůĞƐŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂůĂŶĚŵĂůĞƐǁŚŽŚĂǀĞƉĂƌƚŶĞƌƐŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂů
ŵƵƐƚĂŐƌĞĞƚŽƵƐĞĂŶĞĨĨĞĐƚŝǀĞĐŽŶƚƌĂĐĞƉƚŝŽŶŵĞƚŚŽĚ;ƐĞĞ^ĞĐƚŝŽŶ ϱ͘ϮͿĚƵƌŝŶŐƚŚĞƐƚƵĚǇĂŶĚĨŽƌ
ϲ ŵŽŶƚŚƐĨŽůůŽǁŝŶŐƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ
ϭϯ͘ /ĨŵĂůĞ͕ŝƐŶŽƚĐŽŶƐŝĚĞƌŝŶŐĨĂƚŚĞƌŝŶŐĂĐŚŝůĚŽƌĚŽŶĂƚŝŶŐƐƉĞƌŵĚƵƌŝŶŐƚŚĞƐƚƵĚǇŽƌĨŽƌ
ĂƉƉƌŽǆŝŵĂƚĞůǇϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ
WĂŐĞϭϯŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϱ͘Ϯ ŽŶƚƌĂĐĞƉƚŝŽŶZĞĐŽŵŵĞŶĚĂƚŝŽŶƐ
ŽŶƚƌĂĐĞƉƚŝŽŶZĞƋƵŝƌĞŵĞŶƚƐĨŽƌ&ĞŵĂůĞƐ
EŽĐŽŶƚƌĂĐĞƉƚŝŽŶŝƐƌĞƋƵŝƌĞĚĨŽƌĨĞŵĂůĞƐƵďũĞĐƚƐŽĨŶŽŶͲĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂů͕ĚĞĨŝŶĞĚĂƐƚŚŽƐĞǁŚŽĂƌĞ
ƉŽƐƚŵĞŶŽƉĂƵƐĂůĨŽƌŐƌĞĂƚĞƌƚŚĂŶϭǇĞĂƌŽƌǁŚŽŚĂǀĞŚĂĚĂďŝůĂƚĞƌĂůƚƵďĂůůŝŐĂƚŝŽŶŽƌŚǇƐƚĞƌĞĐƚŽŵǇ͘
WŽƐƚŵĞŶŽƉĂƵƐĂůŝƐĚĞĨŝŶĞĚĂƐ͗
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ŐĞхϱϱǇĞĂƌƐǁŝƚŚŶŽŵĞŶƐĞƐĨŽƌϭϮŽƌŵŽƌĞŵŽŶƚŚƐǁŝƚŚŽƵƚĂŶĂůƚĞƌŶĂƚŝǀĞŵĞĚŝĐĂůĐĂƵƐĞ
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ŐĞчϱϱǇĞĂƌƐǁŝƚŚŶŽŵĞŶƐĞƐĨŽƌϭϮŽƌŵŽƌĞŵŽŶƚŚƐǁŝƚŚŽƵƚĂŶĂůƚĞƌŶĂƚŝǀĞŵĞĚŝĐĂůĐĂƵƐĞ
EĂĨŽůůŝĐůĞͲƐƚŝŵƵůĂƚŝŶŐŚŽƌŵŽŶĞ;&^,ͿůĞǀĞůхϰϬ/hͬ>
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OR WĞƌŵĂŶĞŶƚůǇƐƵƌŐŝĐĂůůǇƐƚĞƌŝůĞ;ďŝůĂƚĞƌĂůŽŽƉŚŽƌĞĐƚŽŵǇ͕ďŝůĂƚĞƌĂůƐĂůƉŝŶŐĞĐƚŽŵǇŽƌ
ŚǇƐƚĞƌĞĐƚŽŵǇͿ
&ĞŵĂůĞƐŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂůŵƵƐƚĂŐƌĞĞƚŽƉƌĂĐƚŝĐĞĂƚůĞĂƐƚŽŶĞŽĨƚŚĞĨŽůůŽǁŝŶŐŵĞƚŚŽĚƐŽĨďŝƌƚŚ
ĐŽŶƚƌŽůĂƚĞŶƌŽůůŵĞŶƚ;ŽƌĞĂƌůŝĞƌͿƚŚƌŽƵŐŚĂƚůĞĂƐƚϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͘ĨĨĞĐƚŝǀĞ
ďŝƌƚŚĐŽŶƚƌŽůŝŶĐůƵĚĞƐ͗
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ŽŵďŝŶĞĚ;ĞƐƚƌŽŐĞŶĂŶĚƉƌŽŐĞƐƚŽŐĞŶĐŽŶƚĂŝŶŝŶŐͿŚŽƌŵŽŶĂůďŝƌƚŚĐŽŶƚƌŽů;ŽƌĂů͕ŝŶƚƌĂǀĂŐŝŶĂů͕
ƚƌĂŶƐĚĞƌŵĂůͿĂƐƐŽĐŝĂƚĞĚǁŝƚŚŝŶŚŝďŝƚŝŽŶŽĨŽǀƵůĂƚŝŽŶŝŶŝƚŝĂƚĞĚĂƚůĞĂƐƚϭŵŽŶƚŚƉƌŝŽƌƚŽ
ĞŶƌŽůůŵĞŶƚ
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WƌŽŐĞƐƚŽŐĞŶͲŽŶůǇŚŽƌŵŽŶĂůĐŽŶƚƌĂĐĞƉƚŝŽŶ;ŽƌĂů͕ŝŶũĞĐƚĂďůĞ͕ŝŵƉůĂŶƚĂďůĞͿĂƐƐŽĐŝĂƚĞĚǁŝƚŚ
ŝŶŚŝďŝƚŝŽŶŽĨŽǀƵůĂƚŝŽŶŝŶŝƚŝĂƚĞĚĂƚůĞĂƐƚϭŵŽŶƚŚƉƌŝŽƌƚŽƐƚƵĚǇĂƐĞůŝŶĞĂǇϭ
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ŝůĂƚĞƌĂůƚƵďĂůŽĐĐůƵƐŝŽŶͬůŝŐĂƚŝŽŶ;EŽƚĞ͗ŝůĂƚĞƌĂůƚƵďĂůŽĐĐůƵƐŝŽŶǀŝĂŚǇƐƚĞƌŽƐĐŽƉǇ΀ŝ͘Ğ͕͘ƐƐƵƌĞ΁ŝƐ
ĂĐĐĞƉƚĂďůĞƉƌŽǀŝĚĞĚĂŚǇƐƚĞƌŽƐĂůƉŝŶŐŽŐƌĂŵŚĂƐĐŽŶĨŝƌŵĞĚƐƵĐĐĞƐƐŽĨƚŚĞƉƌŽĐĞĚƵƌĞͿ
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/ŶƚƌĂƵƚĞƌŝŶĞĚĞǀŝĐĞ
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/ŶƚƌĂƵƚĞƌŝŶĞŚŽƌŵŽŶĞͲƌĞůĞĂƐŝŶŐƐǇƐƚĞŵ
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sĂƐĞĐƚŽŵŝǌĞĚƐĞǆƵĂůƉĂƌƚŶĞƌ;ƐͿ͗ƉƌŽǀŝĚĞĚƚŚĞǀĂƐĞĐƚŽŵŝǌĞĚƉĂƌƚŶĞƌŚĂƐƌĞĐĞŝǀĞĚŵĞĚŝĐĂů
ĂƐƐĞƐƐŵĞŶƚŽĨƚŚĞƐƵƌŐŝĐĂůƐƵĐĐĞƐƐĂŶĚŝƐƚŚĞƐŽůĞƐĞǆƵĂůƉĂƌƚŶĞƌŽĨƚŚĞƚƌŝĂůƉĂƌƚŝĐŝƉĂŶƚ
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dƌƵĞĂďƐƚŝŶĞŶĐĞ͗ZĞĨƌĂŝŶŝŶŐĨƌŽŵŚĞƚĞƌŽƐĞǆƵĂůŝŶƚĞƌĐŽƵƌƐĞǁŚĞŶƚŚŝƐŝƐŝŶůŝŶĞǁŝƚŚƚŚĞ
ƉƌĞĨĞƌƌĞĚĂŶĚƵƐƵĂůůŝĨĞƐƚǇůĞŽĨƚŚĞƐƵďũĞĐƚ;EŽƚĞ͗ƉĞƌŝŽĚŝĐĂďƐƚŝŶĞŶĐĞ΀Ğ͘Ő͕͘ĐĂůĞŶĚĂƌ͕ŽǀƵůĂƚŝŽŶ͕
ƐǇŵƉƚŽƚŚĞƌŵĂů͕ƉŽƐƚͲŽǀƵůĂƚŝŽŶŵĞƚŚŽĚƐ΁ĂŶĚǁŝƚŚĚƌĂǁĂůĂƌĞŶŽƚĂĐĐĞƉƚĂďůĞͿ
ŽŶƚƌĂĐĞƉƚŝŽŶZĞƋƵŝƌĞŵĞŶƚƐĨŽƌDĂůĞƐ
EŽĐŽŶƚƌĂĐĞƉƚŝŽŶŝƐƌĞƋƵŝƌĞĚĨŽƌŵĂůĞƐƵďũĞĐƚƐǁŚŽĂƌĞƐƵƌŐŝĐĂůůǇƐƚĞƌŝůĞ;ǀĂƐĞĐƚŽŵǇǁŝƚŚŵĞĚŝĐĂů
ĂƐƐĞƐƐŵĞŶƚĐŽŶĨŝƌŵŝŶŐƐƵƌŐŝĐĂůƐƵĐĐĞƐƐͿŽƌǁŚŽŚĂǀĞĂĨĞŵĂůĞƉĂƌƚŶĞƌƚŚĂƚŝƐƉŽƐƚŵĞŶŽƉĂƵƐĂůŽƌ
ƉĞƌŵĂŶĞŶƚůǇƐƚĞƌŝůĞ;ďŝůĂƚĞƌĂůŽŽƉŚŽƌĞĐƚŽŵǇ͕ďŝůĂƚĞƌĂůƐĂůƉŝŶŐĞĐƚŽŵǇŽƌŚǇƐƚĞƌĞĐƚŽŵǇͿ͘
/ĨĂŵĂůĞƐƵďũĞĐƚŝƐƐĞǆƵĂůůǇĂĐƚŝǀĞǁŝƚŚĨĞŵĂůĞƉĂƌƚŶĞƌ;ƐͿŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂů͕ŚĞŵƵƐƚĂŐƌĞĞƚŽƵƐĞ
ĐŽŶĚŽŵƐƵŶƚŝůϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚ͘/ŶĂĚĚŝƚŝŽŶ͕ĨŽƌƐƵĐŚƐƵďũĞĐƚƐ͗
WĂŐĞϭϰŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
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&ĞŵĂůĞƉĂƌƚŶĞƌ;ƐͿŵƵƐƚƵƐĞĂƚůĞĂƐƚŽŶĞŽĨƚŚĞĐŽŶƚƌĂĐĞƉƚŝǀĞŵĞĂƐƵƌĞƐ;ĂƐĚĞĨŝŶĞĚŝŶƚŚĞ
ƉƌŽƚŽĐŽů ĨŽƌĨĞŵĂůĞƐƚƵĚǇƐƵďũĞĐƚƐŽĨĐŚŝůĚďĞĂƌŝŶŐƉŽƚĞŶƚŝĂůͿ͕Žƌ
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^ƵďũĞĐƚŵƵƐƚƉƌĂĐƚŝĐĞƚƌƵĞĂďƐƚŝŶĞŶĐĞ͕ĚĞĨŝŶĞĚĂƐƌĞĨƌĂŝŶŝŶŐĨƌŽŵŚĞƚĞƌŽƐĞǆƵĂůŝŶƚĞƌĐŽƵƌƐĞ
ǁŚĞŶƚŚŝƐŝƐŝŶůŝŶĞǁŝƚŚƚŚĞƉƌĞĨĞƌƌĞĚĂŶĚƵƐƵĂůůŝĨĞƐƚǇůĞŽĨƚŚĞƐƵďũĞĐƚ͘;EŽƚĞ͗WĞƌŝŽĚŝĐ
ĂďƐƚŝŶĞŶĐĞ΀Ğ͘Ő͕͘ĐĂůĞŶĚĂƌ͕ŽǀƵůĂƚŝŽŶ͕ƐǇŵƉƚŽƚŚĞƌŵĂů͕ƉŽƐƚͲŽǀƵůĂƚŝŽŶŵĞƚŚŽĚƐ΁ĂŶĚǁŝƚŚĚƌĂǁĂů
ĂƌĞŶŽƚĂĐĐĞƉƚĂďůĞͿ
&ƵƌƚŚĞƌ͕ŵĂůĞƐƵďũĞĐƚƐŵƵƐƚĂŐƌĞĞŶŽƚƚŽĚŽŶĂƚĞƐƉĞƌŵĨƌŽŵĞŶƌŽůůŵĞŶƚƚŚƌŽƵŐŚϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞ
ůĂƐƚ ĚŽƐĞŽĨŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚ͘
ϱ͘ϯ WƌŽŚŝďŝƚĞĚDĞĚŝĐĂƚŝŽŶƐĂŶĚdŚĞƌĂƉǇ
EŽƚĂƉƉůŝĐĂďůĞ͘
ϱ͘ϰ WƌŝŽƌĂŶĚŽŶĐŽŵŝƚĂŶƚdŚĞƌĂƉǇ
&ŽƌƐƵďũĞĐƚƐǁŚŽǁŝůůƌĞĐĞŝǀĞƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝŶƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͕ĚĞǆĂŵĞƚŚĂƐŽŶĞϴŵŐ
ƚǁŝĐĞ ĚĂŝůǇ;/ͿŽƌĂŶĞƋƵŝǀĂůĞŶƚĐŽƌƚŝĐŽƐƚĞƌŽŝĚǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚĂƌŽƵŶĚƚŚĞƚŝŵĞŽĨĚŽƐŝŶŐ;ĂǇʹϭ͕
ϭ͕ĂŶĚ ϮͿ͘
ŶǇŵĞĚŝĐĂƚŝŽŶŽƌǀĂĐĐŝŶĞ;ŝŶĐůƵĚŝŶŐŽǀĞƌƚŚĞĐŽƵŶƚĞƌŽƌƉƌĞƐĐƌŝƉƚŝŽŶŵĞĚŝĐŝŶĞƐ͕ǀŝƚĂŵŝŶƐĂŶĚͬŽƌŚĞƌďĂů
ƐƵƉƉůĞŵĞŶƚƐͿƚŚĂƚƚŚĞƐƵďũĞĐƚŝƐƌĞĐĞŝǀŝŶŐĂƚƚŚĞƚŝŵĞŽĨĞŶƌŽůůŵĞŶƚŽƌƌĞĐĞŝǀĞƐĚƵƌŝŶŐƚŚĞƐƚƵĚǇŵƵƐƚďĞ
ƌĞĐŽƌĚĞĚƚŚƌŽƵŐŚƚŚĞƌĞƉŽƌƚŝŶŐǁŝŶĚŽǁ;ϳϬĚĂǇƐĂĨƚĞƌůĂƐƚĚŽƐĞͿ͘ůůĂŶƚŝͲĐĂŶĐĞƌŵĞĚŝĐĂƚŝŽŶŽƌ
ƚƌĞĂƚŵĞŶƚƐǁŝůůďĞĐŽůůĞĐƚĞĚĨŽƌƚŚĞĚƵƌĂƚŝŽŶŽĨƚŚĞƐƚƵĚǇ͘
ϱ͘ϱ tŝƚŚĚƌĂǁĂůŽĨ^ƵďũĞĐƚƐĂŶĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨ^ƚƵĚǇ
ƐƵďũĞĐƚŵĂǇǀŽůƵŶƚĂƌŝůǇǁŝƚŚĚƌĂǁŽƌďĞǁŝƚŚĚƌĂǁŶĨƌŽŵƚŚĞƐƚƵĚǇĂƚĂŶǇƚŝŵĞĨŽƌƌĞĂƐŽŶƐŝŶĐůƵĚŝŶŐ͕
ďƵƚŶŽƚůŝŵŝƚĞĚƚŽ͕ƚŚĞĨŽůůŽǁŝŶŐ͗
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dŚĞƐƵďũĞĐƚǁŝƚŚĚƌĂǁƐĐŽŶƐĞŶƚĨŽƌƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶƚŚĞƐƚƵĚǇ͖
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dŚĞ/ŶǀĞƐƚŝŐĂƚŽƌďĞůŝĞǀĞƐŝƚŝƐŝŶƚŚĞďĞƐƚŝŶƚĞƌĞƐƚŽĨƚŚĞƐƵďũĞĐƚ͖
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^ƵďũĞĐƚŝƐƐŝŐŶŝĨŝĐĂŶƚůǇŶŽŶͲĐŽŵƉůŝĂŶƚǁŝƚŚƐƚƵĚǇƉƌŽĐĞĚƵƌĞƐ͕ǁŚŝĐŚǁŽƵůĚƉƵƚƚŚĞƐƵďũĞĐƚĂƚƌŝƐŬ
ĨŽƌĐŽŶƚŝŶƵĞĚƉĂƌƚŝĐŝƉĂƚŝŽŶ͖
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^ƵďũĞĐƚŝƐůŽƐƚƚŽĨŽůůŽǁͲƵƉŽƌĚŝĞƐ͖
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dŚĞƐƚƵĚǇŝƐƚĞƌŵŝŶĂƚĞĚďǇƚŚĞƐƉŽŶƐŽƌ͘
^ƵďũĞĐƚƐǁŚŽǁŝƚŚĚƌĂǁŽƌĚŝƐĐŽŶƚŝŶƵĞƉƌĞŵĂƚƵƌĞůǇĨƌŽŵƚŚĞƐƚƵĚǇǁŝůůŶŽƚďĞƌĞƉůĂĐĞĚ͘
&ŽƌƐƵďũĞĐƚƐƚŽďĞĐŽŶƐŝĚĞƌĞĚůŽƐƚƚŽĨŽůůŽǁͲƵƉ͕ƌĞĂƐŽŶĂďůĞĂƚƚĞŵƉƚƐŵƵƐƚďĞŵĂĚĞƚŽŽďƚĂŝŶ
ŝŶĨŽƌŵĂƚŝŽŶŽŶƚŚĞĨŝŶĂůƐƚĂƚƵƐŽĨƚŚĞƐƵďũĞĐƚ͘ƚĂŵŝŶŝŵƵŵ͕ϮƚĞůĞƉŚŽŶĞĐĂůůƐŵƵƐƚďĞŵĂĚĞĂŶĚ
ϭ ĐĞƌƚŝĨŝĞĚůĞƚƚĞƌŵƵƐƚďĞƐĞŶƚĂŶĚĚŽĐƵŵĞŶƚĞĚŝŶƚŚĞƐƵďũĞĐƚΖƐƐŽƵƌĐĞĚŽĐƵŵĞŶƚĂƚŝŽŶ͘
WĂŐĞϭϱŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
 ƐƵďũĞĐƚĐĂŶ͗
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ǁŝƚŚĚƌĂǁƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶĐůŝŶŝĐǀŝƐŝƚƐ͕ďƵƚďĞŝŶĐůƵĚĞĚŝŶƚŚĞĨŽůůŽǁͲƵƉĨŽƌŽǀĞƌĂůůƐƵƌǀŝǀĂůďǇ
ƉŚŽŶĞĐĂůů͕
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ǁŝƚŚĚƌĂǁƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶƚŚĞŽǀĞƌĂůůƐƵƌǀŝǀĂůĨŽůůŽǁͲƵƉďǇƉŚŽŶĞĐĂůů͕Žƌ
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ǁŝƚŚĚƌĂǁƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶďŽƚŚĐůŝŶŝĐǀŝƐŝƚƐĂŶĚŽǀĞƌĂůů ƐƵƌǀŝǀĂůĨŽůůŽǁͲƵƉďǇƉŚŽŶĞĐĂůů
ďďsŝĞŵĂǇƚĞƌŵŝŶĂƚĞƚŚŝƐƐƚƵĚǇƉƌĞŵĂƚƵƌĞůǇ͕ĞŝƚŚĞƌŝŶŝƚƐĞŶƚŝƌĞƚǇŽƌĂƚĂŶǇƐŝƚĞ͘dŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŵĂǇ
ĂůƐŽƐƚŽƉƚŚĞƐƚƵĚǇĂƚŚŝƐͬŚĞƌƐŝƚĞŝĨŚĞͬƐŚĞŚĂƐƐĂĨĞƚǇĐŽŶĐĞƌŶƐ͘/ĨďďsŝĞƚĞƌŵŝŶĂƚĞƐƚŚĞƐƚƵĚǇĨŽƌ
ƐĂĨĞƚǇƌĞĂƐŽŶƐ͕ďďsŝĞǁŝůůƉƌŽŵƉƚůǇŶŽƚŝĨǇƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌ͘
&ŽůůŽǁͲƵƉƉƌŽĐĞĚƵƌĞƐĂŶĚƐƵƌǀŝǀĂůŝŶĨŽƌŵĂƚŝŽŶĐŽůůĞĐƚŝŽŶĂƌĞĚĞƐĐƌŝďĞĚďĞůŽǁŝŶ^ĞĐƚŝŽŶϱ͘ϲ͘
ϱ͘ϲ &ŽůůŽǁͲhƉĨŽƌ^ƵďũĞĐƚtŝƚŚĚƌĂǁĂůĨƌŽŵ^ƚƵĚǇ
dŽŵŝŶŝŵŝǌĞŵŝƐƐŝŶŐĚĂƚĂĨŽƌĞĨĨŝĐĂĐǇĂŶĚƐĂĨĞƚǇĂƐƐĞƐƐŵĞŶƚƐ͕ƐƵďũĞĐƚƐǁŚŽƉƌĞŵĂƚƵƌĞůǇĚŝƐĐŽŶƚŝŶƵĞ
ƐƚƵĚǇĚƌƵŐƚƌĞĂƚŵĞŶƚƐŚŽƵůĚĐŽŶƚŝŶƵĞƚŽďĞĨŽůůŽǁĞĚĨŽƌĂůůƌĞŐƵůĂƌůǇƐĐŚĞĚƵůĞĚǀŝƐŝƚƐ͕ƵŶůĞƐƐƐƵďũĞĐƚƐ
ŚĂǀĞĚĞĐŝĚĞĚƚŽĚŝƐĐŽŶƚŝŶƵĞƚŚĞƐƚƵĚǇƉĂƌƚŝĐŝƉĂƚŝŽŶĞŶƚŝƌĞůǇ;ǁŝƚŚĚƌĂǁĂůŽĨŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚͿ͘^ƵďũĞĐƚƐ
ƐŚŽƵůĚďĞĂĚǀŝƐĞĚŽŶƚŚĞĐŽŶƚŝŶƵĞĚƐĐŝĞŶƚŝĨŝĐŝŵƉŽƌƚĂŶĐĞŽĨƚŚĞŝƌĚĂƚĂĞǀĞŶŝĨƚŚĞǇĚŝƐĐŽŶƚŝŶƵĞ
ƚƌĞĂƚŵĞŶƚǁŝƚŚƐƚƵĚǇĚƌƵŐĞĂƌůǇ͘
/ĨĂƐƵďũĞĐƚƉƌĞŵĂƚƵƌĞůǇĚŝƐĐŽŶƚŝŶƵĞƐƐƚƵĚǇƉĂƌƚŝĐŝƉĂƚŝŽŶ;ǁŝƚŚĚƌĂǁĂůŽĨŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚͿ͕ƚŚĞ
ƉƌŽĐĞĚƵƌĞƐŽƵƚůŝŶĞĚĨŽƌƚŚĞWƌĞŵĂƚƵƌĞdĞƌŵŝŶĂƚŝŽŶ&ŽůůŽǁhƉ;Wd&hǀŝƐŝƚͿƐŚŽƵůĚďĞĐŽŵƉůĞƚĞĚĂƐƐŽŽŶ
ĂƐƉŽƐƐŝďůĞ͕ƉƌĞĨĞƌĂďůǇǁŝƚŚŝŶϮǁĞĞŬƐ͘ůůĂƚƚĞŵƉƚƐŵƵƐƚďĞŵĂĚĞƚŽĚĞƚĞƌŵŝŶĞƚŚĞĚĂƚĞŽĨƚŚĞůĂƐƚ
ƐƚƵĚǇĚƌƵŐĚŽƐĞĂŶĚƚŚĞƉƌŝŵĂƌǇƌĞĂƐŽŶĨŽƌĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨƐƚƵĚǇĚƌƵŐŽƌƐƚƵĚǇƉĂƌƚŝĐŝƉĂƚŝŽŶ͘dŚĞ
ŝŶĨŽƌŵĂƚŝŽŶǁŝůůďĞƌĞĐŽƌĚĞĚŽŶƚŚĞĂƉƉƌŽƉƌŝĂƚĞĞůĞĐƚƌŽŶŝĐĂƐĞZĞƉŽƌƚ&Žƌŵ;ĞZ&ͿƉĂŐĞ͘,ŽǁĞǀĞƌ͕
ƚŚĞƐĞƉƌŽĐĞĚƵƌĞƐƐŚŽƵůĚŶŽƚŝŶƚĞƌĨĞƌĞǁŝƚŚƚŚĞŝŶŝƚŝĂƚŝŽŶŽĨĂŶǇŶĞǁƚƌĞĂƚŵĞŶƚƐŽƌƚŚĞƌĂƉĞƵƚŝĐ
ŵŽĚĂůŝƚŝĞƐƚŚĂƚƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌĨĞĞůƐĂƌĞŶĞĐĞƐƐĂƌǇƚŽƚƌĞĂƚƚŚĞƐƵďũĞĐƚΖƐĐŽŶĚŝƚŝŽŶ͘&ŽůůŽǁŝŶŐ
ĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨƐƚƵĚǇĚƌƵŐ͕ƚŚĞƐƵďũĞĐƚǁŝůůďĞƚƌĞĂƚĞĚŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌΖƐďĞƐƚ
ĐůŝŶŝĐĂůũƵĚŐŵĞŶƚ͕ŝƌƌĞƐƉĞĐƚŝǀĞŽĨǁŚĞƚŚĞƌŽƌŶŽƚƚŚĞƐƵďũĞĐƚĚĞĐŝĚĞƐƚŽĐŽŶƚŝŶƵĞƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶƚŚĞ
ƐƚƵĚǇ͘
^ƵďũĞĐƚƐŶŽůŽŶŐĞƌƵŶĚĞƌŐŽŝŶŐĐůŝŶŝĐĂůĂƐƐĞƐƐŵĞŶƚƐǁŝůůŚĂǀĞƐƵƌǀŝǀĂůŝŶĨŽƌŵĂƚŝŽŶĐŽůůĞĐƚĞĚ
ĂƉƉƌŽǆŝŵĂƚĞůǇĞǀĞƌǇϲ ǁĞĞŬƐƵŶƚŝůƚŚĞĞŶĚƉŽŝŶƚŽĨĚĞĂƚŚ͕ƚŚĞƐƵďũĞĐƚďĞĐŽŵĞƐůŽƐƚƚŽĨŽůůŽǁͲƵƉŽƌ
ǁŝƚŚĚƌĂǁƐĐŽŶƐĞŶƚ͕ŽƌƚĞƌŵŝŶĂƚŝŽŶŽĨƚŚĞƐƚƵĚǇďǇďďsŝĞ͕ǁŚŝĐŚĞǀĞƌŽĐĐƵƌƐĨŝƌƐƚ͘/ŶĂĚĚŝƚŝŽŶ͕ŝĨƚŚĞ
ƐƵďũĞĐƚŝƐǁŝůůŝŶŐ͕ĂϳϬͲĚĂǇĨŽůůŽǁͲƵƉƉŚŽŶĞĐĂůůĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐŵĂǇďĞĐŽŵƉůĞƚĞĚƚŽ
ĞŶƐƵƌĞĂůůƚƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚƐͬ^ƐŚĂǀĞďĞĞŶƌĞƐŽůǀĞĚ͘
ϱ͘ϳ ^ƚƵĚǇƌƵŐ
&ŽƌƐƵďũĞĐƚƐƌĞĐĞŝǀŝŶŐƐƚƵĚǇĚƌƵŐ͕ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ;Ϭ͘ϯŵŐͬŬŐŽƌĂĚũƵƐƚĞĚĚŽƐĞͿƐƵƉƉůŝĞĚďǇ
ďďsŝĞǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚŝŶƚƌĂǀĞŶŽƵƐůǇ;/sͿŽŶĐĞĞǀĞƌǇϲǁĞĞŬƐďĞŐŝŶŶŝŶŐŽŶĂǇϭ;ĚĂǇŽĨĚŽƐŝŶŐͿ
ĨŽƌϮĚŽƐĞƐ;ĐǇĐůĞƐͿƉĞƌƐƵďũĞĐƚŝŶ^ƚƵĚǇƌŵ;KƉƚŝŽŶĂůZĞƚƌĞĂƚŵĞŶƚͿŽƌŽŶĐĞĞǀĞƌǇϲǁĞĞŬƐďĞŐŝŶŶŝŶŐ
ŽŶĂǇϭ;ĚĂǇŽĨĚŽƐŝŶŐͿŽŵŝƚƚŝŶŐĞǀĞƌǇƚŚŝƌĚĐǇĐůĞƵŶƚŝůĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶŽƌƐƚƵĚǇĚƌƵŐ
ĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŝŶ^ƚƵĚǇƌŵ͘KƌĂůĚĞǆĂŵĞƚŚĂƐŽŶĞϴŵŐ;ŽƌĂůƚĞƌŶĂƚŝǀĞĐŽƌƚŝĐŽƐƚĞƌŽŝĚĂƚĞƋƵŝǀĂůĞŶƚ
WĂŐĞϭϲŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ĚŽƐŝŶŐͿǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚƚǁŝĐĞĚĂŝůǇ;/ͿŽŶĂǇʹϭ͕ĂǇϭ͕ĂŶĚĂǇϮĨŽƌĂůůƐƵďũĞĐƚƐƌĞĐĞŝǀŝŶŐ
ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘
ďďsŝĞǁŝůůŶŽƚƌŽƵƚŝŶĞůǇƐƵƉƉůǇĚƌƵŐŽƚŚĞƌƚŚĂŶƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘ďďsŝĞǁŝůůŶŽƚƌŽƵƚŝŶĞůǇ
ƉƌŽǀŝĚĞĚĞǆĂŵĞƚŚĂƐŽŶĞ;ŽƌŝƚƐĞƋƵŝǀĂůĞŶƚͿƵŶůĞƐƐƐƉĞĐŝĨŝĞĚŝŶŽƉĞƌĂƚŝŽŶĂůŽƌƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ
;ŝ͘Ğ͕͘ůŽĐĂůƐŝƚĞͬĐŽƵŶƚƌǇͲƐƉĞĐŝĨŝĐƌĞƋƵŝƌĞŵĞŶƚƐͿ͘EŽŶͲŝŶǀĞƐƚŝŐĂƚŝŽŶĂůŵĞĚŝĐŝŶĂůƉƌŽĚƵĐƚ;ƐƚĂŶĚĂƌĚŽĨĐĂƌĞͿ
ŵƵƐƚďĞŽďƚĂŝŶĞĚĐŽŵŵĞƌĐŝĂůůǇ͘
/ŶƐƚƌƵĐƚŝŽŶƐĨŽƌĚƌƵŐƉƌĞƉĂƌĂƚŝŽŶǁŝůůďĞƉƌŽǀŝĚĞĚďǇďďsŝĞ͘&ƵƌƚŚĞƌĚĞƚĂŝůƐĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞ
KƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϲ͘
ϱ͘ϴ ZĂŶĚŽŵŝǌĂƚŝŽŶͬƌƵŐƐƐŝŐŶŵĞŶƚ
ƐƐƵďũĞĐƚƐĂƌĞĞŶƌŽůůĞĚŝŶƚŚĞƐƚƵĚǇ͕ƚŚĞǇǁŝůůďĞĐůĂƐƐŝĨŝĞĚŝŶƚŽƚŚĞϮƐƚƵĚǇĂƌŵƐ;ŽƌͿ͕ ĂŶĚǁŝůůďĞ
ŐŝǀĞŶĂƵŶŝƋƵĞƐƵďũĞĐƚŝĚĞŶƚŝĨŝĐĂƚŝŽŶŶƵŵďĞƌ͘ZŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞǁŝůůďĞĚŝƐƉĞŶƐĞĚƵƐŝŶŐĂŶ
/ŶƚĞƌĂĐƚŝǀĞZĞƐƉŽŶƐĞdĞĐŚŶŽůŽŐǇ;/ZdͿĂƚƚŚĞƐƚƵĚǇǀŝƐŝƚƐ͕ĂƐƐƵŵŵĂƌŝǌĞĚŝŶ^ĞĐƚŝŽŶϱ͘ϳ͕ĨŽƌƐƵďũĞĐƚƐŝŶ
^ƚƵĚǇƌŵ;KƉƚŝŽŶĂůZĞƚƌĞĂƚŵĞŶƚͿŽƌ^ƚƵĚǇƌŵ͘
ϱ͘ϵ WƌŽƚŽĐŽůĞǀŝĂƚŝŽŶƐ
dŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŝƐƌĞƐƉŽŶƐŝďůĞĨŽƌĐŽŵƉůǇŝŶŐǁŝƚŚĂůůƉƌŽƚŽĐŽůƌĞƋƵŝƌĞŵĞŶƚƐ͕ǁƌŝƚƚĞŶŝŶƐƚƌƵĐƚŝŽŶƐĂŶĚ
ĂƉƉůŝĐĂďůĞůĂǁƐƌĞŐĂƌĚŝŶŐƉƌŽƚŽĐŽůĚĞǀŝĂƚŝŽŶƐ͘WƌŽƚŽĐŽůĚĞǀŝĂƚŝŽŶƐĂƌĞƉƌŽŚŝďŝƚĞĚĞǆĐĞƉƚǁŚĞŶ
ŶĞĐĞƐƐĂƌǇƚŽĞůŝŵŝŶĂƚĞĂŶŝŵŵĞĚŝĂƚĞŚĂǌĂƌĚƚŽƐƚƵĚǇƐƵďũĞĐƚƐ͘/ĨĂƉƌŽƚŽĐŽůĚĞǀŝĂƚŝŽŶŽĐĐƵƌƐ;ŽƌŝƐ
ŝĚĞŶƚŝĨŝĞĚͿ͕ƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŝƐƌĞƐƉŽŶƐŝďůĞĨŽƌŶŽƚŝĨǇŝŶŐ/ͬ/Z;ĂƐĂƉƉůŝĐĂďůĞͿ͕ƌĞŐƵůĂƚŽƌǇĂƵƚŚŽƌŝƚŝĞƐ;ĂƐ
ĂƉƉůŝĐĂďůĞͿĂŶĚďďsŝĞ͘
ϲ ^&dzKE^/Zd/KE^
ϲ͘ϭ ŽŵƉůĂŝŶƚƐĂŶĚĚǀĞƌƐĞǀĞŶƚƐ
ŽŵƉůĂŝŶƚƐ
ĐŽŵƉůĂŝŶƚŝƐĂŶǇǁƌŝƚƚĞŶ͕ĞůĞĐƚƌŽŶŝĐ͕ŽƌŽƌĂůĐŽŵŵƵŶŝĐĂƚŝŽŶƚŚĂƚĂůůĞŐĞƐĚĞĨŝĐŝĞŶĐŝĞƐƌĞůĂƚĞĚƚŽƚŚĞ
ƉŚǇƐŝĐĂůĐŚĂƌĂĐƚĞƌŝƐƚŝĐƐ͕ŝĚĞŶƚŝƚǇ͕ƋƵĂůŝƚǇ͕ƉƵƌŝƚǇ͕ƉŽƚĞŶĐǇ͕ĚƵƌĂďŝůŝƚǇ͕ƌĞůŝĂďŝůŝƚǇ͕ƐĂĨĞƚǇ͕ĞĨĨĞĐƚŝǀĞŶĞƐƐ͕Žƌ
ƉĞƌĨŽƌŵĂŶĐĞŽĨĂƉƌŽĚƵĐƚͬĚĞǀŝĐĞ͘ŽŵƉůĂŝŶƚƐĂƐƐŽĐŝĂƚĞĚǁŝƚŚĂŶǇĐŽŵƉŽŶĞŶƚŽĨƚŚŝƐŝŶǀĞƐƚŝŐĂƚŝŽŶĂů
ƉƌŽĚƵĐƚŵƵƐƚďĞƌĞƉŽƌƚĞĚƚŽďďsŝĞ͘
DĞĚŝĐĂůŽŵƉůĂŝŶƚƐͬĚǀĞƌƐĞǀĞŶƚƐĂŶĚ^ĞƌŝŽƵƐĚǀĞƌƐĞǀĞŶƚƐ
ŶŝƐĚĞĨŝŶĞĚĂƐĂŶǇƵŶƚŽǁĂƌĚŵĞĚŝĐĂůŽĐĐƵƌƌĞŶĐĞŝŶĂƐƵďũĞĐƚŽƌĐůŝŶŝĐĂůŝŶǀĞƐƚŝŐĂƚŝŽŶƐƵďũĞĐƚ
ĂĚŵŝŶŝƐƚĞƌĞĚĂƉŚĂƌŵĂĐĞƵƚŝĐĂůƉƌŽĚƵĐƚĂŶĚǁŚŝĐŚĚŽĞƐŶŽƚŶĞĐĞƐƐĂƌŝůǇŚĂǀĞĂĐĂƵƐĂůƌĞůĂƚŝŽŶƐŚŝƉǁŝƚŚ
ƚŚŝƐƚƌĞĂƚŵĞŶƚ͘ŶĐĂŶƚŚĞƌĞĨŽƌĞďĞĂŶǇƵŶĨĂǀŽƌĂďůĞĂŶĚƵŶŝŶƚĞŶĚĞĚƐŝŐŶ;ŝŶĐůƵĚŝŶŐĂŶĂďŶŽƌŵĂů
ůĂďŽƌĂƚŽƌǇĨŝŶĚŝŶŐͿ͕ƐǇŵƉƚŽŵ͕ŽƌĚŝƐĞĂƐĞƚĞŵƉŽƌĂůůǇĂƐƐŽĐŝĂƚĞĚǁŝƚŚƚŚĞƵƐĞŽĨĂŵĞĚŝĐŝŶĂů
;ŝŶǀĞƐƚŝŐĂƚŝŽŶĂůͿƉƌŽĚƵĐƚ͕ǁŚĞƚŚĞƌŽƌŶŽƚƚŚĞĞǀĞŶƚŝƐĐŽŶƐŝĚĞƌĞĚĐĂƵƐĂůůǇƌĞůĂƚĞĚƚŽƚŚĞƵƐĞŽĨƚŚĞ
ƉƌŽĚƵĐƚ͘
WĂŐĞϭϳŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
dŚĞŝŶǀĞƐƚŝŐĂƚŽƌƐǁŝůůŵŽŶŝƚŽƌĞĂĐŚƐƵďũĞĐƚĨŽƌĐůŝŶŝĐĂůĂŶĚůĂďŽƌĂƚŽƌǇĞǀŝĚĞŶĐĞŽĨĂĚǀĞƌƐĞĞǀĞŶƚƐŽŶĂ
ƌŽƵƚŝŶĞďĂƐŝƐƚŚƌŽƵŐŚŽƵƚƚŚĞƐƚƵĚǇ͘ůůƐǁŝůůďĞĨŽůůŽǁĞĚƚŽĂƐĂƚŝƐĨĂĐƚŽƌǇĐŽŶĐůƵƐŝŽŶ͘
/ĨĂŶŵĞĞƚƐĂŶǇŽĨƚŚĞĨŽůůŽǁŝŶŐĐƌŝƚĞƌŝĂ͕ ŝƚŝƐƚŽďĞƌĞƉŽƌƚĞĚƚŽďďsŝĞĂƐĂ^ǁŝƚŚŝŶϮϰŚŽƵƌƐŽĨƚŚĞ
ƐŝƚĞďĞŝŶŐŵĂĚĞĂǁĂƌĞŽĨƚŚĞĞǀĞŶƚ͗
Death of Subject
ŶĞǀĞŶƚƚŚĂƚƌĞƐƵůƚƐŝŶƚŚĞĚĞĂƚŚŽĨĂƐƵďũĞĐƚ͘
Life-Threatening
ŶĞǀĞŶƚƚŚĂƚ͕ŝŶƚŚĞŽƉŝŶŝŽŶŽĨƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌ͕ǁŽƵůĚŚĂǀĞƌĞƐƵůƚĞĚŝŶ
ŝŵŵĞĚŝĂƚĞĨĂƚĂůŝƚǇŝĨŵĞĚŝĐĂůŝŶƚĞƌǀĞŶƚŝŽŶŚĂĚŶŽƚďĞĞŶƚĂŬĞŶ͘dŚŝƐĚŽĞƐ
ŶŽƚŝŶĐůƵĚĞĂŶĞǀĞŶƚƚŚĂƚǁŽƵůĚŚĂǀĞďĞĞŶĨĂƚĂůŝĨŝƚŚĂĚŽĐĐƵƌƌĞĚŝŶĂ
ŵŽƌĞƐĞǀĞƌĞĨŽƌŵ͘
Hospitalization or 
Prolongation of 
Hospitalization
ŶĞǀĞŶƚƚŚĂƚƌĞƐƵůƚƐŝŶĂŶĂĚŵŝƐƐŝŽŶƚŽƚŚĞŚŽƐƉŝƚĂůĨŽƌĂŶǇůĞŶŐƚŚŽĨ
ƚŝŵĞŽƌƉƌŽůŽŶŐƐƚŚĞƐƵďũĞĐƚΖƐŚŽƐƉŝƚĂůƐƚĂǇ͘dŚŝƐĚŽĞƐŶŽƚŝŶĐůƵĚĞĂŶ
ĞŵĞƌŐĞŶĐǇƌŽŽŵǀŝƐŝƚ͕ĂĚŵŝƐƐŝŽŶƚŽĂŶŽƵƚƉĂƚŝĞŶƚĨĂĐŝůŝƚǇ͕ƌĞƐƉŝƚĞ͕Žƌ
ŚŽƐƉŝĐĞĐĂƌĞ͘
Congenital Anomaly
ŶĂŶŽŵĂůǇĚĞƚĞĐƚĞĚĂƚŽƌĂĨƚĞƌďŝƌƚŚŽƌĂŶǇĂŶŽŵĂůǇƚŚĂƚƌĞƐƵůƚŝŶĨĞƚĂů
ůŽƐƐ͘
Persistent or Significant 
Disability/Incapacity
ŶĞǀĞŶƚƚŚĂƚƌĞƐƵůƚƐŝŶĂĐŽŶĚŝƚŝŽŶƚŚĂƚƐƵďƐƚĂŶƚŝĂůůǇŝŶƚĞƌĨĞƌĞƐǁŝƚŚƚŚĞ
ĂĐƚŝǀŝƚŝĞƐŽĨĚĂŝůǇůŝǀŝŶŐŽĨĂƐƚƵĚǇƐƵďũĞĐƚ͘ŝƐĂďŝůŝƚǇŝƐŶŽƚŝŶƚĞŶĚĞĚƚŽ
ŝŶĐůƵĚĞĞǆƉĞƌŝĞŶĐĞƐŽĨƌĞůĂƚŝǀĞůǇŵŝŶŽƌŵĞĚŝĐĂůƐŝŐŶŝĨŝĐĂŶĐĞƐƵĐŚĂƐ
ŚĞĂĚĂĐŚĞ͕ŶĂƵƐĞĂ͕ǀŽŵŝƚŝŶŐ͕ĚŝĂƌƌŚĞĂ͕ŝŶĨůƵĞŶǌĂ͕ĂŶĚĂĐĐŝĚĞŶƚĂůƚƌĂƵŵĂ
;Ğ͘Ő͕͘ƐƉƌĂŝŶĞĚĂŶŬůĞͿ͘
Important Medical Event 
Requiring Medical or 
Surgical Intervention to 
Prevent Serious Outcome
ŶŝŵƉŽƌƚĂŶƚŵĞĚŝĐĂůĞǀĞŶƚƚŚĂƚŵĂǇŶŽƚďĞŝŵŵĞĚŝĂƚĞůǇ
ůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐŽƌƌĞƐƵůƚŝŶĚĞĂƚŚŽƌŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ͕ďƵƚďĂƐĞĚŽŶ
ŵĞĚŝĐĂůũƵĚŐŵĞŶƚŵĂǇũĞŽƉĂƌĚŝǌĞƚŚĞƐƵďũĞĐƚĂŶĚŵĂǇƌĞƋƵŝƌĞŵĞĚŝĐĂů
ŽƌƐƵƌŐŝĐĂůŝŶƚĞƌǀĞŶƚŝŽŶƚŽƉƌĞǀĞŶƚĂŶǇŽĨƚŚĞŽƵƚĐŽŵĞƐůŝƐƚĞĚĂďŽǀĞ
;ŝ͘Ğ͕͘ ĚĞĂƚŚŽĨƐƵďũĞĐƚ͕ůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐ͕ŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ͕ƉƌŽůŽŶŐĂƚŝŽŶŽĨ
ŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ͕ĐŽŶŐĞŶŝƚĂůĂŶŽŵĂůǇ͕ŽƌƉĞƌƐŝƐƚĞŶƚŽƌƐŝŐŶŝĨŝĐĂŶƚ
ĚŝƐĂďŝůŝƚǇͬŝŶĐĂƉĂĐŝƚǇͿ͘ĚĚŝƚŝŽŶĂůůǇ͕ĂŶǇĞůĞĐƚŝǀĞŽƌƐƉŽŶƚĂŶĞŽƵƐĂďŽƌƚŝŽŶ
ŽƌƐƚŝůůďŝƌƚŚŝƐĐŽŶƐŝĚĞƌĞĚĂŶŝŵƉŽƌƚĂŶƚŵĞĚŝĐĂů ĞǀĞŶƚ͘ǆĂŵƉůĞƐŽĨƐƵĐŚ
ĞǀĞŶƚƐŝŶĐůƵĚĞĂůůĞƌŐŝĐďƌŽŶĐŚŽƐƉĂƐŵƌĞƋƵŝƌŝŶŐŝŶƚĞŶƐŝǀĞƚƌĞĂƚŵĞŶƚŝŶĂŶ
ĞŵĞƌŐĞŶĐǇƌŽŽŵŽƌĂƚŚŽŵĞ͕ďůŽŽĚĚǇƐĐƌĂƐŝĂƐŽƌĐŽŶǀƵůƐŝŽŶƐƚŚĂƚĚŽŶŽƚ
ƌĞƐƵůƚŝŶŝŶƉĂƚŝĞŶƚŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ͕ŽƌƚŚĞĚĞǀĞůŽƉŵĞŶƚŽĨĚƌƵŐ
ĚĞƉĞŶĚĞŶĐǇŽƌĚƌƵŐĂďƵƐĞ͘
&ƵƌƚŚĞƌĚĞƚĂŝůƐŽŶƐĂŶĚ^ĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘
ďďsŝĞǁŝůůďĞƌĞƐƉŽŶƐŝďůĞĨŽƌ^ƵƐƉĞĐƚĞĚhŶĞǆƉĞĐƚĞĚ^ĞƌŝŽƵƐĚǀĞƌƐĞZĞĂĐƚŝŽŶƐ;^h^ZͿƌĞƉŽƌƚŝŶŐĨŽƌ
ƚŚĞ/ŶǀĞƐƚŝŐĂƚŝŽŶĂůDĞĚŝĐŝŶĂůWƌŽĚƵĐƚ;/DWͿŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚŐůŽďĂůĂŶĚůŽĐĂůŐƵŝĚĞůŝŶĞƐ͘
WĂŐĞϭϴŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ĚǀĞƌƐĞǀĞŶƚ^ĞǀĞƌŝƚǇĂŶĚZĞůĂƚŝŽŶƐŚŝƉƚŽ^ƚƵĚǇƌƵŐ
dŚĞŝŶǀĞƐƚŝŐĂƚŽƌƐǁŝůůƌĂƚĞƚŚĞƐĞǀĞƌŝƚǇŽĨĞĂĐŚĂĚǀĞƌƐĞĞǀĞŶƚĂƐŵŝůĚ;ŐƌĂĚĞϭͿ͕ŵŽĚĞƌĂƚĞ;ŐƌĂĚĞϮͿ͕
ƐĞǀĞƌĞ;ŐƌĂĚĞϯͿ͕ŽƌůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐ;ŐƌĂĚĞϰͿ͘dŚĞŝŶǀĞƐƚŝŐĂƚŽƌǁŝůůƵƐĞƚŚĞĨŽůůŽǁŝŶŐĚĞĨŝŶŝƚŝŽŶƐƚŽ
ĂƐƐĞƐƐƚŚĞƌĞůĂƚŝŽŶƐŚŝƉŽĨƚŚĞĂĚǀĞƌƐĞĞǀĞŶƚƚŽƚŚĞƵƐĞŽĨ ƐƚƵĚǇĚƌƵŐ͗
Reasonable Possibility – ĨƚĞƌĐŽŶƐŝĚĞƌĂƚŝŽŶŽĨĨĂĐƚŽƌƐŝŶĐůƵĚŝŶŐƚŝŵŝŶŐŽĨƚŚĞĞǀĞŶƚ͕ďŝŽůŽŐŝĐƉůĂƵƐŝďŝůŝƚǇ͕
ĐůŝŶŝĐĂůũƵĚŐŵĞŶƚ͕ĂŶĚƉŽƚĞŶƚŝĂůĂůƚĞƌŶĂƚŝǀĞĐĂƵƐĞƐ͕ƚŚĞƌĞŝƐƐƵĨĨŝĐŝĞŶƚĞǀŝĚĞŶĐĞ;ŝŶĨŽƌŵĂƚŝŽŶͿƚŽƐƵŐŐĞƐƚ
ĂĐĂƵƐĂůƌĞůĂƚŝŽŶƐŚŝƉ͘
No Reasonable Possibility – ĨƚĞƌĐŽŶƐŝĚĞƌĂƚŝŽŶŽĨĨĂĐƚŽƌƐŝŶĐůƵĚŝŶŐƚŝŵŝŶŐŽĨƚŚĞĞǀĞŶƚ͕ďŝŽůŽŐŝĐ
ƉůĂƵƐŝďŝůŝƚǇ͕ĐůŝŶŝĐĂůũƵĚŐŵĞŶƚ͕ĂŶĚƉŽƚĞŶƚŝĂůĂůƚĞƌŶĂƚŝǀĞĐĂƵƐĞƐ͕ƚŚĞƌĞŝƐŝŶƐƵĨĨŝĐŝĞŶƚĞǀŝĚĞŶĐĞ
;ŝŶĨŽƌŵĂƚŝŽŶͿƚŽƐƵŐŐĞƐƚĂĐĂƵƐĂůƌĞůĂƚŝŽŶƐŚŝƉ͘
ĚǀĞƌƐĞǀĞŶƚƐ ƵĞƚŽĂŶĐĞƌWƌŽŐƌĞƐƐŝŽŶĂŶĚWƌŽŐƌĞƐƐŝŽŶŽĨƚŚĞhŶĚĞƌůǇŝŶŐĂŶĐĞƌ
ĞƌƚĂŝŶƐĂƌĞĂŶƚŝĐŝƉĂƚĞĚƚŽŽĐĐƵƌŝŶƚŚŝƐƐƚƵĚǇƉŽƉƵůĂƚŝŽŶĂƚƐŽŵĞĨƌĞƋƵĞŶĐǇŝŶĚĞƉĞŶĚĞŶƚŽĨĚƌƵŐ
ĞǆƉŽƐƵƌĞ͘^ƵĐŚĞǀĞŶƚƐŝŶĐůƵĚĞŬŶŽǁŶĐŽŶƐĞƋƵĞŶĐĞƐŽĨƚŚĞƵŶĚĞƌůǇŝŶŐĚŝƐĞĂƐĞŽƌĐŽŶĚŝƚŝŽŶ ƵŶĚĞƌ
ŝŶǀĞƐƚŝŐĂƚŝŽŶ;Ğ͘Ő͕͘ƐǇŵƉƚŽŵƐ͕ĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶͿ͘dŚĞƐĞƐŵĂǇŽĐĐƵƌĂůŽŶĞŽƌŝŶǀĂƌŝŽƵƐ
ĐŽŵďŝŶĂƚŝŽŶƐĂŶĚĂƌĞĐŽŶƐŝĚĞƌĞĚĞǆƉĞĐƚĞĚƐŝŶƐƵďũĞĐƚƐĂŶĚĨŽƌƌĞƉŽƌƚŝŶŐƉƵƌƉŽƐĞƐĨŽƌƚŚŝƐƉƌŽƚŽĐŽů͘
ΗŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶΗƐŚŽƵůĚŶŽƚďĞĐĂƉƚƵƌĞĚǁŚĞŶƌĞƉŽƌƚŝŶŐƐŽƌ^Ɛ͕ĞǀĞŶŝĨĨĂƚĂů͕ĂƐĚŝƐĞĂƐĞ
ƉƌŽŐƌĞƐƐŝŽŶǁŝůůďĞĐĂƉƚƵƌĞĚĂƐĞĨĨŝĐĂĐǇŽƵƚĐŽŵĞƐŝŶƚŚĞƚƌŝĂů͘ZĂƚŚĞƌ͕ƐǇŵƉƚŽŵƐŽĨĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶ
ƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚĂƐƐŽƌ^ƐĂŶĚƚŚĞĚŝƐƚŝŶĐƚŝŽŶŽŶƚŚĞĞZ&ŵĂƌŬĞĚĂƐĂƉƉƌŽƉƌŝĂƚĞ͘
ĞĂƚŚƐƵĞ ƚŽĂŶĐĞƌWƌŽŐƌĞƐƐŝŽŶ
&Žƌ^ƐǁŝƚŚƚŚĞŽƵƚĐŽŵĞŽĨĚĞĂƚŚ͕ƚŚĞĚĂƚĞĂŶĚĐĂƵƐĞŽĨĚĞĂƚŚǁŝůůďĞƌĞĐŽƌĚĞĚŽŶƚŚĞĂƉƉƌŽƉƌŝĂƚĞ
ĞZ&͘&ƵƌƚŚĞƌĚĞƚĂŝůƐĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϭ͘
WƌĞŐŶĂŶĐǇ
WƌĞŐŶĂŶĐǇŝŶĂƐƚƵĚǇƐƵďũĞĐƚŵƵƐƚďĞƌĞƉŽƌƚĞĚƚŽ ďďsŝĞǁŝƚŚŝŶϭǁŽƌŬŝŶŐĚĂǇŽĨƚŚĞƐŝƚĞďĞĐŽŵŝŶŐ
ĂǁĂƌĞŽĨƚŚĞƉƌĞŐŶĂŶĐǇ͘^ƵďũĞĐƚƐǁŚŽďĞĐŽŵĞƉƌĞŐŶĂŶƚĚƵƌŝŶŐƚŚĞƐƚƵĚǇŵƵƐƚĚŝƐĐŽŶƚŝŶƵĞƐƚƵĚǇĚƌƵŐ͘
ůůƐƵďũĞĐƚƐƐŚŽƵůĚďĞŝŶĨŽƌŵĞĚƚŚĂƚĐŽŶƚƌĂĐĞƉƚŝǀĞŵĞĂƐƵƌĞƐ;ƌĞĨĞƌƚŽ^ĞĐƚŝŽŶϱ͘ϮͿƐŚŽƵůĚďĞƚĂŬĞŶ
ƚŚƌŽƵŐŚŽƵƚƚŚĞƐƚƵĚǇĂŶĚĨŽƌĂƚůĞĂƐƚϲŵŽŶƚŚƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͘DĂůĞƐƵďũĞĐƚƐƐŚŽƵůĚ
ďĞŝŶĨŽƌŵĞĚƚŚĂƚĐŽŶƚƌĂĐĞƉƚŝǀĞŵĞĂƐƵƌĞƐƐŚŽƵůĚďĞƚĂŬĞŶďǇƚŚĞŝƌĨĞŵĂůĞƉĂƌƚŶĞƌ͘
/ŶĨŽƌŵĂƚŝŽŶƌĞŐĂƌĚŝŶŐĂƉƌĞŐŶĂŶĐǇŽĐĐƵƌƌĞŶĐĞŝŶĂƐƚƵĚǇƐƵďũĞĐƚĂŶĚƚŚĞŽƵƚĐŽŵĞŽĨƚŚĞƉƌĞŐŶĂŶĐǇǁŝůů
ďĞĐŽůůĞĐƚĞĚ͘/ŶƚŚĞĞǀĞŶƚŽĨĂƉƌĞŐŶĂŶĐǇŽĐĐƵƌƌŝŶŐŝŶƚŚĞƉĂƌƚŶĞƌŽĨĂŶĞŶƌŽůůĞĚƐƵďũĞĐƚ͕ǁƌŝƚƚĞŶ
ŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚĨŽƌƌĞůĞĂƐĞŽĨŵĞĚŝĐĂůŝŶĨŽƌŵĂƚŝŽŶĨƌŽŵƚŚĞƉĂƌƚŶĞƌŵƵƐƚďĞŽďƚĂŝŶĞĚƉƌŝŽƌƚŽƚŚĞ
ĐŽůůĞĐƚŝŽŶŽĨĂŶǇƉƌĞŐŶĂŶĐǇƐƉĞĐŝĨŝĐŝŶĨŽƌŵĂƚŝŽŶ͕ĂŶĚƚŚĞƉƌĞŐŶĂŶĐǇǁŝůůďĞĨŽůůŽǁĞĚƚŽŽƵƚĐŽŵĞ͘
WƌĞŐŶĂŶĐǇŝŶĂƐƚƵĚǇƐƵďũĞĐƚŝƐŶŽƚĐŽŶƐŝĚĞƌĞĚĂŶ͘dŚĞŵĞĚŝĐĂůŽƵƚĐŽŵĞĨŽƌĞŝƚŚĞƌŵŽƚŚĞƌŽƌŝŶĨĂŶƚ͕
ŵĞĞƚŝŶŐĂŶǇƐĞƌŝŽƵƐĐƌŝƚĞƌŝĂŝŶĐůƵĚŝŶŐĂŶĞůĞĐƚŝǀĞŽƌƐƉŽŶƚĂŶĞŽƵƐĂďŽƌƚŝŽŶ͕ŝƐĐŽŶƐŝĚĞƌĞĚĂ^ĂŶĚŵƵƐƚ
ďĞƌĞƉŽƌƚĞĚƚŽďďsŝĞǁŝƚŚŝŶϮϰŚŽƵƌƐŽĨƚŚĞƐŝƚĞďĞĐŽŵŝŶŐĂǁĂƌĞŽĨƚŚĞĞǀĞŶƚ͘
WĂŐĞϭϵŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϲ͘Ϯ dŽǆŝĐŝƚǇDĂŶĂŐĞŵĞŶƚ
dŚĞŵĂŶĂŐĞŵĞŶƚŽĨƐƉĞĐŝĨŝĐƐĂŶĚůĂďŽƌĂƚŽƌǇƉĂƌĂŵĞƚĞƌƐŝƐĚĞƐĐƌŝďĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕
^ĞĐƚŝŽŶϰ͘ϰ͘&ŽƌƚŚĞƉƵƌƉŽƐĞŽĨŵĞĚŝĐĂůŵĂŶĂŐĞŵĞŶƚ͕ĂůůƐĂŶĚůĂďŽƌĂƚŽƌǇĂďŶŽƌŵĂůŝƚŝĞƐƚŚĂƚŽĐĐƵƌ
ĚƵƌŝŶŐƚŚĞƐƚƵĚǇŵƵƐƚďĞĞǀĂůƵĂƚĞĚďǇƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌ͘dŚĞƚĂďůĞŽĨĐůŝŶŝĐĂůƚŽǆŝĐŝƚǇŐƌĂĚĞƐŵŽĚŝĨŝĞĚ
ĨƌŽŵƚŚĞEĂƚŝŽŶĂůĂŶĐĞƌ/ŶƐƚŝƚƵƚĞ;E/ͿŽŵŵŽŶdĞƌŵŝŶŽůŽŐǇƌŝƚĞƌŝĂĨŽƌĚǀĞƌƐĞǀĞŶƚƐ;dͿ͕
sĞƌƐŝŽŶϰ͘Ϭϯ;ĂǀĂŝůĂďůĞŽŶƚŚĞE/ͲdWŚŽŵĞƉĂŐĞ͕ŚƚƚƉƐ͗ͬͬŶĐŝƚĞƌŵƐ͘ŶĐŝ͘ŶŝŚ͘ŐŽǀͿŝƐƚŽďĞƵƐĞĚŝŶƚŚĞ
ŐƌĂĚŝŶŐŽĨƐĂŶĚůĂďŽƌĂƚŽƌǇĂďŶŽƌŵĂůŝƚŝĞƐ ƚŚĂƚĂƌĞƌĞƉŽƌƚĞĚĂƐƐ͕ĞĂĐŚŽĨǁŚŝĐŚǁŝůůďĞĨŽůůŽǁĞĚƚŽ
ƐĂƚŝƐĨĂĐƚŽƌǇĐůŝŶŝĐĂůƌĞƐŽůƵƚŝŽŶ͘
ƉŽƚĞŶƚŝĂůĚƌƵŐͲƌĞůĂƚĞĚƚŽǆŝĐŝƚǇŝƐĂŶŽƌůĂďŽƌĂƚŽƌǇǀĂůƵĞŽƵƚƐŝĚĞŽĨƚŚĞƌĞĨĞƌĞŶĐĞƌĂŶŐĞƚŚĂƚŝƐ
ũƵĚŐĞĚďǇƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌŽƌďďsŝĞƚŽŚĂǀĞĞŝƚŚĞƌΗƌĞĂƐŽŶĂďůĞƉŽƐƐŝďŝůŝƚǇΗŽƌΗŶŽƌĞĂƐŽŶĂďůĞ
ƉŽƐƐŝďŝůŝƚǇΗŽĨƌĞůĂƚŝŽŶƐŚŝƉƚŽƚŚĞƐƚƵĚǇĚƌƵŐ͘dŽǆŝĐŝƚǇŝƐĚĞĞŵĞĚΗĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚΗďĂƐĞĚŽŶƚŚĞ
ŵĞĚŝĐĂůũƵĚŐŵĞŶƚŽĨƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌ͘dŽǆŝĐŝƚǇŝƐĚĞĨŝŶĞĚĂƐĂŶǇĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚŐƌĂĚĞϯŽƌϰƐƚƵĚǇ
ĚƌƵŐͲƌĞůĂƚĞĚƚŽǆŝĐŝƚǇŽďƐĞƌǀĞĚŝŶϭŽƌŵŽƌĞƐƵďũĞĐƚƐ͘^ƵďũĞĐƚƐǁŚŽĚĞǀĞůŽƉĂƐƚƵĚǇĚƌƵŐͲƌĞůĂƚĞĚŐƌĂĚĞϭ
ŽƌϮŽƌůĂďŽƌĂƚŽƌǇĂďŶŽƌŵĂůŝƚǇŵĂǇĐŽŶƚŝŶƵĞƐƚƵĚǇŵĞĚŝĐĂƚŝŽŶƐ͘
/ĨĂƐƵďũĞĐƚĞǆƉĞƌŝĞŶĐĞƐĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚƚŽǆŝĐŝƚǇĚƵƌŝŶŐĂĐǇĐůĞ͕ĂĚŵŝŶŝƐƚƌĂƚŝŽŶŽĨƚŚĞŶĞǆƚƐĐŚĞĚƵůĞĚ
ĐǇĐůĞƐŚŽƵůĚďĞĚĞůĂǇĞĚƵŶƚŝůƌĞĐŽǀĞƌǇ͘^ƉĞĐŝĨŝĐƌĞĐŽŵŵĞŶĚĂƚŝŽŶƐĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐ
DĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘/ŶƚŚĞĞǀĞŶƚŽĨŝƐŽůĂƚĞĚE^ƉƌŽŐƌĞƐƐŝŽŶĚƵƌŝŶŐƐƚƵĚǇƚƌĞĂƚŵĞŶƚ͕ƌŽǀĂůƉŝƚƵǌƵŵĂď
ƚĞƐŝƌŝŶĞŵĂǇďĞǁŝƚŚŚĞůĚǁŚŝůĞĂƉĂůůŝĂƚŝǀĞƚƌĞĂƚŵĞŶƚŝƐĂĚŵŝŶŝƐƚĞƌĞĚ͘
DĂŶĂŐĞŵĞŶƚŽĨ^ƉĞĐŝĂůdŽǆŝĐŝƚǇŽŶĐĞƌŶƐ
^ĞƌŽƐĂůĞĨĨƵƐŝŽŶƐ;ƉůĞƵƌĂůŽƌƉĞƌŝĐĂƌĚŝĂůͿ͕ĂůŽŶĞŽƌŝŶĐŽŵďŝŶĂƚŝŽŶǁŝƚŚŐĞŶĞƌĂůŝǌĞĚŽƌƉĞƌŝƉŚĞƌĂůĞĚĞŵĂ
ĂŶĚͬŽƌŚǇƉŽĂůďƵŵŝŶĞŵŝĂ͕ŚĂǀĞďĞĞŶŽďƐĞƌǀĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘dŚĞƐĞĞǀĞŶƚƐŚĂǀĞƚŚĞ
ƉŽƚĞŶƚŝĂůƚŽďĞůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐ;Ğ͘Ő͕͘ƉĞƌŝĐĂƌĚŝĂůƚĂŵƉŽŶĂĚĞͿ͘ƐƉƌŽƉŚǇůĂǆŝƐ͕ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝƐ
ĂĚŵŝŶŝƐƚĞƌĞĚǁŝƚŚĚĞǆĂŵĞƚŚĂƐŽŶĞϴŵŐŽƌĂůůǇ/ŽŶĂǇʹϭ͕ĂǇϭ;ƚŚĞĚĂǇŽĨĚŽƐŝŶŐͿ͕ĂŶĚĂǇϮŽĨ
ĞĂĐŚƚƌĞĂƚŵĞŶƚĐǇĐůĞ͘
ĞǀĞůŽƉŵĞŶƚŽĨƐĞƌŽƐĂůĞĨĨƵƐŝŽŶĞǀĞŶƚƐŽƌǁŽƌƐĞŶŝŶŐĨƌŽŵďĂƐĞůŝŶĞǁĂƌƌĂŶƚƐƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶďǇƚŚĞ
/ŶǀĞƐƚŝŐĂƚŽƌŽƌĚĞƐŝŐŶĞĞ͘/ŶƚŚĞĞǀĞŶƚŽĨĂŐƌĂĚĞϮŽƌŚŝŐŚĞƌŝŶƚŚŝƐŐƌŽƵƉ;ĞĨĨƵƐŝŽŶƐ͕ĞĚĞŵĂ͕
ŚǇƉŽĂůďƵŵŝŶĞŵŝĂͿƚŚŽƵŐŚƚƚŽďĞƌĞůĂƚĞĚƚŽƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͕ĐŽŶƐŝĚĞƌĂĚŵŝŶŝƐƚƌĂƚŝŽŶŽĨƐǇƐƚĞŵŝĐ
ĐŽƌƚŝĐŽƐƚĞƌŽŝĚƐ͕Ğ͘Ő͕͘ĂƚĂƉĞƌĞĚƌĞŐŝŵĞŶŽĨĚĞǆĂŵĞƚŚĂƐŽŶĞ͘ůƚĞƌŶĂƚŝǀĞůǇ͕ŶŽŶƐƚĞƌŽŝĚĂůƚŚĞƌĂƉŝĞƐĨŽƌ
ƐĞƌŽƐŝƚŝƐŵĂǇďĞĐŽŶƐŝĚĞƌĞĚ͕ĂƐŽƵƚůŝŶĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
^ŬŝŶƚŽǆŝĐŝƚǇǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŵĂǇĐŽŶƐŝƐƚŽĨƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇĂƐǁĞůůĂƐŽƚŚĞƌƌĞĂĐƚŝŽŶƐ
;Ğ͘Ő͕͘ ƉĂůŵĂƌͲƉůĂŶƚĂƌĞƌǇƚŚƌŽĚǇƐĞƐƚŚĞƐŝĂ͕ĞƌǇƚŚĞŵĂŵƵůƚŝĨŽƌŵĞͿ͘ĞǀĞůŽƉŵĞŶƚŽĨĂĐƵƚĂŶĞŽƵƐƌĞĂĐƚŝŽŶ
ĚƵƌŝŶŐƚƌĞĂƚŵĞŶƚǁĂƌƌĂŶƚƐƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶďǇƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŽƌĚĞƐŝŐŶĞĞ͘&ŽƌƐŬŝŶƌĞĂĐƚŝŽŶƐ͕ƌĞĨĞƌ
ƚŽƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘ůůĞǀĞŶƚƐŽĨĐƵƚĂŶĞŽƵƐƚŽǆŝĐŝƚǇƐŚŽƵůĚďĞŵŽŶŝƚŽƌĞĚƵŶƚŝů
ƌĞƐŽůƵƚŝŽŶŽƌƌĞƚƵƌŶƚŽďĂƐĞůŝŶĞ͘
WŽƚĞŶƚŝĂůĚƌƵŐͲŝŶĚƵĐĞĚůŝǀĞƌŝŶũƵƌŝĞƐ;/>/ƐͿĂƌĞĚĞĨŝŶĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕ĂůŽŶŐǁŝƚŚ
ƌĞĐŽŵŵĞŶĚĂƚŝŽŶƐĨŽƌŵĂŶĂŐĞŵĞŶƚ͘ůůŽĐĐƵƌƌĞŶĐĞƐŽĨƉŽƚĞŶƚŝĂů/>/ƐŵĞĞƚŝŶŐƚŚĞĚĞĨŝŶĞĚĐƌŝƚĞƌŝĂŵƵƐƚ
ďĞƌĞƉŽƌƚĞĚĂƐ^Ɛ͘
WĂŐĞϮϬŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϲ͘ϯ dĂƐĞĞĨŝŶŝƚŝŽŶͬ'ƵŝĚĂŶĐĞ
dŽĨƵƌƚŚĞƌĂŝĚŝŶƉƌŽƐƉĞĐƚŝǀĞůǇŝĚĞŶƚŝĨǇŝŶŐƚƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚĂĚǀĞƌƐĞĞǀĞŶƚƐ;dƐͿ͕ƌĞĨĞƌƚŽƚŚĞ
ŐĞŶĞƌĂůƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐĐŽŝŶĐŝĚŝŶŐŽƌƉƌĞĐĞĚŝŶŐĞĂĐŚdĂƐůŝƐƚĞĚďĞůŽǁ͘
^ĞƌŽƐĂůĨĨƵƐŝŽŶƐ
^ĞƌŽƐĂůĞĨĨƵƐŝŽŶƐŚĂǀĞďĞĞŶŽďƐĞƌǀĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƚƌĞĂƚŵĞŶƚ͕ŵĂŝŶůǇƉůĞƵƌĂůĂŶĚ
ƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶƐ͘WŽƐƐŝďůĞƌŝƐŬŵŝƚŝŐĂƚŝŽŶŽĨƐĞƌŽƐĂůĞĨĨƵƐŝŽŶƐŝŶĐůƵĚĞƐĂĚŵŝŶŝƐƚƌĂƚŝŽŶŽĨ
ĚĞǆĂŵĞƚŚĂƐŽŶĞŽƌĂůůǇĂƚϴŵŐ/ŐŝǀĞŶŽŶĂǇʹϭ͕ĂǇϭ;ƚŚĞĚĂǇŽĨĚŽƐŝŶŐͿĂŶĚĂǇϮŽƌĞĂĐŚĐǇĐůĞ͘
WůĞƵƌĂůĂŶĚƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶƐĂƌĞĐŽŶƐŝĚĞƌĞĚƐĞƉĂƌĂƚĞŝŵƉŽƌƚĂŶƚŝĚĞŶƚŝĨŝĞĚƌŝƐŬƐĨŽƌƌŽǀĂůƉŝƚƵǌƵŵĂď
ƚĞƐŝƌŝŶĞ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƐĞƌŽƐĂůĞĨĨƵƐŝŽŶŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
WůĞƵƌĂůĨĨƵƐŝŽŶƐ
/ŶŐĞŶĞƌĂů͕ƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐĐŽŝŶĐŝĚŝŶŐǁŝƚŚŽƌƉƌĞĐĞĚŝŶŐƉůĞƵƌĂůĞĨĨƵƐŝŽŶƐŵĂǇŝŶĐůƵĚĞƐŚŽƌƚŶĞƐƐŽĨ
ďƌĞĂƚŚ͕ĐŚĞƐƚƚŝŐŚƚŶĞƐƐŽƌƉĂŝŶ͕ĐŽƵŐŚ͕ĂŶĚͬŽƌǁĞŝŐŚƚŐĂŝŶ͘DŽŶŝƚŽƌŝŶŐĨŽƌƐǇŵƉƚŽŵƐŽĨƉůĞƵƌĂů
ĞĨĨƵƐŝŽŶƐ͕ǁŚŝĐŚŝŶĐůƵĚĞǁŽƌƐĞŶŝŶŐĚǇƐƉŶĞĂ͕ĐŚĞƐƚƚŝŐŚƚŶĞƐƐŽƌƉĂŝŶ͕ŽƌǁŽƌƐĞŶŝŶŐĐŽƵŐŚ͕ƐŚŽƵůĚŽĐĐƵƌ
ƚŚƌŽƵŐŚŽƵƚƚŚĞƚƌĞĂƚŵĞŶƚĂŶĚƉŽƐƚͲƚƌĞĂƚŵĞŶƚƉĞƌŝŽĚ͘
/ĨƉůĞƵƌĂůĞĨĨƵƐŝŽŶŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇĂŶĚŝŵĂŐŝŶŐƐƚƵĚŝĞƐƐŚŽƵůĚŽĐĐƵƌƉĞƌŝŶƐƚŝƚƵƚŝŽŶĂů
ŐƵŝĚĞůŝŶĞƐ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƉůĞƵƌĂůĞĨĨƵƐŝŽŶŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
WĞƌŝĐĂƌĚŝĂůĨĨƵƐŝŽŶƐ
/ŶŐĞŶĞƌĂů͕ƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐĐŽŝŶĐŝĚŝŶŐǁŝƚŚŽƌƉƌĞĐĞĚŝŶŐĞǀĞŶƚƐŽĨƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶŵĂǇŝŶĐůƵĚĞ
ƐŚŽƌƚŶĞƐƐŽĨďƌĞĂƚŚ͕ĐŚĞƐƚƚŝŐŚƚŶĞƐƐŽƌƉĂŝŶ͕ĐŽƵŐŚ͕ĂŶĚͬŽƌǁĞŝŐŚƚŐĂŝŶ͘DŽƐƚƉĂƚŝĞŶƚƐǁŝƚŚƉĞƌŝĐĂƌĚŝĂů
ĞĨĨƵƐŝŽŶƐƌĞƉŽƌƚĞĚƉƌĞĐĞĚŝŶŐŽƌĐŽŶĐƵƌƌĞŶƚĞǀĞŶƚƐŽĨƉůĞƵƌĂůĞĨĨƵƐŝŽŶƐ͘DŽŶŝƚŽƌŝŶŐĨŽƌƐǇŵƉƚŽŵƐŽĨ
ƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶƐ͕ǁŚŝĐŚŝŶĐůƵĚĞǁŽƌƐĞŶŝŶŐĚǇƐƉŶĞĂ͕ĐŚĞƐƚƚŝŐŚƚŶĞƐƐŽƌƉĂŝŶ͕ǁŽƌƐĞŶŝŶŐĐŽƵŐŚ͕
ƐǇŶĐŽƉĞ͕ŽƌƉĂůƉŝƚĂƚŝŽŶƐƐŚŽƵůĚŽĐĐƵƌƚŚƌŽƵŐŚŽƵƚƚŚĞƚƌĞĂƚŵĞŶƚĂŶĚƉŽƐƚͲƚƌĞĂƚŵĞŶƚƉĞƌŝŽĚ͘/Ĩ
ƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇĂŶĚŝŵĂŐŝŶŐƐƚƵĚŝĞƐŝŶĐůƵĚŝŶŐĞĐŚŽĐĂƌĚŝŽŐƌĂƉŚǇ
ƐŚŽƵůĚŽĐĐƵƌƉĞƌŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐ͘WĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶƐĐĂŶƌĞƐƵůƚŝŶĐĂƌĚŝĂĐƚĂŵƉŽŶĂĚĞĂŶĚĐĂŶ
ďĞůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶƐŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
'ĞŶĞƌĂůŝǌĞĚĚĞŵĂ
'ĞŶĞƌĂůŝǌĞĚĞĚĞŵĂ;ĂŶĂƐĂƌĐĂͿŝƐĐŽŶƐŝĚĞƌĞĚĂŶŝŵƉŽƌƚĂŶƚŝĚĞŶƚŝĨŝĞĚƌŝƐŬĨŽƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘/Ŷ
ŐĞŶĞƌĂů͕ƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐĐŽŝŶĐŝĚŝŶŐǁŝƚŚŽƌƉƌĞĐĞĚŝŶŐŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂŵĂǇŝŶĐůƵĚĞŐĞŶĞƌĂůŝǌĞĚ
ƐǁĞůůŝŶŐŝŶĐůƵĚŝŶŐĞǆƚƌĞŵŝƚŝĞƐŽƌƉƵĨĨŝŶĞƐƐŽĨƚŚĞ ƐŬŝŶ͕ŝŶĐƌĞĂƐĞĚĂďĚŽŵĞŶƐŝǌĞ͕ĂŶĚĚǇƐƉŶĞĂ͘
'ĞŶĞƌĂůŝǌĞĚĞĚĞŵĂĞǀĞŶƚƐĂƌĞŝŶĨƌĞƋƵĞŶƚďƵƚŚĂǀĞƌĞƐƵůƚĞĚŝŶĨĂƚĂůŽƵƚĐŽŵĞƐĂŶĚĂƌĞŽĨƚĞŶƉƌĞĐĞĚĞĚďǇ
ĞǀĞŶƚƐŽĨƉĞƌŝƉŚĞƌĂůĞĚĞŵĂ͘'ĞŶĞƌĂůŝǌĞĚĞĚĞŵĂĐĂŶƉƌĞƐĞŶƚĂƐƵŶĞǆƉůĂŝŶĞĚǁĞŝŐŚƚŐĂŝŶ͕ƚŚƵƐŵŽŶŝƚŽƌ
ĨŽƌƐŝŐŶƐ ĂŶĚƐǇŵƉƚŽŵƐŽĨĨůƵŝĚƌĞƚĞŶƚŝŽŶ;ƵƐŝŶŐƚŚĞ&ůƵŝĚZĞƚĞŶƚŝŽŶYƵĞƐƚŝŽŶŶĂŝƌĞ΀ƉƉĞŶĚŝǆŽĨƚŚĞ
KƉĞƌĂƚŝŽŶƐDĂŶƵĂů΁Ϳ͘dŚĞĚĞǀĞůŽƉŵĞŶƚŽĨŶĞǁŽƌǁŽƌƐĞŶŝŶŐĞĚĞŵĂƐŚŽƵůĚƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶĨŽƌ
WĂŐĞϮϭŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ĂƐƐŽĐŝĂƚĞĚƐĞƌŽƐĂůĞĨĨƵƐŝŽŶƐ͘^ŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐŽĨŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂ ƐŚŽƵůĚďĞŵŽŶŝƚŽƌĞĚ
ƚŚƌŽƵŐŚŽƵƚƚƌĞĂƚŵĞŶƚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĂŶĚĂƐƉĂƌƚŽĨƚŚĞĨŽůůŽǁƵƉƉĞƌŝŽĚ͘
/ĨŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇĂŶĚŝŵĂŐŝŶŐŝŶǀĞƐƚŝŐĂƚŝŽŶƐŚŽƵůĚŽĐĐƵƌ͘/Ĩ
ŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂŝƐĐŽŶĨŝƌŵĞĚ͕ƉƌŽŵƉƚŝŶƚĞƌǀĞŶƚŝŽŶĂŶĚƚƌĞĂƚŵĞŶƚŝƐǁĂƌƌĂŶƚĞĚ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐĞĚĞŵĂŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
WĞƌŝƉŚĞƌĂůĚĞŵĂ
WĞƌŝƉŚĞƌĂůĞĚĞŵĂĐĂŶƉƌĞƐĞŶƚĂƐƐǁĞůůŝŶŐŽƌƉƵĨĨŝŶĞƐƐŽĨƚŚĞƐŬŝŶĂĨĨĞĐƚŝŶŐƚŚĞůĞŐƐ͕ĨĞĞƚ͕ĂŶĚĂŶŬůĞƐ͕ďƵƚ
ŝƚĐĂŶĂůƐŽŝŶǀŽůǀĞƚŚĞĂƌŵƐĂŶĚĨĂĐĞ͘WĞƌŝƉŚĞƌĂůĞĚĞŵĂĐĂŶƉƌĞƐĞŶƚĂƐƵŶĞǆƉůĂŝŶĞĚǁĞŝŐŚƚŐĂŝŶ͕ĂŶĚ
ƚŚƵƐŝƚŝƐŝŵƉŽƌƚĂŶƚƚŽŵŽŶŝƚŽƌĨŽƌƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐŽĨĨůƵŝĚƌĞƚĞŶƚŝŽŶ;ƵƐŝŶŐƚŚĞ&ůƵŝĚZĞƚĞŶƚŝŽŶ
YƵĞƐƚŝŽŶŶĂŝƌĞ΀ƉƉĞŶĚŝǆŽĨƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů΁Ϳ͘ZĞŐƵůĂƌƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶƐƐŚŽƵůĚďĞ
ĐŽŶĚƵĐƚĞĚĚƵƌŝŶŐƚƌĞĂƚŵĞŶƚ͕ĂŶĚƚŚĞĚĞǀĞůŽƉŵĞŶƚŽĨŶĞǁŽƌǁŽƌƐĞŶŝŶŐĞĚĞŵĂƐŚŽƵůĚƉƌŽŵƉƚ
ĞǀĂůƵĂƚŝŽŶĨŽƌĂƐƐŽĐŝĂƚĞĚƐĞƌŽƐĂůĞĨĨƵƐŝŽŶƐŽƌŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂ͘
/ĨƉĞƌŝƉŚĞƌĂůĞĚĞŵĂŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇĂŶĚŝŵĂŐŝŶŐŝŶǀĞƐƚŝŐĂƚŝŽŶƐŚŽƵůĚŽĐĐƵƌƉĞƌ
ŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐ͘/ĨƉĞƌŝƉŚĞƌĂůĞĚĞŵĂŝƐĐŽŶĨŝƌŵĞĚ͕ƉůĞĂƐĞƌĞĨĞƌƚŽƚŽǆŝĐŝƚǇŵĂŶĂŐĞŵĞŶƚƐĞĐƚŝŽŶ
ŽĨƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰĨŽƌĚŽƐĞƌĞĚƵĐƚŝŽŶŝŶƐƚƌƵĐƚŝŽŶƐ͘
ƵƚĂŶĞŽƵƐZĞĂĐƚŝŽŶƐ
^ŬŝŶƌĞĂĐƚŝŽŶƐŚĂǀĞďĞĞŶƌĞƉŽƌƚĞĚŝŶĂůŵŽƐƚŚĂůĨŽĨƚŚĞƐƵďũĞĐƚƐƚƌĞĂƚĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘
DŽƐƚƐŬŝŶƌĞĂĐƚŝŽŶƐĐŽŶƐŝƐƚŽĨƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇƌĞĂĐƚŝŽŶƐ͕ƌĂƐŚ͕ĂŶĚĞƌǇƚŚĞŵĂĂŶĚŵĂŝŶůǇŽĐĐƵƌŝŶ
ƐƵŶͲĞǆƉŽƐĞĚƌĞŐŝŽŶƐůŝŬĞƚŚĞĨĂĐĞĂŶĚĂƌŵƐ͘DŽƐƚĐƵƚĂŶĞŽƵƐƌĞĂĐƚŝŽŶƐĂƌĞчŐƌĂĚĞϮĂŶĚĚŽŶŽƚƌĞƋƵŝƌĞ
ŝŶƚĞƌǀĞŶƚŝŽŶ͘/ĨŶŽƚĐůŝŶŝĐĂůůǇĐŽŶƐŝƐƚĞŶƚǁŝƚŚƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ͕ƚŚĞĐƵƚĂŶĞŽƵƐƌĞĂĐƚŝŽŶƐŚŽƵůĚďĞ
ĞǀĂůƵĂƚĞĚďǇĂĚĞƌŵĂƚŽůŽŐŝƐƚ͕ŝŶĐůƵĚŝŶŐĐŽŶƐŝĚĞƌĂƚŝŽŶĨŽƌƐŬŝŶďŝŽƉƐǇƚŽĐŚĂƌĂĐƚĞƌŝǌĞƚŚĞƌĞĂĐƚŝŽŶĂŶĚ
ŐƵŝĚĞƐƵďƐĞƋƵĞŶƚƚƌĞĂƚŵĞŶƚĂŶĚͬŽƌĚŝƐƉŽƐŝƚŝŽŶŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĚŽƐŝŶŐ͘ĞǀĞůŽƉŵĞŶƚŽĨĂ
ĐƵƚĂŶĞŽƵƐƌĞĂĐƚŝŽŶĚƵƌŝŶŐƚƌĞĂƚŵĞŶƚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞǁĂƌƌĂŶƚƐƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐĐƵƚĂŶĞŽƵƐƐŬŝŶŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
WŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ
WŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇƌĞĂĐƚŝŽŶƐĂƌĞĂŶŝŵƉŽƌƚĂŶƚŝĚĞŶƚŝĨŝĞĚƌŝƐŬĨŽƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘WŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ
ŝƐĐŚĂƌĂĐƚĞƌŝǌĞĚďǇĂŶŝŶĐƌĞĂƐĞŝŶƐĞŶƐŝƚŝǀŝƚǇŽĨƚŚĞƐŬŝŶƚŽƐƵŶůŝŐŚƚ͘DŝŶŝŵŝǌĂƚŝŽŶŵĞĂƐƵƌĞƐĂŶĚ
ŵĂŶĂŐĞŵĞŶƚŽĨƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇĂƌĞŝŶĐůƵĚĞĚƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘ZŽǀĂůƉŝƚƵǌƵŵĂď
ƚĞƐŝƌŝŶĞĂƐƐŽĐŝĂƚĞĚƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇĐĂƵƐĞƐƌĞĚŶĞƐƐ;ĞƌǇƚŚĞŵĂͿĂŶĚƐƵŶďƵƌŶͲůŝŬĞĂƉƉĞĂƌĂŶĐĞŽĨƚŚĞƐŬŝŶ͘
dǇƉŝĐĂůůŽĐĂƚŝŽŶƐŝŶĐůƵĚĞĨĂĐĞ͕ǀͲƐŚĂƉĞĚĂƌĞĂŽĨƚŚĞŶĞĐŬ͕ĚŽƌƐĂůĂƌŵƐĂŶĚůĞŐƐ͘dŝŵĞƚŽŽŶƐĞƚŽĨ
ƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇǀĂƌŝĞƐǁŝĚĞůǇĂŶĚŵĂǇŽĐĐƵƌŚŽƵƌƐƚŽĚĂǇƐĂĨƚĞƌƐƵŶĞǆƉŽƐƵƌĞ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
dŚƌŽŵďŽĐǇƚŽƉĞŶŝĂǁŝƚŚůĞĞĚŝŶŐǀĞŶƚƐ
dŚƌŽŵďŽĐǇƚŽƉĞŶŝĂŚĂƐďĞĞŶŽďƐĞƌǀĞĚ ǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘dŚĞŵĂũŽƌŝƚǇŽĨƚŚƌŽŵďŽĐǇƚŽƉĞŶŝĂ
ĂŶĚƉůĂƚĞůĞƚĐŽƵŶƚĚĞĐƌĞĂƐĞŽďƐĞƌǀĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŚĂǀĞďĞĞŶчŐƌĂĚĞϯ͕ĂƌĞ
ĂƐǇŵƉƚŽŵĂƚŝĐ͕ĂŶĚŶŽƚĂƐƐŽĐŝĂƚĞĚǁŝƚŚĂŶŝŶĐƌĞĂƐĞĚƌŝƐŬŽĨďůĞĞĚŝŶŐ͘/ŶŐĞŶĞƌĂů͕ƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐ
WĂŐĞϮϮŽĨϳϬ


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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ĐŽŝŶĐŝĚŝŶŐǁŝƚŚŽƌƉƌĞĐĞĚŝŶŐƚŚƌŽŵďŽĐǇƚŽƉĞŶŝĂǁŝƚŚďůĞĞĚŝŶŐŵĂǇŝŶĐůƵĚĞďůŽŽĚŝŶƵƌŝŶĞŽƌďŽǁĞů
ŵŽǀĞŵĞŶƚ͕ŚĞĂĚĂĐŚĞƐ͕ŚĞĂǀǇŵĞŶƐƚƌƵĂůƉĞƌŝŽĚƐ͕ŽƌŶĞǁŽƌǁŽƌƐĞŶŝŶŐďƌƵŝƐŝŶŐ͘
/ĨƚŚƌŽŵďŽĐǇƚŽƉĞŶŝĂŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇŵŽŶŝƚŽƌŝŶŐƉĞƌŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐŵĂǇďĞ
ŶĞĐĞƐƐĂƌǇ͘
ĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƚŚƌŽŵďŽĐǇƚŽƉĞŶŝĂŵĂŶĂŐĞŵĞŶƚĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘ϰ͘
WŶĞƵŵŽŶŝƚŝƐ
WŶĞƵŵŽŶŝƚŝƐŚĂƐďĞĞŶŝŶĨƌĞƋƵĞŶƚůǇƌĞƉŽƌƚĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞďƵƚŚĂƐƌĞƐƵůƚĞĚŝŶĨĂƚĂů
ŽƵƚĐŽŵĞƐ͘/ŶŐĞŶĞƌĂůƐŝŐŶƐĂŶĚƐǇŵƉƚŽŵƐĐŽŝŶĐŝĚŝŶŐǁŝƚŚŽƌƉƌĞĐĞĚŝŶŐƉŶĞƵŵŽŶŝƚŝƐŵĂǇŝŶĐůƵĚĞŶĞǁŽƌ
ǁŽƌƐĞŶŝŶŐĐŽƵŐŚ͕ĐŚĞƐƚƉĂŝŶĂŶĚͬŽƌƐŚŽƌƚŶĞƐƐŽĨďƌĞĂƚŚ͕ĨĞǀĞƌ͕ĂŶĚƌĂĚŝŽŐƌĂƉŚŝĐĐŚĂŶŐĞƐ;ŐƌŽƵŶĚŐůĂƐƐ
ŽƉĂĐŝƚŝĞƐͿ͘/ĨƉŶĞƵŵŽŶŝƚŝƐŝƐƐƵƐƉĞĐƚĞĚ͕ĂĚĚŝƚŝŽŶĂůůĂďŽƌĂƚŽƌǇĂŶĚ ŝŵĂŐŝŶŐŝŶǀĞƐƚŝŐĂƚŝŽŶƉĞƌŝŶƐƚŝƚƵƚŝŽŶĂů
ŐƵŝĚĞůŝŶĞƐŵĂǇďĞŶĞĐĞƐƐĂƌǇ͘
ϲ͘ϰ WƌŽĚƵĐƚŽŵƉůĂŝŶƚƐ
ƉƌŽĚƵĐƚĐŽŵƉůĂŝŶƚŝƐĂŶǇĐŽŵƉůĂŝŶƚƌĞůĂƚĞĚƚŽƚŚĞďŝŽůŽŐŝĐŽƌĚƌƵŐĐŽŵƉŽŶĞŶƚŽĨƚŚĞƉƌŽĚƵĐƚŽƌƚŽƚŚĞ
ŵĞĚŝĐĂůĚĞǀŝĐĞĐŽŵƉŽŶĞŶƚ;ƐͿ͘
&ŽƌĂƉƌŽĚƵĐƚƚŚŝƐŵĂǇŝŶĐůƵĚĞ͕ďƵƚŝƐŶŽƚůŝŵŝƚĞĚƚŽ͕ĚĂŵĂŐĞĚͬďƌŽŬĞŶƉƌŽĚƵĐƚŽƌƉĂĐŬĂŐŝŶŐ͕ƉƌŽĚƵĐƚ
ĂƉƉĞĂƌĂŶĐĞǁŚŽƐĞĐŽůŽƌͬŵĂƌŬŝŶŐƐĚŽŶŽƚŵĂƚĐŚƚŚĞůĂďĞůŝŶŐ͕ůĂďĞůŝŶŐĚŝƐĐƌĞƉĂŶĐŝĞƐͬŝŶĂĚĞƋƵĂĐŝĞƐŝŶƚŚĞ
ůĂďĞůŝŶŐͬŝŶƐƚƌƵĐƚŝŽŶƐ;Ğ͘Ő͕͘ƉƌŝŶƚŝŶŐŝůůĞŐŝďůĞͿ͕ŵŝƐƐŝŶŐĐŽŵƉŽŶĞŶƚƐͬƉƌŽĚƵĐƚ͕ĚĞǀŝĐĞŶŽƚ ǁŽƌŬŝŶŐƉƌŽƉĞƌůǇ͕
ŽƌƉĂĐŬĂŐŝŶŐŝƐƐƵĞƐ͘
WƌŽĚƵĐƚĐŽŵƉůĂŝŶƚƐĐŽŶĐĞƌŶŝŶŐƚŚĞŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚĂŶĚͬŽƌĚĞǀŝĐĞŵƵƐƚďĞƌĞƉŽƌƚĞĚƚŽďďsŝĞ
ǁŝƚŚŝŶϭďƵƐŝŶĞƐƐĚĂǇŽĨƚŚĞƐƚƵĚǇƐŝƚĞΖƐŬŶŽǁůĞĚŐĞŽĨƚŚĞĞǀĞŶƚ͘WƌŽĚƵĐƚĐŽŵƉůĂŝŶƚƐŽĐĐƵƌƌŝŶŐĚƵƌŝŶŐ
ƚŚĞƐƚƵĚǇǁŝůů ďĞĨŽůůŽǁĞĚƵƉƚŽĂƐĂƚŝƐĨĂĐƚŽƌǇĐŽŶĐůƵƐŝŽŶ͘
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ϳ͘ϭ ^ƚĂƚŝƐƚŝĐĂůĂŶĚŶĂůǇƚŝĐĂůWůĂŶƐ
ƐƚŚŝƐŝƐĂŶĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͕ŶŽ^ƚĂƚŝƐƚŝĐĂůŶĂůǇƐŝƐWůĂŶ;^WͿǁŝůůďĞǁƌŝƚƚĞŶ͖ŽŶůǇĚĂƚĂĂŶĚůŝƐƚŝŶŐƐǁŝůů
ďĞƉƌŽĚƵĐĞĚĨŽƌ ĨƵƚƵƌĞƵƐĞ͘EŽŝŶƚĞƌŝŵĂŶĂůǇƐŝƐǁŝůůďĞƉůĂŶŶĞĚĂŶĚƉĞƌĨŽƌŵĞĚ͘
ϳ͘Ϯ ĞĨŝŶŝƚŝŽŶĨŽƌŶĂůǇƐŝƐWŽƉƵůĂƚŝŽŶƐ
KŶĞĂŶĂůǇƐŝƐƐĞƚǁŝůůďĞƵƐĞĚĨŽƌƚŚĞůŽŶŐͲƚĞƌŵ͕ƌŽůůŽǀĞƌĞǆƚĞŶƐŝŽŶƐƚƵĚǇƚŚĂƚǁŝůůŝŶĐůƵĚĞƐƵďũĞĐƚƐǁŚŽ
ƐŝŐŶĞĚĂŶŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚĂŶĚŵĞƚĂůůƚŚĞĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝĂ͕ƵŶůĞƐƐƐƉĞĐŝĨŝĞĚŽƚŚĞƌǁŝƐĞ͘
ϳ͘ϯ ŝƐƉŽƐŝƚŝŽŶŽĨ^ƚƵĚǇ^ƵďũĞĐƚƐ
dŚĞƐƵďũĞĐƚĚŝƐƉŽƐŝƚŝŽŶǁŝůůďĞƉƌĞƐĞŶƚĞĚŝŶůŝƐƚŝŶŐƐďǇƐƵďũĞĐƚ͘^ƵďũĞĐƚĚŝƐƉŽƐŝƚŝŽŶůŝƐƚŝŶŐƐǁŝůůŝŶĐůƵĚĞ
ƚŚĞĨŽůůŽǁŝŶŐ͗
WĂŐĞϮϯŽĨϳϬ


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^ƵďũĞĐƚƐǁŚŽ
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ĞŶƌŽůůĞĚ
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ƉƌĞŵĂƚƵƌĞůǇĚŝƐĐŽŶƚŝŶƵĞĚĨƌŽŵƚŚĞƐƚƵĚǇ;ŝŶĐůƵĚŝŶŐƚŚĞƌĞĂƐŽŶƐĨŽƌĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨ
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dŚĞŶƵŵďĞƌŽĨƐƵďũĞĐƚƐǁŚŽƌĞĐĞŝǀĞĚĂƚůĞĂƐƚϭĚŽƐĞŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ
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ƐƵďũĞĐƚƐǁŚŽƉƌĞŵĂƚƵƌĞůǇĚŝƐĐŽŶƚŝŶƵĞĚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ;ŝŶĐůƵĚŝŶŐƚŚĞƌĞĂƐŽŶƐĨŽƌ
ƚƌĞĂƚŵĞŶƚĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶͿ
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^ƵďũĞĐƚĚĞĂƚŚƐ
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ĚĞĂƚŚĚƵĞƚŽĂŶǇĐĂƵƐĞĚƵƌŝŶŐƚŚĞƐƚƵĚǇ
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ƉƌŝŵĂƌǇƌĞĂƐŽŶĨŽƌĚĞĂƚŚǁŝůůĂůƐŽďĞƐƵŵŵĂƌŝǌĞĚ
ϳ͘ϰ ^ƚĂƚŝƐƚŝĐĂůŶĂůǇƐĞƐĨŽƌĨĨŝĐĂĐǇ
EŽĞĨĨŝĐĂĐǇĂŶĂůǇƐĞƐǁŝůůďĞƉĞƌĨŽƌŵĞĚ͘>ŝƐƚŝŶŐƐĨŽƌĚŝƐĞĂƐĞ ĂŶĚƌĞƐƉŽŶƐĞĂƐƐĞƐƐŵĞŶƚ͕ŝŶĐůƵĚŝŶŐƚƵŵŽƌ
ŝŵĂŐŝŶŐĂŶĚďƌĂŝŶŵĂŐŶĞƚŝĐƌĞƐŽŶĂŶĐĞŝŵĂŐŝŶŐ;DZ/Ϳ͕ǁŝůůďĞƉƌŽǀŝĚĞĚĨŽƌƐƵďũĞĐƚƐŝŶ^ƚƵĚǇƌŵƐ
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ϳ͘ϱ ^ƚĂƚŝƐƚŝĐĂůŶĂůǇƐĞƐĨŽƌ^ĂĨĞƚǇ
ĚǀĞƌƐĞĞǀĞŶƚƐǁŝůůďĞĐŽĚĞĚĂŶĚƐƵŵŵĂƌŝǌĞĚďǇƐǇƐƚĞŵŽƌŐĂŶĐůĂƐƐĂŶĚƉƌĞĨĞƌƌĞĚƚĞƌŵ;ĂŶĚƐĞǀĞƌŝƚǇͿ
ĂĐĐŽƌĚŝŶŐƚŽƚŚĞDĞĚŝĐĂůŝĐƚŝŽŶĂƌǇĨŽƌZĞŐƵůĂƚŽƌǇĐƚŝǀŝƚŝĞƐ;DĞĚZͿǀĞƌƐŝŽŶϮϬ͘ϭŽƌŚŝŐŚĞƌ͘ůŝŶŝĐĂů
ƚŽǆŝĐŝƚǇŐƌĂĚĞƐŵŽĚŝĨŝĞĚĨƌŽŵƚŚĞE/dǀĞƌƐŝŽŶϰ͘ϬǁŝůůďĞƵƐĞĚŝŶƚŚĞŐƌĂĚŝŶŐŽĨƐĂŶĚ
ůĂďŽƌĂƚŽƌǇĂďŶŽƌŵĂůŝƚŝĞƐƚŚĂƚĂƌĞ ƌĞƉŽƌƚĞĚĂƐƐ͘
EŽƐĂĨĞƚǇĂŶĂůǇƐĞƐǁŝůůďĞƉĞƌĨŽƌŵĞĚ͘ůŝƐƚŝŶŐŽĨĚĂƚĂĨŽƌƐƵďũĞĐƚƐĞǆƉĞƌŝĞŶĐŝŶŐƐǁŝůůďĞƉƌŽǀŝĚĞĚ͘
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ůĂƐƚ ĚŽƐĞĂŶĚ^ƐƌĞůĂƚĞĚƚŽƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĨƌŽŵϳϭĚĂǇƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞƵŶƚŝůƚŚĞ
ĞŶĚŽĨƐƚƵĚǇǁŝůůďĞƐƵŵŵĂƌŝǌĞĚ͘
ĞĨŝŶŝƚŝŽŶƐŽĨƐĂƌĞƉƌŽǀŝĚĞĚŝŶ^ĞĐƚŝŽŶϲ͘ϭ ĂŶĚƚŚĞKƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϰ͘
WĂŐĞϮϰŽĨϳϬ


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ϳ͘ϲ ĞƚĞƌŵŝŶĂƚŝŽŶŽĨ^ĂŵƉůĞ^ŝǌĞ
dŚĞƌĞŝƐŶŽŵŝŶŝŵƵŵŽƌŵĂǆŝŵƵŵƐĂŵƉůĞƐŝǌĞĨŽƌƚŚŝƐƐƚƵĚǇǁŚŝĐŚĚĞƉĞŶĚƐŽŶƚŚĞŶƵŵďĞƌŽĨƐƵďũĞĐƚƐ
ǁŚŽǁŝůůĞŶƌŽůůŝŶƚŽƚŚĞĞǆƚĞŶƐŝŽŶƐƚƵĚǇƵƉŽŶĐŽŵƉůĞƚŝŽŶŽĨƉƌŝŵĂƌǇĂŶĂůǇƐŝƐŽĨƚŚĞƉĂƌĞŶƚ
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ƐƵďŵŝƚƚĞĚƚŽƚŚĞ/ͬ/ZĨŽƌƌĞǀŝĞǁĂŶĚĂƉƉƌŽǀĂů͘ƉƉƌŽǀĂůŽĨďŽƚŚƚŚĞƉƌŽƚŽĐŽůĂŶĚƚŚĞŝŶĨŽƌŵĞĚ
ĐŽŶƐĞŶƚĨŽƌŵ;ƐͿŵƵƐƚďĞŽďƚĂŝŶĞĚďĞĨŽƌĞĂŶǇƉĂƌƚŝĐŝƉĂŶƚŝƐĞŶƌŽůůĞĚ͘ŶǇĂŵĞŶĚŵĞŶƚƚŽƚŚĞƉƌŽƚŽĐŽů
ǁŝůůƌĞƋƵŝƌĞƌĞǀŝĞǁĂŶĚĂƉƉƌŽǀĂůďǇƚŚĞ/ͬ/ZďĞĨŽƌĞƚŚĞĐŚĂŶŐĞƐĂƌĞŝŵƉůĞŵĞŶƚĞĚƚŽƚŚĞƐƚƵĚǇ͘/Ŷ
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ϴ͘Ϯ ƚŚŝĐĂůŽŶĚƵĐƚŽĨƚŚĞ^ƚƵĚǇ
dŚĞƐƚƵĚǇǁŝůůďĞĐŽŶĚƵĐƚĞĚŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚƚŚĞƉƌŽƚŽĐŽů͕KƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕/ŶƚĞƌŶĂƚŝŽŶĂůŽƵŶĐŝů
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ĐŽŶĚƵĐƚĂŶĚƚŚĞĞƚŚŝĐĂůƉƌŝŶĐŝƉůĞƐƚŚĂƚŚĂǀĞƚŚĞŝƌŽƌŝŐŝŶŝŶƚŚĞĞĐůĂƌĂƚŝŽŶŽĨ,ĞůƐŝŶŬŝ͘ZĞƐƉŽŶƐŝďŝůŝƚŝĞƐŽĨ
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ϴ͘ϯ ^ƵďũĞĐƚŽŶĨŝĚĞŶƚŝĂůŝƚǇ
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KDW>d/KE
dŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŝƐƌĞƐƉŽŶƐŝďůĞĨŽƌĞŶƐƵƌŝŶŐƚŚĞĂĐĐƵƌĂĐǇ͕ĐŽŵƉůĞƚĞŶĞƐƐ͕ůĞŐŝďŝůŝƚǇ͕ĂŶĚƚŝŵĞůŝŶĞƐƐŽĨƚŚĞ
ĚĂƚĂƌĞƉŽƌƚĞĚ͘ůůƐŽƵƌĐĞĚŽĐƵŵĞŶƚƐƐŚŽƵůĚďĞĂƚƚƌŝďƵƚĂďůĞ͕ůĞŐŝďůĞ͕ĐŽŶƚĞŵƉŽƌĂŶĞŽƵƐ͕ŽƌŝŐŝŶĂů͕
ĂĐĐƵƌĂƚĞ͕ĂŶĚĐŽŵƉůĞƚĞƚŽĞŶƐƵƌĞĂĐĐƵƌĂƚĞŝŶƚĞƌƉƌĞƚĂƚŝŽŶŽĨĚĂƚĂ͘ůŝŶŝĐĂůƐŝƚĞŵŽŶŝƚŽƌŝŶŐŝƐĐŽŶĚƵĐƚĞĚ
ƚŽĞŶƐƵƌĞƚŚĂƚƚŚĞƌŝŐŚƚƐĂŶĚǁĞůůͲďĞŝŶŐŽĨŚƵŵĂŶƐƵďũĞĐƚƐĂƌĞƉƌŽƚĞĐƚĞĚ͕ƚŚĂƚƚŚĞƌĞƉŽƌƚĞĚƚƌŝĂůĚĂƚĂ
ĂƌĞĂĐĐƵƌĂƚĞ͕ĐŽŵƉůĞƚĞ͕ĂŶĚǀĞƌŝĨŝĂďůĞ͕ĂŶĚƚŚĂƚƚŚĞĐŽŶĚƵĐƚŽĨƚŚĞƚƌŝĂůŝƐŝŶĐŽŵƉůŝĂŶĐĞǁŝƚŚƚŚĞ
ĐƵƌƌĞŶƚůǇĂƉƉƌŽǀĞĚƉƌŽƚŽĐŽů͕/,'ŽŽĚůŝŶŝĐĂůWƌĂĐƚŝĐĞ;'WͿ͕ĂŶĚĂƉƉůŝĐĂďůĞůŽĐĂůƌĞŐƵůĂƚŽƌǇ
ƌĞƋƵŝƌĞŵĞŶƚ;ƐͿ͘
WĂŐĞϮϱŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϭϬ dYh>/dz^^hZE
ďďsŝĞǁŝůůĞŶƐƵƌĞƚŚĂƚƚŚĞĐůŝŶŝĐĂůƚƌŝĂůŝƐĐŽŶĚƵĐƚĞĚĂŶĚĚĂƚĂĂƌĞŐĞŶĞƌĂƚĞĚ͕ĚŽĐƵŵĞŶƚĞĚĂŶĚƌĞƉŽƌƚĞĚ
ŝŶĐŽŵƉůŝĂŶĐĞǁŝƚŚƚŚĞƉƌŽƚŽĐŽů͕/,'W͕ĂŶĚĂƉƉůŝĐĂďůĞƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͘
ϭϭ KDW>d/KEK&d,^dhz
ŽŵƉůĞƚŝŽŶŽĨƚŚĞƐƚƵĚǇŝŶďŽƚŚĂƌŵƐǁŝůůďĞǁŚĞŶƐƵďũĞĐƚƐĞǆƉĞƌŝĞŶĐĞĚĞĂƚŚŽƌĚŝƐĐŽŶƚŝŶƵĞƚŚĞƐƚƵĚǇ
ĨŽƌŽƚŚĞƌƌĞĂƐŽŶƐ
ϭϮ Z&ZE^
ϭ͘
ďďsŝĞ͘ZŽǀĂůƉŝƚƵǌƵŵĂďdĞƐŝƌŝŶĞ;^ϭϲ>ϲ͘ϱͿ/ŶǀĞƐƚŝŐĂƚŽƌΖƐƌŽĐŚƵƌĞĚŝƚŝŽŶϳ͘Ϭ͘ϮϬϭϴ͘
Ϯ͘
ŝƐĞŶŚĂƵĞƌ͕dŚĞƌĂƐƐĞW͕ŽŐĂĞƌƚƐ:͕ĞƚĂů͘EĞǁƌĞƐƉŽŶƐĞĞǀĂůƵĂƚŝŽŶĐƌŝƚĞƌŝĂŝŶƐŽůŝĚƚƵŵŽƵƌƐ͗
ZĞǀŝƐĞĚZ/^dŐƵŝĚĞůŝŶĞ;ǀĞƌƐŝŽŶϭ͘ϭͿ͘Ƶƌ:ĂŶĐĞƌ͘ϮϬϬϵ͖ϰϱ;ϮͿ͗ϮϮϴͲϰϳ͘
ϯ͘
>ĞǀĞǇ^͕ŽƌĞƐŚ:͕'ƌĞĞŶd͕ĞƚĂů͘hƐŝŶŐƐƚĂŶĚĂƌĚŝǌĞĚƐĞƌƵŵĐƌĞĂƚŝŶŝŶĞǀĂůƵĞƐŝŶƚŚĞ
ŵŽĚŝĨŝĐĂƚŝŽŶŽĨĚŝĞƚŝŶƌĞŶĂůĚŝƐĞĂƐĞƐƚƵĚǇĞƋƵĂƚŝŽŶĨŽƌĞƐƚŝŵĂƚŝŶŐŐůŽŵĞƌƵůĂƌĨŝůƚƌĂƚŝŽŶƌĂƚĞ͘
ŶŶ/ŶƚĞƌŶDĞĚ͘ϮϬϬϲ͖ϭϰϱ;ϰͿ͗ϮϰϳͲϱ͘
WĂŐĞϮϲŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX A. STUDY SPECIFIC ABBREVIATIONS AND TERMS
ďďƌĞǀŝĂƚŝŽŶ
ĞĨŝŶŝƚŝŽŶ

ĂŶƚŝďŽĚǇͲĚƌƵŐĐŽŶũƵŐĂƚĞ

ĂĚǀĞƌƐĞĞǀĞŶƚ
>d
ĂůĂŶŝŶĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ
^d
ĂƐƉĂƌƚĂƚĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ
E
ĂďƐŽůƵƚĞŶĞƵƚƌŽƉŚŝůĐŽƵŶƚ
/
ƚǁŝĐĞĚĂŝůǇ
E^
ĐĞŶƚƌĂůŶĞƌǀŽƵƐƐǇƐƚĞŵ
d
ŽŵŵŽŶdĞƌŵŝŶŽůŽŐǇƌŝƚĞƌŝĂĨŽƌĚǀĞƌƐĞǀĞŶƚƐ
/>/
ĚƌƵŐͲŝŶĚƵĐĞĚůŝǀĞƌŝŶũƵƌǇ
>>ϯ
ĚĞůƚĂͲůŝŬĞƉƌŽƚĞŝŶϯ
K'
ĂƐƚĞƌŶŽŽƉĞƌĂƚŝǀĞKŶĐŽůŽŐǇ'ƌŽƵƉ
ĞZ&
ĞůĞĐƚƌŽŶŝĐĂƐĞZĞƉŽƌƚ&Žƌŵ
;ĞͿ'&Z
;ĞƐƚŝŵĂƚĞĚͿŐůŽŵĞƌƵůĂƌĨŝůƚƌĂƚŝŽŶƌĂƚĞ
&^,
ĨŽůůŝĐůĞͲƐƚŝŵƵůĂƚŝŶŐŚŽƌŵŽŶĞ
'W
'ŽŽĚůŝŶŝĐĂůWƌĂĐƚŝĐĞ
/,
/ŶƚĞƌŶĂƚŝŽŶĂůŽƵŶĐŝůĨŽƌ,ĂƌŵŽŶŝƐĂƚŝŽŶ
/
/ŶĚĞƉĞŶĚĞŶƚƚŚŝĐƐŽŵŵŝƚƚĞĞ
/DW
/ŶǀĞƐƚŝŐĂƚŝŽŶĂůDĞĚŝĐŝŶĂůWƌŽĚƵĐƚ
/Z
/ŶǀĞƐƚŝŐĂƚŝŽŶĂůZĞǀŝĞǁŽĂƌĚ
/Zd
/ŶƚĞƌĂĐƚŝǀĞZĞƐƉŽŶƐĞdĞĐŚŶŽůŽŐǇ
/s
ŝŶƚƌĂǀĞŶŽƵƐͬŝŶƚƌĂǀĞŶŽƵƐůǇ
DĞĚZ
DĞĚŝĐĂůŝĐƚŝŽŶĂƌǇĨŽƌZĞŐƵůĂƚŽƌǇĐƚŝǀŝƚŝĞƐ
DZ/
ŵĂŐŶĞƚŝĐƌĞƐŽŶĂŶĐĞŝŵĂŐŝŶŐ
E/
EĂƚŝŽŶĂůĂŶĐĞƌ/ŶƐƚŝƚƵƚĞ
Wd&h
WƌĞŵĂƚƵƌĞdĞƌŵŝŶĂƚŝŽŶ&ŽůůŽǁhƉ
Z/^d
ZĞƐƉŽŶƐĞǀĂůƵĂƚŝŽŶƌŝƚĞƌŝĂĨŽƌ^ŽůŝĚdƵŵŽƌƐ
^
ƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚ
^W
^ƚĂƚŝƐƚŝĐĂůŶĂůǇƐŝƐWůĂŶ
^>
ƐŵĂůůĐĞůůůƵŶŐĐĂƌĐŝŶŽŵĂ
^h^Z
^ƵƐƉĞĐƚĞĚhŶĞǆƉĞĐƚĞĚ^ĞƌŝŽƵƐĚǀĞƌƐĞZĞĂĐƚŝŽŶƐ
WĂŐĞϮϳŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
d
ƚƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚĂĚǀĞƌƐĞĞǀĞŶƚ
h>E
hƉƉĞƌ>ŝŵŝƚŽĨEŽƌŵĂů
WĂŐĞϮϴŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX B. RESPONSIBILITIES OF THE INVESTIGATOR
WƌŽƚŽĐŽůDϭϲͲϮϵϭ͗ZŽǀĂůƉŝƚƵǌƵŵĂďdĞƐŝƌŝŶĞ;ZŽǀĂͲdͿǆƚĞŶƐŝŽŶ^ƚƵĚǇ
WƌŽƚŽĐŽůĂƚĞ͗ϮϬ DĂǇϮϬϭϵ
ůŝŶŝĐĂůƌĞƐĞĂƌĐŚƐƚƵĚŝĞƐƐƉŽŶƐŽƌĞĚďǇďďsŝĞĂƌĞƐƵďũĞĐƚƚŽƚŚĞ/ŶƚĞƌŶĂƚŝŽŶĂůŽƵŶĐŝůĨŽƌ,ĂƌŵŽŶŝƐĂƚŝŽŶ
;/,Ϳ'ŽŽĚůŝŶŝĐĂůWƌĂĐƚŝĐĞƐ;'WͿĂŶĚůŽĐĂůƌĞŐƵůĂƚŝŽŶƐĂŶĚŐƵŝĚĞůŝŶĞƐŐŽǀĞƌŶŝŶŐƚŚĞƐƚƵĚǇĂƚƚŚĞƐŝƚĞ
ůŽĐĂƚŝŽŶ͘/ŶƐŝŐŶŝŶŐƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŐƌĞĞŵĞŶƚ͕ƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌŝƐĂŐƌĞĞŝŶŐƚŽƚŚĞĨŽůůŽǁŝŶŐ͗
ϭ͘
ŽŶĚƵĐƚŝŶŐƚŚĞƐƚƵĚǇŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚ/,'W͕ƚŚĞĂƉƉůŝĐĂďůĞƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͕
ĐƵƌƌĞŶƚƉƌŽƚŽĐŽůĂŶĚŽƉĞƌĂƚŝŽŶƐŵĂŶƵĂů͕ĂŶĚŵĂŬŝŶŐĐŚĂŶŐĞƐƚŽĂƉƌŽƚŽĐŽůŽŶůǇĂĨƚĞƌŶŽƚŝĨǇŝŶŐ
ďďsŝĞĂŶĚƚŚĞĂƉƉƌŽƉƌŝĂƚĞ/ŶƐƚŝƚƵƚŝŽŶĂůZĞǀŝĞǁŽĂƌĚ;/ZͿͬ/ŶĚĞƉĞŶĚĞŶƚƚŚŝĐƐŽŵŵŝƚƚĞĞ
;/Ϳ͕ĞǆĐĞƉƚǁŚĞŶŶĞĐĞƐƐĂƌǇƚŽƉƌŽƚĞĐƚƚŚĞƐƵďũĞĐƚĨƌŽŵŝŵŵĞĚŝĂƚĞŚĂƌŵ͘
Ϯ͘
WĞƌƐŽŶĂůůǇĐŽŶĚƵĐƚŝŶŐŽƌƐƵƉĞƌǀŝƐŝŶŐƚŚĞĚĞƐĐƌŝďĞĚŝŶǀĞƐƚŝŐĂƚŝŽŶ;ƐͿ͘
ϯ͘
/ŶĨŽƌŵŝŶŐĂůůƐƵďũĞĐƚƐ͕ŽƌƉĞƌƐŽŶƐƵƐĞĚĂƐĐŽŶƚƌŽůƐ͕ƚŚĂƚƚŚĞĚƌƵŐƐĂƌĞďĞŝŶŐƵƐĞĚĨŽƌ
ŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƵƌƉŽƐĞƐĂŶĚĐŽŵƉůǇŝŶŐǁŝƚŚƚŚĞƌĞƋƵŝƌĞŵĞŶƚƐƌĞůĂƚŝŶŐƚŽŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚĂŶĚ
ĞƚŚŝĐƐĐŽŵŵŝƚƚĞĞƐ;Ğ͘Ő͕͘/Žƌ/ZͿƌĞǀŝĞǁĂŶĚĂƉƉƌŽǀĂůŽĨƚŚĞƉƌŽƚŽĐŽůĂŶĚŝƚƐĂŵĞŶĚŵĞŶƚƐ͘
ϰ͘
ZĞƉŽƌƚŝŶŐĐŽŵƉůĂŝŶƚƐƚŚĂƚ ŽĐĐƵƌŝŶƚŚĞĐŽƵƌƐĞŽĨƚŚĞŝŶǀĞƐƚŝŐĂƚŝŽŶ;ƐͿƚŽďďsŝĞ͘
ϱ͘
ZĞĂĚŝŶŐƚŚĞŝŶĨŽƌŵĂƚŝŽŶŝŶƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌΖƐƌŽĐŚƵƌĞͬƐĂĨĞƚǇŵĂƚĞƌŝĂůƉƌŽǀŝĚĞĚ͕ŝŶĐůƵĚŝŶŐƚŚĞ
ŝŶƐƚƌƵĐƚŝŽŶƐĨŽƌƵƐĞĂŶĚƚŚĞƉŽƚĞŶƚŝĂůƌŝƐŬƐĂŶĚƐŝĚĞĞĨĨĞĐƚƐŽĨƚŚĞŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚ;ƐͿ͘
ϲ͘
/ŶĨŽƌŵŝŶŐĂůůĂƐƐŽĐŝĂƚĞƐ͕ĐŽůůĞĂŐƵĞƐ͕ĂŶĚĞŵƉůŽǇĞĞƐĂƐƐŝƐƚŝŶŐŝŶƚŚĞĐŽŶĚƵĐƚŽĨƚŚĞƐƚƵĚǇĂďŽƵƚ
ƚŚĞŝƌŽďůŝŐĂƚŝŽŶƐŝŶŵĞĞƚŝŶŐƚŚĞĂďŽǀĞĐŽŵŵŝƚŵĞŶƚƐ͘
ϳ͘
DĂŝŶƚĂŝŶŝŶŐĂĚĞƋƵĂƚĞĂŶĚĂĐĐƵƌĂƚĞƌĞĐŽƌĚƐŽĨƚŚĞĐŽŶĚƵĐƚŽĨƚŚĞƐƚƵĚǇ͕ŵĂŬŝŶŐƚŚŽƐĞƌĞĐŽƌĚƐ
ĂǀĂŝůĂďůĞĨŽƌŝŶƐƉĞĐƚŝŽŶ ďǇƌĞƉƌĞƐĞŶƚĂƚŝǀĞƐŽĨďďsŝĞĂŶĚͬŽƌƚŚĞĂƉƉƌŽƉƌŝĂƚĞƌĞŐƵůĂƚŽƌǇĂŐĞŶĐǇ͕
ĂŶĚƌĞƚĂŝŶŝŶŐĂůůƐƚƵĚǇͲƌĞůĂƚĞĚĚŽĐƵŵĞŶƚƐƵŶƚŝůŶŽƚŝĨŝĐĂƚŝŽŶĨƌŽŵďďsŝĞ͘
ϴ͘
DĂŝŶƚĂŝŶŝŶŐƌĞĐŽƌĚƐĚĞŵŽŶƐƚƌĂƚŝŶŐƚŚĂƚĂŶĞƚŚŝĐƐĐŽŵŵŝƚƚĞĞƌĞǀŝĞǁĞĚĂŶĚĂƉƉƌŽǀĞĚƚŚĞŝŶŝƚŝĂů
ĐůŝŶŝĐĂůƉƌŽƚŽĐŽů ĂŶĚĂůůŽĨŝƚƐĂŵĞŶĚŵĞŶƚƐ͘
ϵ͘
ZĞƉŽƌƚŝŶŐƉƌŽŵƉƚůǇ͕ĂůůĐŚĂŶŐĞƐŝŶƚŚĞƌĞƐĞĂƌĐŚĂĐƚŝǀŝƚǇĂŶĚĂůůƵŶĂŶƚŝĐŝƉĂƚĞĚƉƌŽďůĞŵƐŝŶǀŽůǀŝŶŐ
ƌŝƐŬƐƚŽŚƵŵĂŶƐƵďũĞĐƚƐŽƌŽƚŚĞƌƐ͕ƚŽƚŚĞĂƉƉƌŽƉƌŝĂƚĞŝŶĚŝǀŝĚƵĂůƐ;Ğ͘Ő͕͘ĐŽŽƌĚŝŶĂƚŝŶŐŝŶǀĞƐƚŝŐĂƚŽƌ͕
ŝŶƐƚŝƚƵƚŝŽŶĚŝƌĞĐƚŽƌͿĂŶĚͬŽƌĚŝƌĞĐƚůǇƚŽƚŚĞĞƚŚŝĐƐĐŽŵŵŝƚƚĞĞƐĂŶĚďďsŝĞ͘
ϭϬ͘ WƌŽǀŝĚŝŶŐĚŝƌĞĐƚĂĐĐĞƐƐƚŽƐŽƵƌĐĞĚĂƚĂĚŽĐƵŵĞŶƚƐĨŽƌƐƚƵĚǇͲƌĞůĂƚĞĚŵŽŶŝƚŽƌŝŶŐ͕ĂƵĚŝƚƐ͕/ͬ/Z
ƌĞǀŝĞǁ͕ĂŶĚƌĞŐƵůĂƚŽƌǇŝŶƐƉĞĐƚŝŽŶ;ƐͿ͘
^ŝŐŶĂƚƵƌĞŽĨWƌŝŶĐŝƉĂů/ŶǀĞƐƚŝŐĂƚŽƌ
ĂƚĞ
EĂŵĞŽĨWƌŝŶĐŝƉĂů/ŶǀĞƐƚŝŐĂƚŽƌ;ƉƌŝŶƚĞĚŽƌƚǇƉĞĚͿ
WĂŐĞϮϵŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
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APPENDIX C. LIST OF PROTOCOL SIGNATORIES
Name
Title
Functional Area
ůŝŶŝĐĂůWƌŽŐƌĂŵĞǀĞůŽƉŵĞŶƚ
ůŝŶŝĐĂůWƌŽŐƌĂŵĞǀĞůŽƉŵĞŶƚ
ůŝŶŝĐĂůWƌŽŐƌĂŵĞǀĞůŽƉŵĞŶƚ
ĂƚĂĂŶĚ^ƚĂƚŝƐƚŝĐĂů^ĐŝĞŶĐĞƐ
DĞĚŝĐĂůtƌŝƚŝŶŐ
WĂŐĞϯϬŽĨϳϬ












^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX E. PROTOCOL SUMMARY OF CHANGES
Previous Protocol Versions
Protocol 
Date
sĞƌƐŝŽŶϭ͘Ϭ
ϮϭDĂƌĐŚ ϮϬϭϴ
sĞƌƐŝŽŶϮ͘Ϭ
Ϯϵ:ƵŶĞϮϬϭϴ
sĞƌƐŝŽŶϯ͘Ϭ
ϭϭKĐƚŽďĞƌϮϬϭϴ
dŚĞƉƵƌƉŽƐĞŽĨƚŚŝƐsĞƌƐŝŽŶŝƐƚŽŵĂŬĞƚŚĞĨŽůůŽǁŝŶŐ ĐŚĂŶŐĞƐ͗
•
ĚĚĞĚƉĂƌĂŐƌĂƉŚƐƚĂƚŝŶŐƚŚĂƚƐŽŵĞƐƵďũĞĐƚƐŵĂǇŶŽƚďĞŶĞĨŝƚĨƌŽŵZŽǀĂͲdƚƌĞĂƚŵĞŶƚ
;^ĞĐƚŝŽŶ Ϯ͘Ϯ͕ĞŶĞĨŝƚƐĂŶĚZŝƐŬƐƚŽ^ƵďũĞĐƚƐͿ
•
hƉĚĂƚĞĚ ŶƵŵďĞƌŽĨƐŝƚĞƐĂŶĚůŝƐƚŽĨĐŽƵŶƚƌŝĞƐŝŶǀŽůǀĞĚŝŶƚŚĞƐƚƵĚǇ͕ĂĚĚĞĚ^ƚƵĚŝĞƐ^ZyϬϬϭͲϬϬϲ
ĂŶĚDϭϲͲϮϴϵ ƚŽůŝƐƚŽĨƉĂƌĞŶƚƐƚƵĚŝĞƐĞůŝŐŝďůĞĨŽƌƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ;^ĞĐƚŝŽŶϰ͘ϭ͕KǀĞƌĂůů^ƚƵĚǇ
ĞƐŝŐŶĂŶĚWůĂŶͿ
•
hƉĚĂƚĞĚĞůŝŐŝďŝůŝƚǇĐƌŝƚĞƌŝĂƚŽĂůůŽǁĞŶƌŽůůŵĞŶƚŽĨƐƵďũĞĐƚƐǁŚŽĚŽŶŽƚŚĂǀĞĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶ
ďƵƚĂƌĞƌĞĐĞŝǀŝŶŐďĞŶĞĨŝƚĨƌŽŵƐƚƵĚǇƚƌĞĂƚŵĞŶƚ͖ĂĚĚĞĚŝŶƐƚƌƵĐƚŝŽŶƚŚĂƚƉƌŝŽƌƚŽƉƌŽǀŝĚŝŶŐ
ƌĞƚƌĞĂƚŵĞŶƚƚŽƐƵďũĞĐƚƐ͕ŝŶǀĞƐƚŝŐĂƚŽƌƐƐŚŽƵůĚĐŽŶƐƵůƚǁŝƚŚƚŚĞďďsŝĞDĞĚŝĐĂůDŽŶŝƚŽƌ
;^ĞĐƚŝŽŶ ϱ͘ϭ͕ůŝŐŝďŝůŝƚǇƌŝƚĞƌŝĂͿ
•
ŽƌƌĞĐƚĞĚŵŝŶŽƌŝŶĐŽŶƐŝƐƚĞŶĐŝĞƐŝŶƐƚƵĚǇĨŽůůŽǁͲƵƉǁŝŶĚŽǁ;ƉƉĞŶĚŝǆ͕ĐƚŝǀŝƚǇ ^ĐŚĞĚƵůĞ͖
KƉĞƌĂƚŝŽŶƐDĂŶƵĂů͕^ĞĐƚŝŽŶϮ͘ϭĂŶĚ^ĞĐƚŝŽŶϮ͘ϯͿ
WĂŐĞϯϲŽĨϳϬ


^dhzDϭϲͲϮϵϭͮsĞƌƐŝŽŶϰ͘ϬͬƵĚƌĂd ϮϬϭϴͲϬϬϬϵϬϯͲϭϴ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX F. OPERATIONS MANUAL
WĂŐĞϯϳŽĨϳϬ




Ɖ͘Ϯ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϭ KEdd^
^ƉŽŶƐŽƌͬ
ŵĞƌŐĞŶĐǇŽŶƚĂĐƚ
ďďsŝĞ/ŶĐ͘
KŶĐŽůŽŐǇůŝŶŝĐĂůĞǀĞůŽƉŵĞŶƚ
ϭEŽƌƚŚtĂƵŬĞŐĂŶZŽĂĚ
EŽƌƚŚŚŝĐĂŐŽ͕/>ϲϬϬϲϰ
EMERGENCY 24 hour Number:  
DŽďŝůĞ͗
KĨĨŝĐĞ͗
^ĂĨĞƚǇŽŶĐĞƌŶƐ
KŶĐŽůŽŐǇ^ĂĨĞƚǇdĞĂŵ
ďďsŝĞ
ϭEŽƌƚŚtĂƵŬĞŐĂŶZŽĂĚ
EŽƌƚŚŚŝĐĂŐŽ͕/>ϲϬϬϲϰ
WŚŽŶĞ͗
ŵĂŝů͗
^ZĞƉŽƌƚŝŶŐŽƵƚƐŝĚĞ
ŽĨZs
ŵĂŝů͗

&Ăǆ͗
WƌŽƚŽĐŽůĞǀŝĂƚŝŽŶƐ
^ƚƵĚǇWƌŽũĞĐƚDĂŶĂŐĞƌ
KZ
^ƚƵĚǇDĂŶĂŐĞŵĞŶƚƐƐŽĐŝĂƚĞ
WŚŽŶĞ;DŽďŝůĞͿ͗
ŵĂŝů͗
KZ
WŚŽŶĞ͗
ŵĂŝů
ĞƌƚŝĨŝĞĚůŝŶŝĐĂů
>ĂďŽƌĂƚŽƌǇ
Covance
Indianapolis
ϴϮϭϭ^ĐŝŽƌƌŝǀĞ
/ŶĚŝĂŶĂƉŽůŝƐ͕/EϰϲϮϭϰͲϮϵϴϱ
h^
WŚŽŶĞ͗ ;ϯϭϳͿϮϳϭϭϮϬϬ;ůŽĐĂůĐĂůůƐͿ
&Ăǆ͗
;ϯϭϳͿϮϳϯϰϬϯϬ
Geneva
ZƵĞDŽŢƐĞͲDĂƌĐŝŶŚĞƐϳ
,Ͳ ϭϮϭϳDĞǇƌŝŶͬ'ĞŶğǀĞ
^ǁŝƚǌĞƌůĂŶĚ
WŚŽŶĞ͗ нϰϭϱϴϴϮϮϳϵϬϭ
&Ăǆ͗
нϰϭϱϴϴϮϮϳϱϮϭ
WĂŐĞϯϵŽĨϳϬ


Ɖ͘ϯ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
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TABLE OF CONTENTS
1
CONTACTS
2
2
INVESTIGATION PLAN
5
2.1
ARM A (NO RETREATMENT) VISIT ACTIVITIES
5
2.2
ARM A RETREATMENT VISIT ACTIVITIES
6
2.3
ARM B ONGOING TREATMENT VISIT ACTIVITIES
7
3
STUDY PROCEDURES
12
3.1
SUBJECT INFORMATION AND INFORMED CONSENT
12
3.2
DEMOGRAPHICS
12
3.3
PHYSICAL EXAMINATION AND WEIGHT
12
3.4
VITAL SIGNS
13
3.5
ADVERSE EVENT ASSESSMENT
13
3.6
ECHOCARDIOGRAM
13
3.7
DISPENSE STUDY DRUG
13
3.8
CLINICAL LABORATORY TESTS
13
3.9
OTHER ASSESSMENTS
15
4
SAFETY MANUAL
16
4.1
METHODS AND TIMING OF SAFETY ASSESSMENT
16
4.2
RECORDING DATA AND ANALYSES OF SAFETY FINDINGS
17
4.3
REPORTING ADVERSE EVENTS AND INTERCURRENT ILLNESSES
18
4.4
TOXICITY MANAGEMENT
19
5
COUNTRY-SPECIFIC REQUIREMENTS
24
5.1
SAMPLE RETENTION REQUIREMENTS
24
5.2
SUSAR REPORTING
24
6
STUDY DRUG
24
6.1
TREATMENTS ADMINISTERED
24
6.2
PACKAGING AND LABELING
26
WĂŐĞϰϬŽĨϳϬ


Ɖ͘ϰ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
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6.3
METHOD OF ASSIGNING SUBJECTS TO STUDY ARMS
27
LIST OF TABLES
TABLE 1.
GUIDELINES FOR MANAGING HEMATOLOGIC TOXICITIES
20
TABLE 2.
RECOMMENDED MANAGEMENT OF PHOTOSENSITIVITY
22
TABLE 3.
INVESTIGATIONAL PRODUCTS:  ROVALPITUZUMAB TESIRINE
25
LIST OF APPENDICES
APPENDIX A.
STUDY SPECIFIC ABBREVIATIONS AND TERMS
28
APPENDIX B.
PERFORMANCE STATUS SCALES CONVERSION
30
APPENDIX C.
FLUID RETENTION QUESTIONNAIRE EXAMPLE
31
WĂŐĞϰϭŽĨϳϬ
















Ɖ͘ϭϮ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ϯ ^dhzWZKhZ^
ϯ͘ϭ ^ƵďũĞĐƚ/ŶĨŽƌŵĂƚŝŽŶĂŶĚ/ŶĨŽƌŵĞĚŽŶƐĞŶƚ
dŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŽƌŚŝƐͬŚĞƌƌĞƉƌĞƐĞŶƚĂƚŝǀĞǁŝůůĞǆƉůĂŝŶƚŚĞŶĂƚƵƌĞŽĨƚŚĞƐƚƵĚǇƚŽƚŚĞƐƵďũĞĐƚĂŶĚĂŶƐǁĞƌ
ĂůůƋƵĞƐƚŝŽŶƐƌĞŐĂƌĚŝŶŐƚŚŝƐƐƚƵĚǇ͘WƌŝŽƌƚŽĂŶǇƐƚƵĚǇͲƌĞůĂƚĞĚƐĐƌĞĞŶŝŶŐƉƌŽĐĞĚƵƌĞƐďĞŝŶŐƉĞƌĨŽƌŵĞĚŽŶ
ƚŚĞƐƵďũĞĐƚŽƌĂŶǇŵĞĚŝĐĂƚŝŽŶƐďĞŝŶŐĚŝƐĐŽŶƚŝŶƵĞĚďǇƚŚĞƐƵďũĞĐƚŝŶŽƌĚĞƌƚŽƉĂƌƚŝĐŝƉĂƚĞŝŶƚŚŝƐƐƚƵĚǇ͕
ƚŚĞŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚƐƚĂƚĞŵĞŶƚǁŝůůďĞƌĞǀŝĞǁĞĚ͕ƐŝŐŶĞĚ͕ĂŶĚĚĂƚĞĚďǇƚŚĞƐƵďũĞĐƚ͕ƚŚĞƉĞƌƐŽŶǁŚŽ
ĂĚŵŝŶŝƐƚĞƌĞĚƚŚĞŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚ͕ĂŶĚĂŶǇŽƚŚĞƌƐŝŐŶĂƚŽƌŝĞƐĂĐĐŽƌĚŝŶŐƚŽůŽĐĂůƌĞƋƵŝƌĞŵĞŶƚƐ͘ĐŽƉǇ
ŽĨƚŚĞƐŝŐŶĞĚŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚǁŝůůďĞŐŝǀĞŶƚŽƚŚĞƐƵďũĞĐƚĂŶĚƚŚĞŽƌŝŐŝŶĂůǁŝůůďĞƉůĂĐĞĚŝŶƚŚĞ
ƐƵďũĞĐƚΖƐŵĞĚŝĐĂůƌĞĐŽƌĚ͘ŶĞŶƚƌǇŵƵƐƚĂůƐŽďĞŵĂĚĞŝŶƚŚĞƐƵďũĞĐƚΖƐĚĂƚĞĚƐŽƵƌĐĞĚŽĐƵŵĞŶƚƐƚŽ
ĐŽŶĨŝƌŵƚŚĂƚŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚǁĂƐŽďƚĂŝŶĞĚƉƌŝŽƌƚŽĂŶǇƐƚƵĚǇͲƌĞůĂƚĞĚƉƌŽĐĞĚƵƌĞƐĂŶĚƚŚĂƚƚŚĞƐƵďũĞĐƚ
ƌĞĐĞŝǀĞĚĂƐŝŐŶĞĚĐŽƉǇ͘
/ŶĨŽƌŵĂƚŝŽŶƌĞŐĂƌĚŝŶŐďĞŶĞĨŝƚƐĨŽƌƐƵďũĞĐƚƐĂŶĚŝŶĨŽƌŵĂƚŝŽŶƌĞŐĂƌĚŝŶŐƉƌŽǀŝƐŝŽŶƐĨŽƌƚƌĞĂƚŝŶŐĂŶĚͬŽƌ
ĐŽŵƉĞŶƐĂƚŝŶŐƐƵďũĞĐƚƐǁŚŽĂƌĞŚĂƌŵĞĚĂƐĂĐŽŶƐĞƋƵĞŶĐĞŽĨƉĂƌƚŝĐŝƉĂƚŝŽŶŝŶƚŚĞƐƚƵĚǇĐĂŶďĞĨŽƵŶĚŝŶ
ƚŚĞŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚĨŽƌŵ͘
ϯ͘Ϯ ĞŵŽŐƌĂƉŚŝĐƐ
ĞŵŽŐƌĂƉŚŝĐƐǁŝůůďĞĐŽůůĞĐƚĞĚĂƚƐĐƌĞĞŶŝŶŐǀŝƐŝƚƐĂƐĚĞƐĐƌŝďĞĚŝŶ^ĞĐƚŝŽŶϮ ĂŶĚƉƌĞǀŝŽƵƐůǇĐŽůůĞĐƚĞĚ
ŝŶĨŽƌŵĂƚŝŽŶǁŝůůďĞƚƌĂŶƐĨĞƌƌĞĚĞůĞĐƚƌŽŶŝĐĂůůǇĚŝƌĞĐƚůǇĨƌŽŵƚŚĞƉĂƌĞŶƚƐƚƵĚǇΖƐůĞĐƚƌŽŶŝĐĂƚĂĂƉƚƵƌĞ
;ͿƐǇƐƚĞŵ͘
ϯ͘ϯ WŚǇƐŝĐĂůǆĂŵŝŶĂƚŝŽŶĂŶĚtĞŝŐŚƚ
ĐŽŵƉůĞƚĞƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶǁŝůůďĞƉĞƌĨŽƌŵĞĚĂƚƚŚĞĚĞƐŝŐŶĂƚĞĚƐƚƵĚǇǀŝƐŝƚƐĂƐƐƉĞĐŝĨŝĞĚŝŶ
^ĞĐƚŝŽŶ Ϯ͘ŶǇƐŝŐŶŝĨŝĐĂŶƚƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶĨŝŶĚŝŶŐƐĂĨƚĞƌƚŚĞĨŝƌƐƚĚŽƐĞǁŝůůďĞƌĞĐŽƌĚĞĚĂƐĂĚǀĞƌƐĞ
ĞǀĞŶƚƐ͘ůůĨŝŶĚŝŶŐƐ͕ǁŚĞƚŚĞƌƌĞůĂƚĞĚƚŽĂŶĂĚǀĞƌƐĞĞǀĞŶƚ;ͿŽƌƉĂƌƚŽĨĞĂĐŚƐƵďũĞĐƚΖƐŵĞĚŝĐĂůŚŝƐƚŽƌǇ͕
ǁŝůůďĞĐĂƉƚƵƌĞĚŽŶƚŚĞĂƉƉƌŽƉƌŝĂƚĞĞůĞĐƚƌŽŶŝĐĂƐĞZĞƉŽƌƚ&Žƌŵ;ĞZ&ͿƉĂŐĞ͘
,ĞŝŐŚƚǁŝůůďĞŵĞĂƐƵƌĞĚĂƚƐĐƌĞĞŶŝŶŐŽŶůǇ͕ŝĨĂƉƉůŝĐĂďůĞ͘ŽĚǇǁĞŝŐŚƚǁŝůůďĞŵĞĂƐƵƌĞĚĂƚƐĐŚĞĚƵůĞĚ
ǀŝƐŝƚƐĂƐƉĂƌƚŽĨƚŚĞƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶ͘dŚĞƐƵďũĞĐƚǁŝůůǁĞĂƌůŝŐŚƚǁĞŝŐŚƚĐůŽƚŚŝŶŐĂŶĚŶŽƐŚŽĞƐĚƵƌŝŶŐ
ǁĞŝŐŚŝŶŐ͘
ƚĂŶǇƚŝŵĞ͕ĂƐǇŵƉƚŽŵͲĚŝƌĞĐƚĞĚƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶĐĂŶďĞƉĞƌĨŽƌŵĞĚĂƐĚĞĞŵĞĚŶĞĐĞƐƐĂƌǇďǇƚŚĞ
/ŶǀĞƐƚŝŐĂƚŽƌ͘
WĂŐĞϰϵŽĨϳϬ


Ɖ͘ϭϯ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
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ϯ͘ϰ sŝƚĂů^ŝŐŶƐ
sŝƚĂůƐŝŐŶĚĞƚĞƌŵŝŶĂƚŝŽŶƐŽĨďŽĚǇƚĞŵƉĞƌĂƚƵƌĞ͕ƐǇƐƚŽůŝĐĂŶĚĚŝĂƐƚŽůŝĐďůŽŽĚƉƌĞƐƐƵƌĞ͕ƉƵůƐĞƌĂƚĞ͕ĂŶĚ
ƌĞƐƉŝƌĂƚŝŽŶƐǁŝůůďĞŽďƚĂŝŶĞĚĂƚǀŝƐŝƚƐĂƐƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ͘ůŽŽĚƉƌĞƐƐƵƌĞĂŶĚƉƵůƐĞƌĂƚĞƐŚŽƵůĚďĞ
ŵĞĂƐƵƌĞĚĂĨƚĞƌƚŚĞƐƵďũĞĐƚŚĂƐďĞĞŶƐŝƚƚŝŶŐĨŽƌĂƚůĞĂƐƚϯŵŝŶƵƚĞƐ͘
ϯ͘ϱ ĚǀĞƌƐĞǀĞŶƚƐƐĞƐƐŵĞŶƚ
ZĞĨĞƌƚŽ^ĞĐƚŝŽŶϰ͘Ϯ ĨŽƌĚĞƚĂŝůƐ͘
ϯ͘ϲ ĐŚŽĐĂƌĚŝŽŐƌĂŵ
ŶĞĐŚŽĐĂƌĚŝŽŐƌĂŵǁŝůůďĞƉĞƌĨŽƌŵĞĚĂƚƚŚĞĚĞƐŝŐŶĂƚĞĚƐƚƵĚǇǀŝƐŝƚƐĂƐƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ͘dŚĞ
ĞĐŚŽĐĂƌĚŝŽŐƌĂŵǁŝůůŝŶĐůƵĚĞĂƐƐĞƐƐŵĞŶƚƐŽĨůĞĨƚǀĞŶƚƌŝĐƵůĂƌĞũĞĐƚŝŽŶĨƌĂĐƚŝŽŶĂŶĚƉĞƌŝĐĂƌĚŝĂůĞĨĨƵƐŝŽŶ͘
ϯ͘ϳ ŝƐƉĞŶƐĞ^ƚƵĚǇƌƵŐ
^ƚƵĚǇĚƌƵŐ;ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞͿǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚŝŶƚƌĂǀĞŶŽƵƐůǇ;/sͿƚŽƐƵďũĞĐƚƐŽŶĂǇϭŽĨĞĂĐŚ
ƚƌĞĂƚŵĞŶƚĐǇĐůĞ͕ĂƐƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ͘dŚĞĨŝƌƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚĂĨƚĞƌĂůů
ŽƚŚĞƌĂǇϭƉƌŽĐĞĚƵƌĞƐĂƌĞĐŽŵƉůĞƚĞĚ͘ĞǆĂŵĞƚŚĂƐŽŶĞ;ŽƌĞƋƵŝǀĂůĞŶƚĐŽƌƚŝĐŽƐƚĞƌŽŝĚͿǁŝůůďĞ
ƐĞůĨͲĂĚŵŝŶŝƐƚĞƌĞĚƚǁŝĐĞĚĂŝůǇ;/ͿďǇƐƵďũĞĐƚƐŽŶĂǇʹϭ͕ĂǇϭ͕ĂŶĚĂǇϮŽĨĞĂĐŚƚƌĞĂƚŵĞŶƚĐǇĐůĞ͘
&ƵƌƚŚĞƌŝŶĨŽƌŵĂƚŝŽŶŽŶƐƚƵĚǇĚƌƵŐŝƐƉƌĞƐĞŶƚĞĚŝŶ^ĞĐƚŝŽŶϲ͘
ϯ͘ϴ ůŝŶŝĐĂů>ĂďŽƌĂƚŽƌǇdĞƐƚƐ
ŚĞŵŝƐƚƌǇ
dŚĞďůŽŽĚƐĂŵƉůĞƐĨŽƌƐĞƌƵŵĐŚĞŵŝƐƚƌǇƚĞƐƚƐƐŚŽƵůĚďĞĐŽůůĞĐƚĞĚƉƌŝŽƌƚŽƐƚƵĚǇĚƌƵŐĂĚŵŝŶŝƐƚƌĂƚŝŽŶ͘
dŚĞďĂƐĞůŝŶĞůĂďŽƌĂƚŽƌǇƚĞƐƚƌĞƐƵůƚƐĨŽƌĐůŝŶŝĐĂůĂƐƐĞƐƐŵĞŶƚĨŽƌĂƉĂƌƚŝĐƵůĂƌƚĞƐƚǁŝůůďĞĚĞĨŝŶĞĚĂƐƚŚĞůĂƐƚ
ŵĞĂƐƵƌĞŵĞŶƚƉƌŝŽƌƚŽƚŚĞŝŶŝƚŝĂůĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͘
>ŽĐĂůůĂďŽƌĂƚŽƌŝĞƐĐĂŶďĞƵƚŝůŝǌĞĚƚŽƉƌŽĐĞƐƐĂŶĚƉƌŽǀŝĚĞƌĞƐƵůƚƐĨŽƌƚŚĞĐůŝŶŝĐĂůůĂďŽƌĂƚŽƌǇƚĞƐƚƐ͕ĚŽƐŝŶŐ
ĐĂŶŽĐĐƵƌďĂƐĞĚŽŶƌĞƐƵůƚƐĨƌŽŵůŽĐĂůůĂďŽƌĂƚŽƌŝĞƐ͘>ĂďŽƌĂƚŽƌǇƌĞĨĞƌĞŶĐĞƌĂŶŐĞƐǁŝůůďĞŽďƚĂŝŶĞĚƉƌŝŽƌƚŽ
ƚŚĞŝŶŝƚŝĂƚŝŽŶŽĨƚŚĞƐƚƵĚǇ͘/ĨĂůĂďŽƌĂƚŽƌǇƚĞƐƚǀĂůƵĞŝƐŽƵƚƐŝĚĞƚŚĞƌĞĨĞƌĞŶĐĞƌĂŶŐĞĂŶĚƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌ
ĐŽŶƐŝĚĞƌƐƚŚĞůĂďŽƌĂƚŽƌǇƌĞƐƵůƚƚŽďĞĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚ͕ƚŚĞ ŝŶǀĞƐƚŝŐĂƚŽƌǁŝůů͗
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ƌĞƉĞĂƚƚŚĞƚĞƐƚƚŽǀĞƌŝĨǇƚŚĞŽƵƚͲŽĨͲƌĂŶŐĞǀĂůƵĞ͖
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ĨŽůůŽǁƚŚĞŽƵƚͲŽĨͲƌĂŶŐĞǀĂůƵĞƚŽĂƐĂƚŝƐĨĂĐƚŽƌǇĐůŝŶŝĐĂůƌĞƐŽůƵƚŝŽŶ͖Žƌ
WĂŐĞϱϬŽĨϳϬ


Ɖ͘ϭϰ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
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ĚŝƐĐŽŶƚŝŶƵĞƚŚĞƐƵďũĞĐƚĨƌŽŵƚŚĞƐƚƵĚǇŽƌƌĞƋƵŝƌĞƚŚĞƐƵďũĞĐƚƚŽƌĞĐĞŝǀĞƚƌĞĂƚŵĞŶƚ͖ŝŶƚŚŝƐĐĂƐĞ͕
ƚŚĞůĂďŽƌĂƚŽƌǇƌĞƐƵůƚǁŝůůďĞƌĞĐŽƌĚĞĚĂƐĂŶĂĚǀĞƌƐĞĞǀĞŶƚ͘
Clinical Laboratory Tests
Hematology
Clinical Chemistry
Other Tests
tŚŝƚĞďůŽŽĚĐĞůůĐŽƵŶƚǁŝƚŚ
ĨŝǀĞͲƉĂƌƚĚŝĨĨĞƌĞŶƚŝĂů͕ƚŽŝŶĐůƵĚĞ͗
EĞƵƚƌŽƉŚŝůƐ
>ǇŵƉŚŽĐǇƚĞƐ
DŽŶŽĐǇƚĞƐ
ĂƐŽƉŚŝůƐ
ŽƐŝŶŽƉŚŝůƐ
ZĞĚůŽŽĚ Ğůů;ZͿĐŽƵŶƚ
WůĂƚĞůĞƚĐŽƵŶƚ;ĞƐƚŝŵĂƚĞŶŽƚ
ĂĐĐĞƉƚĂďůĞͿ
,ĞŵĂƚŽĐƌŝƚ
,ĞŵŽŐůŽďŝŶ
^ŽĚŝƵŵ
WŽƚĂƐƐŝƵŵ
ŚůŽƌŝĚĞ
ĂƌďŽŶĚŝŽǆŝĚĞ
ƌĞĂƚŝŶŝŶĞ
ůŽŽĚhƌĞĂEŝƚƌŽŐĞŶ;hEͿ
ƐƚŝŵĂƚĞĚŐůŽŵĞƌƵůĂƌĨŝůƚƌĂƚŝŽŶƌĂƚĞ
'ůƵĐŽƐĞ
ůďƵŵŝŶ
dŽƚĂůƉƌŽƚĞŝŶ
>ŝǀĞƌĨƵŶĐƚŝŽŶƚĞƐƚƐ͕ƚŽŝŶĐůƵĚĞ͗
dŽƚĂůĂŶĚĚŝƌĞĐƚďŝůŝƌƵďŝŶ
ůĂŶŝŶĞƚƌĂŶƐĂŵŝŶĂƐĞ;>dͿ
ƐƉĂƌƚĂƚĞƚƌĂŶƐĂŵŝŶĂƐĞ;^dͿ
ůŬĂůŝŶĞƉŚŽƐƉŚĂƚĂƐĞ
>ĂĐƚĂƚĞĚĞŚǇĚƌŽŐĞŶĂƐĞ
ŵǇůĂƐĞ
>ŝƉĂƐĞ
ŽĂŐƵůĂƚŝŽŶƚĞƐƚƐƚŽŝŶĐůƵĚĞ͗
WƌŽƚŚƌŽŵďŝŶƚŝŵĞ;WdͿ
WĂƌƚŝĂůƚŚƌŽŵďŽƉůĂƐƚŝŶƚŝŵĞ;WddͿ
/ŶƚĞƌŶĂƚŝŽŶĂůŶŽƌŵĂůŝǌĞĚƌĂƚŝŽ;/EZͿ
Urinalysis
ŽůŽƌ
ƉƉĞĂƌĂŶĐĞ
^ƉĞĐŝĨŝĐŐƌĂǀŝƚǇ
Ɖ,
'ůƵĐŽƐĞ
ŝůŝƌƵďŝŶ
<ĞƚŽŶĞƐ
KĐĐƵůƚďůŽŽĚ
WƌŽƚĞŝŶ
^ƉŽƚƵƌŝŶĞƉƌŽƚĞŝŶ
ƌĞĂƚŝŶŝŶĞ
hƌŝŶĂůǇƐŝƐ
ŝƉƐƚŝĐŬƵƌŝŶĂůǇƐŝƐǁŝůůďĞĐŽŵƉůĞƚĞĚďǇƚŚĞĐĞŶƚƌĂůůĂďŽƌĂƚŽƌǇĂƚĂůůƌĞƋƵŝƌĞĚǀŝƐŝƚƐ͘^ƉĞĐŝĨŝĞĚĂďŶŽƌŵĂů
ŵĂĐƌŽƐĐŽƉŝĐƵƌŝŶĂůǇƐĞƐĚĞĨŝŶĞĚĂƐůĞƵŬŽĐǇƚĞƐ͕ŶŝƚƌŝƚĞ͕ƉƌŽƚĞŝŶ͕ŬĞƚŽŶĞƐ͕ŽƌďůŽŽĚŐƌĞĂƚĞƌƚŚĂŶŶĞŐĂƚŝǀĞ͕
ŽƌŐůƵĐŽƐĞŐƌĞĂƚĞƌƚŚĂŶŶŽƌŵĂůǁŝůůďĞĨŽůůŽǁĞĚƵƉǁŝƚŚĂŵŝĐƌŽƐĐŽƉŝĐĂŶĂůǇƐŝƐĂƚƚŚĞĐĞŶƚƌĂůůĂďŽƌĂƚŽƌǇ͘
WƌĞŐŶĂŶĐǇdĞƐƚƐ;hƌŝŶĞͿ
ƉƌĞŐŶĂŶƚŽƌďƌĞĂƐƚĨĞĞĚŝŶŐĨĞŵĂůĞǁŝůůŶŽƚďĞĞůŝŐŝďůĞĨŽƌƉĂƌƚŝĐŝƉĂƚŝŽŶŽƌĐŽŶƚŝŶƵĂƚŝŽŶŝŶƚŚŝƐƐƚƵĚǇ͘
ĞƚĞƌŵŝŶĂƚŝŽŶŽĨƉŽƐƚŵĞŶŽƉĂƵƐĂůƐƚĂƚƵƐǁŝůůďĞŵĂĚĞĚƵƌŝŶŐƚŚĞƐĐƌĞĞŶŝŶŐƉĞƌŝŽĚďĂƐĞĚŽŶƚŚĞ
ƐƵďũĞĐƚΖƐŚŝƐƚŽƌǇ͘
WĂŐĞϱϭŽĨϳϬ


Ɖ͘ϭϱ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ƋƵĂŶƚŝƚĂƚŝǀĞƵƌŝŶĞƉƌĞŐŶĂŶĐǇƚĞƐƚǁŝůůďĞƉĞƌĨŽƌŵĞĚŽŶƐŝƚĞŽƌďǇůŽĐĂůůĂďŽƌĂƚŽƌǇĂƐƐƉĞĐŝĨŝĞĚŝŶ
^ĞĐƚŝŽŶϮ ĨŽƌĂůůǁŽŵĞŶŽĨĐŚŝůĚͲďĞĂƌŝŶŐƉŽƚĞŶƚŝĂů͘/ĨƚŚĞƵƌŝŶĞƉƌĞŐŶĂŶĐǇƚĞƐƚŝƐŶĞŐĂƚŝǀĞ͕ďĞŐŝŶŽƌ
ĐŽŶƚŝŶƵĞĚŽƐŝŶŐ͘
ĚĚŝƚŝŽŶĂůƚĞƐƚŝŶŐŵĂǇďĞĚŽŶĞƉĞƌƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌ͘
ϯ͘ϵ KƚŚĞƌƐƐĞƐƐŵĞŶƚƐ
ůůĂƐƐĞƐƐŵĞŶƚƐƚĂŬĞƉůĂĐĞĂƐĚĞƐĐƌŝďĞĚŝŶ^ĞĐƚŝŽŶϮ͘
ĂƐƚĞƌŶŽŽƉĞƌĂƚŝǀĞKŶĐŽůŽŐǇ'ƌŽƵƉ;K'ͿƐĐĂůĞǁŝůůďĞƵƐĞĚƚŽĂƐƐĞƐƐƉĞƌĨŽƌŵĂŶĐĞƐƚĂƚƵƐĂƚƚŚĞ
^ĐƌĞĞŶŝŶŐǀŝƐŝƚƐŝŶƌŵƌĞƚƌĞĂƚŵĞŶƚĂŶĚƌŵ͘&ŽƌĐŽŶǀĞƌƐŝŽŶŽĨƉĞƌĨŽƌŵĂŶĐĞƐƚĂƚƵƐƵƐŝŶŐ<ĂƌŶŽĨƐŬǇ
ƐĐĂůĞƐƚŽK'͕ƐĞĞƉƉĞŶĚŝǆ͘
DZ/ŽĨƚŚĞďƌĂŝŶ;ŝĨĐůŝŶŝĐĂůůǇŝŶĚŝĐĂƚĞĚͿƐŚŽƵůĚďĞƉĞƌĨŽƌŵĞĚƚŽĐŽŶĨŝƌŵĂďƐĞŶĐĞŽĨĂĐƚŝǀĞĐĞŶƚƌĂů
ŶĞƌǀŽƵƐƐǇƐƚĞŵ;E^ͿƚƵŵŽƌŽƌŵĞƚĂƐƚĂƐĞƐ͘ƌĂŝŶDZ/ŵĂǇďĞƐƵďƐƚŝƚƵƚĞĚďǇĐŽŵƉƵƚĞƌŝǌĞĚƚŽŵŽŐƌĂƉŚǇ
;dͿǁŝƚŚ/sĐŽŶƚƌĂƐƚĂƚƚŚĞĚŝƐĐƌĞƚŝŽŶŽĨƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌŝĨDZ/ƚĞƐƚŝŶŐŝƐĐůŝŶŝĐĂůůǇĐŽŶƚƌĂŝŶĚŝĐĂƚĞĚ͕ŶŽƚ
ĂǀĂŝůĂďůĞ͕ŽƌŝĨƚŚĞƐƵďũĞĐƚŝƐƵŶĂďůĞƚŽƚŽůĞƌĂƚĞDZ/͘DZ/ĂƐƐĞƐƐŵĞŶƚƐǁŝůůďĞƉĞƌĨŽƌŵĞĚĂƚƐƚƵĚǇǀŝƐŝƚƐ
ĂƐƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ͘
dŝŵĂŐŝŶŐŽĨƚŚĞĐŚĞƐƚ͕ĂďĚŽŵĞŶ͕ĂŶĚƉĞůǀŝƐ͕ĂŶĚŶĞĐŬ;ŝĨŝŶĚŝĐĂƚĞĚͿĂƐǁĞůůĂƐŽƚŚĞƌƌĞůĞǀĂŶƚŝŵĂŐŝŶŐ͕
ĂƐĚĞƐĐƌŝďĞĚǀŝĂZ/^dǀϭ͘ϭ͕ǁŝůůďĞƵƐĞĚĨŽƌĚŝƐĞĂƐĞͬƌĞƐƉŽŶƐĞĂƐƐĞƐƐŵĞŶƚ͘ƐƐĞƐƐŵĞŶƚŽĨƌĞƐƉŽŶƐĞ
ĂŶĚƉƌŽŐƌĞƐƐŝŽŶǁŝůůďĞĚĞƚĞƌŵŝŶĞĚďǇƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌĂĐĐŽƌĚŝŶŐƚŽZ/^dǀϭ͘ϭ͘dŚĞƐĞĂƐƐĞƐƐŵĞŶƚƐǁŝůů
ďĞĐŽŶĚƵĐƚĞĚĂƚƐƚƵĚǇǀŝƐŝƚƐĂƐƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ͘hƉŽŶĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶŽƌŝŶŝƚŝĂƚŝŽŶŽĨŶĞǁ
ĂŶƚŝĐĂŶĐĞƌƚŚĞƌĂƉǇ͕ĚŝƐĞĂƐĞͬƌĞƐƉŽŶƐĞĂƐƐĞƐƐŵĞŶƚǁŝůůĐŽŶƐŝƐƚŽĨƐƵďƐĞƋƵĞŶƚĂŶƚŝĐĂŶĐĞƌƚŚĞƌĂƉŝĞƐĂŶĚ
ĚĂƚĞƐ͕ĚĂƚĞŽĨƉƌŽŐƌĞƐƐŝŽŶ;ŝĨŶŽƚĂůƌĞĂĚǇĐĂƉƚƵƌĞĚͿ͕ĂŶĚƐƵƌǀŝǀĂůƐƚĂƚƵƐ͘EŽƐƵďƐĞƋƵĞŶƚƌĂĚŝŽŐƌĂƉŚǇŝƐ
ƌĞƋƵŝƌĞĚŽŶĐĞĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶŚĂƐŽĐĐƵƌƌĞĚ͘
KŶŐŽŝŶŐĐŽŶĐŽŵŝƚĂŶƚƚŚĞƌĂƉŝĞƐ;ĨƌŽŵƐƵďũĞĐƚΖƐƉĂƌĞŶƚƐƚƵĚǇͿƐŚŽƵůĚďĞƌĞĐŽƌĚĞĚĂƚƐƚƵĚǇǀŝƐŝƚƐĂƐ
ƐƉĞĐŝĨŝĞĚŝŶ^ĞĐƚŝŽŶϮ ĂŶĚǁŝůůŝŶĐůƵĚĞƚŚĞŶĂŵĞƐŽĨĂůůĐŽŶĐŽŵŝƚĂŶƚŵĞĚŝĐĂƚŝŽŶƐ͕ďůŽŽĚƉƌŽĚƵĐƚƐ͕
ƉƌŽĐĞĚƵƌĞƐ͕ĂŶĚƌĂĚŝŽƚŚĞƌĂƉǇ͕ŝŶĐůƵĚŝŶŐĚĂƚĞƐŽĨĂĚŵŝŶŝƐƚƌĂƚŝŽŶ͕ĚŽƐĞƌĞŐŝŵĞŶ͕ƌŽƵƚĞŽĨĂĚŵŝŶŝƐƚƌĂƚŝŽŶ͕
ĂŶĚƉƵƌƉŽƐĞ͘
^ƵďũĞĐƚƐĞŶƌŽůůĞĚŝŶƌŵŽƌƌŵZĞƚƌĞĂƚŵĞŶƚǁŝůůĐŽŵƉůĞƚĞĨůƵŝĚƌĞƚĞŶƚŝŽŶƋƵĞƐƚŝŽŶŶĂŝƌĞƐƐƚĂƌƚŝŶŐ
ŽŶĂǇϭƚŚƌŽƵŐŚƚŚĞKdsŝƐŝƚ;ƌĞĨĞƌƚŽ^ĞĐƚŝŽŶϮͿ͘^ƵďũĞĐƚƐǁŝůůƌĞĐŽƌĚƚŚĞŝƌĚĂŝůǇǁĞŝŐŚƚƐŽƌŶĞǁ
ĞĚĞŵĂŽƌĚǇƐƉŶĞĂŽŶƚŚĞĨůƵŝĚƌĞƚĞŶƚŝŽŶƋƵĞƐƚŝŽŶŶĂŝƌĞ;ƉƉĞŶĚŝǆͿ͘&ůƵŝĚƌĞƚĞŶƚŝŽŶƋƵĞƐƚŝŽŶŶĂŝƌĞƐǁŝůů
ďĞĚŝƐƚƌŝďƵƚĞĚƚŽƐƵďũĞĐƚƐŽŶĂǇϭ͕ĂǇϭϱ͕ĂǇϮϵ͕ĂŶĚƚŚĞWŽƐƚͲǇĐůĞZĞƐƉŽŶƐĞƐƐĞƐƐŵĞŶƚsŝƐŝƚ͘ĂĐŚ
ƋƵĞƐƚŝŽŶŶĂŝƌĞƌĞĐŽƌĚƐƵƉƚŽϳĚĂǇƐŽĨĚĂŝůǇǁĞŝŐŚƚƐĂŶĚƐƵďũĞĐƚƐƐŚŽƵůĚďĞƉƌŽǀŝĚĞĚǁŝƚŚĞŶŽƵŐŚ
ƋƵĞƐƚŝŽŶŶĂŝƌĞƐƚŽƌĞĐŽƌĚƚŚĞŝƌĚĂŝůǇǁĞŝŐŚƚƵŶƚŝůƚŚĞŝƌŶĞǆƚŽŶͲƐŝƚĞĐůŝŶŝĐǀŝƐŝƚ͘
^ŝƚĞƐǁŝůůĐĂůůƐƵďũĞĐƚƐďĞƚǁĞĞŶŽŶͲƐŝƚĞĐůŝŶŝĐǀŝƐŝƚƐƚŽƌĞǀŝĞǁĐŽŵƉůĞƚĞĚĨůƵŝĚƌĞƚĞŶƚŝŽŶƋƵĞƐƚŝŽŶŶĂŝƌĞƐ͘
dŚĞĨůƵŝĚƌĞƚĞŶƚŝŽŶƋƵĞƐƚŝŽŶŶĂŝƌĞĨŽůůŽǁͲƵƉƉŚŽŶĞĐĂůůƐǁŝůůďĞƉĞƌĨŽƌŵĞĚĂƚĂǇϳнϮĂǇƐ͕
WĂŐĞϱϮŽĨϳϬ


Ɖ͘ϭϲ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ĂǇ ϮϮ н Ϯ ĂǇƐ͕ĂŶĚĂǇϯϲнϮĂǇƐ͘^ƵďũĞĐƚƐƐŚŽƵůĚďĞŝŶƐƚƌƵĐƚĞĚƚŽƵƐĞĂĐŽŶƐŝƐƚĞŶƚǁĞŝŐŚŝŶŐĚĞǀŝĐĞ
ƚŚƌŽƵŐŚŽƵƚƚŚĞƐƚƵĚǇ͘
ϰ ^&dzDEh>
ϰ͘ϭ DĞƚŚŽĚƐĂŶĚdŝŵŝŶŐŽĨ^ĂĨĞƚǇƐƐĞƐƐŵĞŶƚ
ĚǀĞƌƐĞǀĞŶƚZĞƉŽƌƚŝŶŐŝŶƌŵĂŶĚ^ƵďũĞĐƚƐǁŚŽZĞĐĞŝǀĞdƌĞĂƚŵĞŶƚŽƌZĞƚƌĞĂƚŵĞŶƚŝŶ
dŚŝƐ^ƚƵĚǇ
tŝƚŚŝŶƚŚĞϳϬĂǇ&ŽůůŽǁͲhƉWĞƌŝŽĚ
dƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚĂĚǀĞƌƐĞĞǀĞŶƚƐ;dƐͿĂŶĚƚƌĞĂƚŵĞŶƚĞŵĞƌŐĞŶƚƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚƐ;^ƐͿ ǁŝůů
ďĞĐŽůůĞĐƚĞĚ͖dƐĂŶĚƚƌĞĂƚŵĞŶƚĞŵĞƌŐĞŶƚ^ƐĂƌĞĚĞĨŝŶĞĚĂƐƚŚŽƐĞƚŚĂƚŽĐĐƵƌŽƌǁŽƌƐĞŶŽŶŽƌĂĨƚĞƌ
ƚŚĞĨŝƌƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐƵŶƚŝů ϳϬĚĂǇƐĂĨƚĞƌƚŚĞůĂƐƚĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͘
ĨƚĞƌƚŚĞϳϬĂǇ&ŽůůŽǁͲhƉWĞƌŝŽĚ
ůů^ƐƚŚĂƚŽĐĐƵƌĂĨƚĞƌƚŚĞƐĂĨĞƚǇƌĞƉŽƌƚŝŶŐƉĞƌŝŽĚƚŚĂƚĂƌĞĐŽŶƐŝĚĞƌĞĚƐƚƵĚǇĚƌƵŐͲƌĞůĂƚĞĚŝŶƚŚĞ
ŽƉŝŶŝŽŶŽĨƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌƐŚŽƵůĚĂůƐŽďĞƌĞƉŽƌƚĞĚ͘
ĚǀĞƌƐĞǀĞŶƚZĞƉŽƌƚŝŶŐŝŶƌŵƐƵďũĞĐƚƐǁŚŽĚŽŶŽƚZĞĐĞŝǀĞdƌĞĂƚŵĞŶƚŽƌZĞƚƌĞĂƚŵĞŶƚŝŶ
dŚŝƐ^ƚƵĚǇ
ůů^ƐƚŚĂƚĂƌĞĐŽŶƐŝĚĞƌĞĚƐƚƵĚǇĚƌƵŐͲƌĞůĂƚĞĚŝŶƚŚĞŽƉŝŶŝŽŶŽĨƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚ͘
ĞĂƚŚƐĚƵĞƚŽĂŶĐĞƌWƌŽŐƌĞƐƐŝŽŶ
ĞĂƚŚƐƚŚĂƚŽĐĐƵƌĚƵƌŝŶŐƚŚĞƉƌŽƚŽĐŽůƐƉĞĐŝĨŝĞĚͬ^ƌĞƉŽƌƚŝŶŐƉĞƌŝŽĚ;^ĞĐƚŝŽŶϮͿƚŚĂƚĂƌĞŵŽƌĞůŝŬĞůǇ
ƌĞůĂƚĞĚƚŽĚŝƐĞĂƐĞƉƌŽŐƌĞƐƐŝŽŶǁŝůůƚŚĞƌĞĨŽƌĞďĞĐŽŶƐŝĚĞƌĞĚĂƐĂŶĞǆƉĞĐƚĞĚĂŶĚǁŝůůŶŽƚďĞƐƵďũĞĐƚƚŽ
ĞǆƉĞĚŝƚĞĚƌĞƉŽƌƚŝŶŐ͘ĨƚĞƌƚŚĞƌĞƉŽƌƚŝŶŐƉĞƌŝŽĚ͕ĚĞĂƚŚƐĂƚƚƌŝďƵƚĞĚƚŽƉƌŽŐƌĞƐƐŝŽŶŽĨĚŝƐĞĂƐĞƵŶĚĞƌ
ƐƚƵĚǇƐŚŽƵůĚŶŽƚďĞƌĞĐŽƌĚĞĚŽŶƚŚĞĞZ&͕ďƵƚŽŶƚŚĞ^ƵƌǀŝǀĂůĞĂƚŚĞZ&͘
ĞĂƚŚƐŚŽƵůĚďĞĐŽŶƐŝĚĞƌĞĚĂŶŽƵƚĐŽŵĞĂŶĚŶŽƚĂĚŝƐƚŝŶĐƚĞǀĞŶƚ͘dŚĞĞǀĞŶƚŽƌĐŽŶĚŝƚŝŽŶƚŚĂƚĐĂƵƐĞĚŽƌ
ĐŽŶƚƌŝďƵƚĞĚƚŽƚŚĞĨĂƚĂůŽƵƚĐŽŵĞƐŚŽƵůĚďĞƌĞĐŽƌĚĞĚĂƐƚŚĞƐŝŶŐůĞŵĞĚŝĐĂůĐŽŶĐĞƉƚŽŶƚŚĞĞZ&͘
'ĞŶĞƌĂůůǇ͕ŽŶůǇϭƐƵĐŚĞǀĞŶƚƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚ͘dŚĞƚĞƌŵΗƐƵĚĚĞŶĚĞĂƚŚΗƐŚŽƵůĚŽŶůǇďĞƵƐĞĚĨŽƌƚŚĞ
ŽĐĐƵƌƌĞŶĐĞŽĨĂŶĂďƌƵƉƚĂŶĚƵŶĞǆƉĞĐƚĞĚĚĞĂƚŚĚƵĞƚŽƉƌĞƐƵŵĞĚĐĂƌĚŝĂĐĐĂƵƐĞƐŝŶĂƐƵďũĞĐƚǁŝƚŚŽƌ
ǁŝƚŚŽƵƚƉƌĞͲĞǆŝƐƚŝŶŐŚĞĂƌƚĚŝƐĞĂƐĞ͕ǁŝƚŚŝŶϭŚŽƵƌŽĨƚŚĞŽŶƐĞƚŽĨĂĐƵƚĞƐǇŵƉƚŽŵƐŽƌ͕ŝŶƚŚĞĐĂƐĞŽĨĂŶ
ƵŶǁŝƚŶĞƐƐĞĚĚĞĂƚŚ͕ǁŝƚŚŝŶϮϰŚŽƵƌƐĂĨƚĞƌƚŚĞƐƵďũĞĐƚǁĂƐůĂƐƚƐĞĞŶĂůŝǀĞĂŶĚƐƚĂďůĞ͘/ĨƚŚĞĐĂƵƐĞŽĨ
ĚĞĂƚŚŝƐƵŶŬŶŽǁŶĂŶĚĐĂŶŶŽƚďĞĂƐĐĞƌƚĂŝŶĞĚĂƚƚŚĞƚŝŵĞŽĨƌĞƉŽƌƚŝŶŐ͕ΗƵŶĞǆƉůĂŝŶĞĚĚĞĂƚŚΗƐŚŽƵůĚďĞ
ƌĞĐŽƌĚĞĚŽŶƚŚĞĞZ&͘/ĨƚŚĞĐĂƵƐĞŽĨĚĞĂƚŚůĂƚĞƌďĞĐŽŵĞƐĂǀĂŝůĂďůĞ;Ğ͘Ő͕͘ĂĨƚĞƌĂƵƚŽƉƐǇͿ͕
ΗƵŶĞǆƉůĂŝŶĞĚĚĞĂƚŚΗƐŚŽƵůĚďĞƌĞƉůĂĐĞĚďǇƚŚĞĞƐƚĂďůŝƐŚĞĚĐĂƵƐĞŽĨĚĞĂƚŚ͘
WĂŐĞϱϯŽĨϳϬ


Ɖ͘ϭϳ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
dŚĞƐƵƌǀŝǀĂůƐƚĂƚƵƐŽĨƐƵďũĞĐƚƐǁŝůůďĞĂƐĐĞƌƚĂŝŶĞĚĂĐĐŽƌĚŝŶŐƚŽĂƉƌĞĚĞƚĞƌŵŝŶĞĚĨŽůůŽǁͲƵƉƐĐŚĞĚƵůĞ
;^ĞĐƚŝŽŶ ϮͿ͘dŚĞĨŽůůŽǁͲƵƉƐĐŚĞĚƵůĞŝƐŝŶƚĞŶĚĞĚƚŽƉƌŽǀŝĚĞĨŽƌƚŚĞƐǇƐƚĞŵĂƚŝĐĂƐĐĞƌƚĂŝŶŵĞŶƚŽĨĞĂĐŚ
ƐƵďũĞĐƚΖƐƐƵƌǀŝǀĂůƐƚĂƚƵƐ;ĂůŝǀĞ͕ĚĞĂĚ͕ŽƌƵŶŬŶŽǁŶͬůŽƐƚƚŽĨŽůůŽǁͲƵƉͿƵŶƚŝůƚŚĞĐůŽƐƵƌĞŽĨƚŚĞĞǆƚĞŶƐŝŽŶ
ƐƚƵĚǇ͘&ŽƌƐƵďũĞĐƚƐůŽƐƚƚŽĨŽůůŽǁͲƵƉŽƌǁŚŽƐĞƐƵƌǀŝǀĂůƐƚĂƚƵƐŝƐƵŶŬŶŽǁŶ͕ĞǀĞƌǇĞĨĨŽƌƚǁŝůůďĞŵĂĚĞƚŽ
ĚĞƚĞƌŵŝŶĞƚŚĞĚĂƚĞƐƵĐŚƐƵďũĞĐƚƐǁĞƌĞůĂƐƚŬŶŽǁŶƚŽďĞĂůŝǀĞ͘^ƵĐŚĞĨĨŽƌƚƐŵĂǇŝŶĐůƵĚĞƉŚŽŶĞĐĂůůƐ͕
ĐĞƌƚŝĨŝĞĚŵĂŝů͕ĂŶĚƚŚĞĐŚĞĐŬŝŶŐŽĨƉƵďůŝĐƌĞĐŽƌĚƐ͘
/ŶĨŽƌŵĂƚŝŽŶǁŝůůďĞĐŽůůĞĐƚĞĚĂƐƚŚĞĚŝĂŐƌĂŵďĞůŽǁ͘
ϰ͘Ϯ ZĞĐŽƌĚŝŶŐĂƚĂĂŶĚŶĂůǇƐĞƐŽĨ^ĂĨĞƚǇ&ŝŶĚŝŶŐƐ
ĚǀĞƌƐĞĞǀĞŶƚƐǁŝůůďĞĐŽĚĞĚƵƐŝŶŐƚŚĞDĞĚŝĐĂůŝĐƚŝŽŶĂƌǇĨŽƌZĞŐƵůĂƚŽƌǇĐƚŝǀŝƚŝĞƐ;DĞĚZͿ͘dŚĞ
ƚĂďƵůĂƚŝŽŶŽĨƚŚĞŶƵŵďĞƌŽĨƐƵďũĞĐƚƐǁŝƚŚƚƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚĂĚǀĞƌƐĞĞǀĞŶƚƐďǇƐĞǀĞƌŝƚǇŐƌĂĚĞĂŶĚ
ƌĞůĂƚŝŽŶƐŚŝƉƚŽƐƚƵĚǇĚƌƵŐĂůƐŽǁŝůůďĞƌĞĐŽƌĚĞĚ͘^ƵďũĞĐƚƐƌĞƉŽƌƚŝŶŐŵŽƌĞƚŚĂŶϭĨŽƌĂŐŝǀĞŶDĞĚZ
ƉƌĞĨĞƌƌĞĚƚĞƌŵǁŝůůďĞĚŽĐƵŵĞŶƚĞĚŽŶůǇŽŶĐĞĨŽƌƚŚĂƚƚĞƌŵƵƐŝŶŐƚŚĞŵŽƐƚƐĞǀĞƌĞŐƌĂĚĞĂĐĐŽƌĚŝŶŐƚŽ
ƚŚĞƐĞǀĞƌŝƚǇŐƌĂĚĞƚĂďůĞĂŶĚƚŚĞŵŽƐƚƌĞůĂƚĞĚĂĐĐŽƌĚŝŶŐƚŽƚŚĞƌĞůĂƚŝŽŶƐŚŝƉƚŽƐƚƵĚǇĚƌƵŐƚĂďůĞƐ͘
^ƵďũĞĐƚƐƌĞƉŽƌƚŝŶŐŵŽƌĞƚŚĂŶϭƚǇƉĞŽĨĞǀĞŶƚǁŝƚŚŝŶĂ^ǇƐƚĞŵKƌŐĂŶůĂƐƐ;^KͿǁŝůůďĞĚŽĐƵŵĞŶƚĞĚ
ŽŶůǇŽŶĐĞĨŽƌƚŚĂƚ^K͘
WĂŐĞϱϰŽĨϳϬ




Ɖ͘ϭϵ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
dŚĞƐƉŽŶƐŽƌǁŝůůďĞƌĞƐƉŽŶƐŝďůĞĨŽƌ^ƵƐƉĞĐƚĞĚhŶĞǆƉĞĐƚĞĚ^ĞƌŝŽƵƐĚǀĞƌƐĞZĞĂĐƚŝŽŶƐ;^h^ZͿƌĞƉŽƌƚŝŶŐ
ĨŽƌƚŚĞ/ŶǀĞƐƚŝŐĂƚŝŽŶĂůDĞĚŝĐŝŶĂůWƌŽĚƵĐƚ;/DWͿŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚŝƌĞĐƚŝǀĞϮϬϬϭͬϮϬͬ͘
ϰ͘ϰ dŽǆŝĐŝƚǇDĂŶĂŐĞŵĞŶƚ
^ƚĂŶĚĂƌĚƐƵƉƉŽƌƚŝǀĞĐĂƌĞĨŽƌĚƌƵŐͲƌĞůĂƚĞĚƚŽǆŝĐŝƚǇŝƐƉĞƌŵŝƚƚĞĚ͕ŝŶĐůƵĚŝŶŐŐƌŽǁƚŚĨĂĐƚŽƌƐĂŶĚďůŽŽĚ
ƉƌŽĚƵĐƚƚƌĂŶƐĨƵƐŝŽŶƐƉĞƌůŽĐĂůŝŶƐƚŝƚƵƚŝŽŶĂůƐƚĂŶĚĂƌĚƐ͘KƚŚĞƌƐƚĂŶĚĂƌĚƐƵƉƉŽƌƚŝǀĞĐĂƌĞĨŽƌƐǇŵƉƚŽŵ
ĐŽŶƚƌŽůŽƌĚƌƵŐͲƌĞůĂƚĞĚƚŽǆŝĐŝƚǇŝƐĂůůŽǁĞĚ͕ƐƵĐŚĂƐĂŶĂůŐĞƐŝĐƐ͕ĂŶƚŝͲĞŵĞƚŝĐƐ͕ĞůĞĐƚƌŽůǇƚĞƌĞƉůĂĐĞŵĞŶƚ͕ĂŶĚ
ŚǇĚƌĂƚŝŽŶ͘ŽŶĞŵŽĚŝĨǇŝŶŐĂŐĞŶƚƐĨŽƌďŽŶĞŵĞƚĂƐƚĂƐĞƐĂƌĞĂůƐŽƉĞƌŵŝƚƚĞĚƉĞƌůŽĐĂůŝŶƐƚŝƚƵƚŝŽŶĂů
ƐƚĂŶĚĂƌĚƐ͘KƚŚĞƌƉƌĞƐĐƌŝďĞĚŵĞĚŝĐĂƚŝŽŶƐĨŽƌŶŽŶͲŶĞŽƉůĂƐƚŝĐĐŽŶĚŝƚŝŽŶƐĂƌĞĂůůŽǁĞĚ͕ĂƐǁĞůůĂƐǀŝƚĂŵŝŶƐ
ĂŶĚŶƵƚƌŝƚŝŽŶĂůƐƵƉƉůĞŵĞŶƚƐ͘
ZŽƵƚŝŶĞƉƌŽƉŚǇůĂǆŝƐǁŝƚŚǀĂĐĐŝŶĞƐŝƐƉĞƌŵŝƚƚĞĚ͖ŚŽǁĞǀĞƌ͕ǀĂĐĐŝŶĞƐƵƐĞĚƐŚŽƵůĚŶŽƚĐŽŶƚĂŝŶůŝǀĞŵŝĐƌŽͲ
ŽƌŐĂŶŝƐŵƐ͘
/ĨƚŚĞƐƵďũĞĐƚŝƐƚĂŬŝŶŐĐŚƌŽŶŝĐƐƵƉƉƌĞƐƐŝǀĞĂŶƚŝͲŝŶĨĞĐƚŝǀĞƐ;ĂŶƚŝǀŝƌĂů͕ĂŶƚŝĨƵŶŐĂů͕ŽƌĂŶƚŝďĂĐƚĞƌŝĂůͿ͕
ĂƉƉƌŽƉƌŝĂƚĞŝŶǀĞƐƚŝŐĂƚŝŽŶŵƵƐƚďĞĐŽŵƉůĞƚĞĚƉƌŝŽƌƚŽĞŶƌŽůůŵĞŶƚ͕ĂŶĚĚŽĐƵŵĞŶƚĂƚŝŽŶŵƵƐƚĞǆĐůƵĚĞ
ĂĐƚŝǀĞŝŶĨĞĐƚŝŽŶ͘dŚĞƐƵďũĞĐƚƐŚŽƵůĚĐŽŶƚŝŶƵĞƐƵƉƉƌĞƐƐŝǀĞĂŶƚŝͲŝŶĨĞĐƚŝǀĞƐĨŽƌƚŚĞĚƵƌĂƚŝŽŶŽĨƐƚƵĚǇ
ƉĂƌƚŝĐŝƉĂƚŝŽŶ͘
/ĨĂƐƵďũĞĐƚƌĞƋƵŝƌĞƐƉĂůůŝĂƚŝǀĞƌĂĚŝĂƚŝŽŶĚƵƌŝŶŐƚŚĞƐƚƵĚǇ;Ğ͘Ő͕͘ƐǇŵƉƚŽŵĂƚŝĐǁŽƌƐĞŶŝŶŐŽĨĂďŽŶĞůĞƐŝŽŶͿ
ĚŝĂŐŶŽƐƚŝĐŝŵĂŐŝŶŐŚĂƐƚŽďĞƉĞƌĨŽƌŵĞĚƚŽĂƐƐĞƐƐĨŽƌƌĂĚŝŽŐƌĂƉŚŝĐƉƌŽŐƌĞƐƐŝŽŶƉƌŝŽƌƚŽƌĂĚŝĂƚŝŽŶ͕ĂŶĚ
ĚŽĐƵŵĞŶƚĂƚŝŽŶŽĨŶŽŶͲƉƌŽŐƌĞƐƐŝǀĞƐƚĂƚƵƐďǇƌĂĚŝŽŐƌĂƉŚǇǁŝůůďĞĐĂƉƚƵƌĞĚŝŶƚŚĞĞZ&͘ŶǇĐĂŶĐĞƌͲ
ĚŝƌĞĐƚĞĚƚŚĞƌĂƉǇĂƐƵďũĞĐƚƌĞĐĞŝǀĞƐĚƵĞƚŽĚŝƐĞĂƐĞŝŵƉƌŽǀĞŵĞŶƚƐŚŽƵůĚďĞĚŝƐĐƵƐƐĞĚǁŝƚŚƚŚĞ
dŚĞƌĂƉĞƵƚŝĐƌĞĂDĞĚŝĐĂůŝƌĞĐƚŽƌŝŶĂĚǀĂŶĐĞ͕ŝĨƉŽƐƐŝďůĞ͘
/ŶƚŚĞĞǀĞŶƚŽĨŝƐŽůĂƚĞĚĐĞŶƚƌĂůŶĞƌǀŽƵƐƐǇƐƚĞŵ;E^ͿͲŽŶůǇƉƌŽŐƌĞƐƐŝŽŶĚƵƌŝŶŐƐƚƵĚǇƚƌĞĂƚŵĞŶƚ͕
ŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚŵĂǇďĞǁŝƚŚŚĞůĚǁŚŝůĞůŽĐĂůƚƌĞĂƚŵĞŶƚŝƐĂĚŵŝŶŝƐƚĞƌĞĚ;Ğ͘Ő͕͘ƌĂĚŝŽƚŚĞƌĂƉǇͿŝŶ
ĂĐĐŽƌĚĂŶĐĞǁŝƚŚŝŶƐƚŝƚƵƚŝŽŶĂůƉƌĂĐƚŝĐĞ͘/ŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚŵĂǇďĞƌĞƐƚĂƌƚĞĚϭǁĞĞŬĂĨƚĞƌƚŚĞ
ĐŽŵƉůĞƚŝŽŶŽĨůŽĐĂůE^ĚŝƐĞĂƐĞͲĚŝƌĞĐƚĞĚƚŚĞƌĂƉǇ͘/ĨŵŽƌĞƚŚĂŶϲǁĞĞŬƐŚĂǀĞĞůĂƉƐĞĚƐŝŶĐĞƚŚĞƉƌĞǀŝŽƵƐ
ĚŽƐĞŽĨƐƚƵĚǇĚƌƵŐ͕ƚŚĞƐƵďũĞĐƚƐŚŽƵůĚƵŶĚĞƌŐŽĂƌĂĚŝŽŐƌĂƉŚŝĐƚƵŵŽƌĂƐƐĞƐƐŵĞŶƚ͘/ĨĂĚĚŝƚŝŽŶĂůƐŝƚĞƐŽĨ
ƉƌŽŐƌĞƐƐŝǀĞĚŝƐĞĂƐĞĂƌĞƉƌĞƐĞŶƚ͕ƚŚĞƐƵďũĞĐƚǁŝůůďĞƌĞƋƵŝƌĞĚƚŽĚŝƐĐŽŶƚŝŶƵĞƐƚƵĚǇĚƌƵŐ͕ďƵƚŵĂǇďĞ
ĞůŝŐŝďůĞĨŽƌƌĞƚƌĞĂƚŵĞŶƚ͘
dƌĞĂƚŵĞŶƚŐƵŝĚĞůŝŶĞƐĨŽƌŚĞŵĂƚŽůŽŐŝĐƚŽǆŝĐŝƚŝĞƐ͕ĂŶĚƌĞĐŽŵŵĞŶĚĞĚĂĐƚŝŽŶƐƌĞŐĂƌĚŝŶŐƌŽǀĂůƉŝƚƵǌƵŵĂď
ƚĞƐŝƌŝŶĞĚŽƐŝŶŐ͕ĂƌĞŽƵƚůŝŶĞĚŝŶdĂďůĞ ϭ͘
WĂŐĞϱϲŽĨϳϬ


Ɖ͘ϮϬ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Table 1.
Guidelines for Managing Hematologic Toxicities
Toxicity
Recommended Actiona
for Rovalpituzumab Tesirine Doses
Toxicity on Day 1 of Cycle
WůĂƚĞůĞƚƐфϳϱ͕ϬϬϬͬђ>
•
,ŽůĚ
•
tŝƚŚƌĞƐŽůƵƚŝŽŶƌĞƐƚĂƌƚĂƚŽƌŝŐŝŶĂůĚŽƐĞĨŽƌŶĞǆƚ
ĐǇĐůĞ
•
/ĨŶŽƌĞƐŽůƵƚŝŽŶ͕ƌĞĚƵĐĞĚŽƐŝŶŐ
Eфϭ͕ϬϬϬͬђ>
•
,ŽůĚ
•
'ƌŽǁƚŚĨĂĐƚŽƌƐĂƌĞƌĞĐŽŵŵĞŶĚĞĚƚŽďĞƵƐĞĚƉĞƌ
^KͬEEͬŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐ
•
tŝƚŚƌĞƐŽůƵƚŝŽŶƌĞƐƚĂƌƚĂƚŽƌŝŐŝŶĂůĚŽƐĞĨŽƌŶĞǆƚ
ĐǇĐůĞ
•
/ĨŶŽƌĞƐŽůƵƚŝŽŶ͕ƌĞĚƵĐĞĚŽƐŝŶŐ
Toxicity on Subsequent Days of Cycle
WůĂƚĞůĞƚƐфϮϱ͕ϬϬϬͬђ>ĨŽƌŐƌĞĂƚĞƌƚŚĂŶϳĚĂǇƐ͕KZ
dŚƌŽŵďŽĐǇƚŽƉĞŶŝĂǁŝƚŚďůĞĞĚŝŶŐŽďƐĞƌǀĞĚŝŶƚŚĞ
ƉƌĞǀŝŽƵƐĐǇĐůĞ
•
,ŽůĚ
•
tŝƚŚƌĞƐŽůƵƚŝŽŶƌĞƐƚĂƌƚĂƚƌĞĚƵĐĞĚĚŽƐĞƉĞƌĨŽƌ
ŶĞǆƚĐǇĐůĞ
•
/ĨŶŽƌĞƐŽůƵƚŝŽŶ͕ĚŝƐĐŽŶƚŝŶƵĞĚŽƐŝŶŐ
EфϱϬϬͬђ>ĨŽƌŐƌĞĂƚĞƌƚŚĂŶϳĚĂǇƐ͕KZ
EĞƵƚƌŽƉĞŶŝĐĨĞǀĞƌ;Eфϭ͕ϬϬϬͬђ>ĂŶĚƐŝŶŐůĞ
ƚĞŵƉĞƌĂƚƵƌĞхϯϴ͘ϯΣŽƌƚĞŵƉĞƌĂƚƵƌĞхϯϴ͘ϬΣĨŽƌ
ŵŽƌĞƚŚĂŶϭŚŽƵƌͿ
•
,ŽůĚ
•
'ƌŽǁƚŚĨĂĐƚŽƌƐĂƌĞƌĞĐŽŵŵĞŶĚĞĚƚŽďĞƵƐĞĚƉĞƌ
^KͬEEͬŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐď
•
tŝƚŚƌĞƐŽůƵƚŝŽŶƌĞƐƚĂƌƚĂƚƌĞĚƵĐĞĚĚŽƐĞƉĞƌĨŽƌ
ŶĞǆƚĐǇĐůĞ
•
/ĨŶŽƌĞƐŽůƵƚŝŽŶ͕ĚŝƐĐŽŶƚŝŶƵĞĚŽƐŝŶŐ
ďďƌĞǀŝĂƚŝŽŶƐ͗EсĂďƐŽůƵƚĞŶĞƵƚƌŽƉŚŝůĐŽƵŶƚ͖^KсŵĞƌŝĐĂŶ^ŽĐŝĞƚǇŽĨůŝŶŝĐĂůKŶĐŽůŽŐǇ͖EĂƚŝŽŶĂůŽŵƉƌĞŚĞŶƐŝǀĞ
ĂŶĐĞƌEĞƚǁŽƌŬ
Ă͘
dŚĞŵĂǆŝŵƵŵĂůůŽǁĞĚĚŽƐĞŝŶƚĞƌƌƵƉƚŝŽŶŝƐϲǁĞĞŬƐ͘
ď͘
ŽůŽŶǇƐƚŝŵƵůĂƚŝŶŐĨĂĐƚŽƌƐŝŶĐůƵĚĞĨŝůŐƌĂƐƚŝŵŽƌƐĂƌŐƌĂŵŽƐƚŝŵ͘
^ƉĞĐŝĂůdŽǆŝĐŝƚǇDĂŶĂŐĞŵĞŶƚ
DĂŶĂŐĞŵĞŶƚŽĨ^ĞƌŽƐĂůĨĨƵƐŝŽŶƐͬ^ĞƌŽƐŝƚŝƐ
^ĞƌŽƐĂůĞĨĨƵƐŝŽŶƐ;ƉůĞƵƌĂů͕ƉĞƌŝĐĂƌĚŝĂůͿ͕ĂůŽŶĞŽƌŝŶĐŽŵďŝŶĂƚŝŽŶǁŝƚŚŐĞŶĞƌĂůŝǌĞĚŽƌƉĞƌŝƉŚĞƌĂůĞĚĞŵĂ
ĂŶĚͬŽƌŚǇƉŽĂůďƵŵŝŶĞŵŝĂ͕ŚĂǀĞďĞĞŶŽďƐĞƌǀĞĚǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘dŚĞƐĞĞǀĞŶƚƐŚĂǀĞƚŚĞ
ƉŽƚĞŶƚŝĂůƚŽďĞůŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐ;Ğ͘Ő͕͘ƉĞƌŝĐĂƌĚŝĂůƚĂŵƉŽŶĂĚĞͿ͕ƚŚĞƌĞĨŽƌĞĚĞǀĞůŽƉŵĞŶƚŽĨĂŶǇŽĨƚŚĞƐĞ
ĞǀĞŶƚƐŽƌǁŽƌƐĞŶŝŶŐĨƌŽŵďĂƐĞůŝŶĞǁĂƌƌĂŶƚƐƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶďǇƚŚĞŝŶǀĞƐƚŝŐĂƚŽƌŽƌĚĞƐŝŐŶĞĞ͘
WĂŐĞϱϳŽĨϳϬ


Ɖ͘Ϯϭ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
&ŽƌƐĞƌŽƐĂůĞĨĨƵƐŝŽŶƐĐŽŶƐŝĚĞƌĞĚĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚ;Ğ͘Ő͕͘ŐƌĂĚĞϮŽƌŚŝŐŚĞƌĂŶĚĐŽŶƐŝĚĞƌĞĚƌĞůĂƚĞĚƚŽ
ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞͿ͕ĂĚŵŝŶŝƐƚƌĂƚŝŽŶŽĨƐǇƐƚĞŵŝĐĐŽƌƚŝĐŽƐƚĞƌŽŝĚƐƐŚŽƵůĚďĞĐŽŶƐŝĚĞƌĞĚ;Ğ͘Ő͕͘Ă
ƚĂƉĞƌĞĚƌĞŐŝŵĞŶŽĨĚĞǆĂŵĞƚŚĂƐŽŶĞ͕ƐƵĐŚĂƐƵƉƚŽϴŵŐŽƌĂůůǇ/ĨŽƌϱĚĂǇƐ͕ĨŽůůŽǁĞĚďǇϰŵŐŽƌĂůůǇ
/ĨŽƌϱĚĂǇƐ͕ƚŚĞŶϮŵŐŽƌĂůůǇ/ĨŽƌϱĚĂǇƐͿ͘ůƚĞƌŶĂƚŝǀĞůǇ͕ ŶŽŶƐƚĞƌŽŝĚĂůƚŚĞƌĂƉŝĞƐŵĂǇďĞ
ĐŽŶƐŝĚĞƌĞĚ͕ƐƵĐŚĂƐŶŽŶͲƐƚĞƌŽŝĚĂůĂŶƚŝͲŝŶĨůĂŵŵĂƚŽƌǇĚƌƵŐƐ;Ğ͘Ő͕͘ŝďƵƉƌŽĨĞŶϰϬϬƚŽϲϬϬŵŐŽƌĂůůǇϯƚŽ
ϰ ƚŝŵĞƐĚĂŝůǇͿŽƌĐŽůĐŚŝĐŝŶĞ;Ğ͘Ő͕͘Ϭ͘ϲŵŐŽƌĂůůǇϮƚŽϯƚŝŵĞƐĚĂŝůǇͿĨŽƌϭƚŽϮǁĞĞŬƐ͘^ǇŵƉƚŽŵĂƚŝĐƉůĞƵƌĂů
ĂŶĚƉĞƌŝĐĂƌĚŝĂů ĞĨĨƵƐŝŽŶƐƐŚŽƵůĚďĞĚƌĂŝŶĞĚĂƐĂƉƉƌŽƉƌŝĂƚĞĨŽƌƐǇŵƉƚŽŵƌĞůŝĞĨ͘ĨĨƵƐŝŽŶƐĐĂŶ
ƌĞĐƵƌͬƌĞĂĐĐƵŵƵůĂƚĞĂĨƚĞƌĚƌĂŝŶĂŐĞ͘
DĂŶĂŐĞŵĞŶƚŽĨĚĞŵĂ
dŚĞŵĂũŽƌŝƚǇŽĨƚŚĞĞĚĞŵĂĞǀĞŶƚƐǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŚĂǀĞďĞĞŶƌĞƉŽƌƚĞĚĂƐůŽǁŐƌĂĚĞϭŽƌϮ
;ŵŝůĚŽƌŵŽĚĞƌĂƚĞͿ͖ ŚŽǁĞǀĞƌ͕ĂƐŵĂůůŶƵŵďĞƌŽĨĨĂƚĂůĞǀĞŶƚƐŽĨŐĞŶĞƌĂůŝǌĞĚĞĚĞŵĂŚĂǀĞďĞĞŶƌĞƉŽƌƚĞĚ
ǁŝƚŚƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞ͘WŚǇƐŝĐĂůĞǆĂŵƐĂŶĚŵŽŶŝƚŽƌŝŶŐŽĨǁĞŝŐŚƚŐĂŝŶĂŶĚƐŝŐŶƐŽƌƐǇŵƉƚŽŵƐŽĨ
ĨůƵŝĚƌĞƚĞŶƚŝŽŶƐŚŽƵůĚďĞĐŽŶĚƵĐƚĞĚĚƵƌŝŶŐƚƌĞĂƚŵĞŶƚ͘
ŽŶƐŝƐƚĞŶƚǁŝƚŚŝŶƐƚŝƚƵƚŝŽŶĂůŐƵŝĚĞůŝŶĞƐŽƌƐƚĂŶĚĂƌĚƉƌĂĐƚŝĐĞ͕ƚŚĞƵƐĞŽĨĚŝƵƌĞƚŝĐƐǁŝƚŚŽƌǁŝƚŚŽƵƚ
ĂůďƵŵŝŶŵĂǇďĞĐŽŶƐŝĚĞƌĞĚŝŶƐƵďũĞĐƚƐǁŝƚŚĐůŝŶŝĐĂůůǇƐŝŐŶŝĨŝĐĂŶƚĞĚĞŵĂĂŶĚŚǇƉŽĂůďƵŵŝŶĞŵŝĂ͘dŚĞ
ƐĞůĞĐƚŝŽŶĂŶĚƵƐĞŽĨĚŝƵƌĞƚŝĐƐŝŶƐƵďũĞĐƚƐƐŚŽƵůĚďĞďĂƐĞĚŽŶŝŶĚŝǀŝĚƵĂůĐůŝŶŝĐĂůĐŚĂƌĂĐƚĞƌŝƐƚŝĐƐĂŶĚ
ŝŶĐůƵĚĞŵŽŶŝƚŽƌŝŶŐŽĨĞůĞĐƚƌŽůǇƚĞƐƚĂƚƵƐĂŶĚƐŝŐŶƐŽƌƐǇŵƉƚŽŵƐŽĨŝŶƚƌĂǀĂƐĐƵůĂƌǀŽůƵŵĞĚĞƉůĞƚŝŽŶƐƵĐŚ
ĂƐŚǇƉŽƚĞŶƐŝŽŶĂŶĚŝŵƉĂŝƌĞĚƌĞŶĂůĨƵŶĐƚŝŽŶ͘
^ǇƐƚĞŵŝĐĐŽƌƚŝĐŽƐƚĞƌŽŝĚƐ͕ǁŚĞŶŝŶŝƚŝĂƚĞĚƉƌŽŵƉƚůǇ͕ŚĂǀĞďĞĞŶƌĞƉŽƌƚĞĚƚŽďĞďĞŶĞĨŝĐŝĂůŝŶƐŽŵĞƉƌŝŽƌ
ĐĂƐĞƐ͘
DĂŶĂŐĞŵĞŶƚŽĨ^ŬŝŶZĞĂĐƚŝŽŶƐ
ƵĞƚŽƚŚĞƉŽƚĞŶƚŝĂůĨŽƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞͲƌĞůĂƚĞĚƐŬŝŶƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ͕ƐƵďũĞĐƚƐƐŚŽƵůĚďĞ
ĂĚǀŝƐĞĚƚŽƚĂŬĞƚŚĞĨŽůůŽǁŝŶŐƉƌĞĐĂƵƚŝŽŶƐĨƌŽŵĂǇϭƵŶƚŝůϳϬĚĂǇƐĂĨƚĞƌƚŚĞůĂƐƚƚƌĞĂƚŵĞŶƚ͗ĂǀŽŝĚ
ƵŶƉƌŽƚĞĐƚĞĚƐƵŶĞǆƉŽƐƵƌĞ͕ƵƐĞĂďƌŽĂĚƐƉĞĐƚƌƵŵƐƵŶƐĐƌĞĞŶǁŝƚŚĂƐƵŶƉƌŽƚĞĐƚŝŽŶĨĂĐƚŽƌ;^W&ͿŽĨĂƚůĞĂƐƚ
ϯϬĂŶĚƌĞͲĂƉƉůǇƐƵŶƐĐƌĞĞŶĂƐĂĐƚŝǀŝƚǇͲĂƉƉƌŽƉƌŝĂƚĞ͕ĂŶĚǁĞĂƌƉƌŽƚĞĐƚŝǀĞĐůŽƚŚŝŶŐ͕ĂďƌŽĂĚͲďƌŝŵŵĞĚŚĂƚ͕
ĂŶĚƐƵŶŐůĂƐƐĞƐǁŚĞŶŽƵƚĚŽŽƌƐŽƌǁŚĞŶĚƌŝǀŝŶŐŽƌƌŝĚŝŶŐŝŶĂĐĂƌĨŽƌŵŽƌĞƚŚĂŶϭŚŽƵƌ͘
ůůĐƵƚĂŶĞŽƵƐƌĞĂĐƚŝŽŶƐƚŚĂƚĚĞǀĞůŽƉǁĂƌƌĂŶƚƉƌŽŵƉƚĞǀĂůƵĂƚŝŽŶďǇƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌŽƌĚĞƐŝŐŶĞĞ͘
ZĞĐŽŵŵĞŶĚĂƚŝŽŶƐĨŽƌŵĂŶĂŐĞŵĞŶƚŽĨƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇĂƌĞƐŚŽǁŶŝŶdĂďůĞ Ϯ͘^ŬŝŶƚŽǆŝĐŝƚǇǁŝƚŚ
ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŵĂǇĐŽŶƐŝƐƚŽĨƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇĂƐǁĞůůĂƐŽƚŚĞƌƌĞĂĐƚŝŽŶƐ;Ğ͘Ő͕͘ƉĂůŵĂƌͲƉůĂŶƚĂƌ
ĞƌǇƚŚƌŽĚǇƐĞƐƚŚĞƐŝĂ͕ĞƌǇƚŚĞŵĂŵƵůƚŝĨŽƌŵĞͿ͘ůůĞǀĞŶƚƐŽĨĐƵƚĂŶĞŽƵƐƚŽǆŝĐŝƚǇƐŚŽƵůĚďĞŵŽŶŝƚŽƌĞĚƵŶƚŝů
ƌĞƐŽůƵƚŝŽŶŽƌƌĞƚƵƌŶƚŽďĂƐĞůŝŶĞ͘
/ĨĐůŝŶŝĐĂůůǇĐŽŶƐŝƐƚĞŶƚǁŝƚŚƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ͕ƚŚĞƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚĂƐƐƵĐŚ;ƵƐŝŶŐŵĞĚŝĐĂůůǇĂĐĐƵƌĂƚĞ
ĂŶĚĚĞƐĐƌŝƉƚŝǀĞƚĞƌŵŝŶŽůŽŐǇͿ͕ĂŶĚŵĂŶĂŐĞĚĂƐĚĞƐĐƌŝďĞĚďĞůŽǁ͘
WĂŐĞϱϴŽĨϳϬ


Ɖ͘ϮϮ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
WŚŽƚŽͲĚŽĐƵŵĞŶƚĂƚŝŽŶƐŚŽƵůĚďĞĂǀĂŝůĂďůĞƵƉŽŶƌĞƋƵĞƐƚďǇƚŚĞdŚĞƌĂƉĞƵƚŝĐƌĞĂDĞĚŝĐĂůŝƌĞĐƚŽƌ
;d DͿ͘dŚĞŝŶǀĞƐƚŝŐĂƚŝǀĞƐŝƚĞǁŝůůƚĂŬĞŵĞĂƐƵƌĞƐƚŽƉƌŽƚĞĐƚƚŚĞŝĚĞŶƚŝƚǇŽĨƚŚĞƉĂƚŝĞŶƚ͘dŚĞƐĞ
ŵĞĂƐƵƌĞƐŝŶĐůƵĚĞƚĂŬŝŶŐƚŚĞƉŚŽƚŽŐƌĂƉŚǀĞƌǇĐůŽƐĞƚŽƚŚĞĂĨĨĞĐƚĞĚƐŬŝŶƌĞŐŝŽŶƚŽĞǆĐůƵĚĞĨĂĐŝĂůĨĞĂƚƵƌĞƐ͕
ŽƌŝĨĨĂĐŝĂůĨĞĂƚƵƌĞƐĐĂŶŶŽƚďĞĞǆĐůƵĚĞĚĚƵĞƚŽƚŚĞůŽĐĂƚŝŽŶŽĨƚŚĞƐŬŝŶƌĞĂĐƚŝŽŶ͕ĐŽǀĞƌŝŶŐŝĚĞŶƚŝĨǇŝŶŐ
ĨĞĂƚƵƌĞƐ;ƐƵĐŚĂƐƚŚĞĞǇĞƐͿǁŝƚŚĂďůĂĐŬƌĞĐƚĂŶŐůĞ͘
&ŽƌŵĂůĞǀĂůƵĂƚŝŽŶďǇĂĚĞƌŵĂƚŽůŽŐŝƐƚ͕ŝŶĐůƵĚŝŶŐƉŽƐƐŝďůĞƐŬŝŶďŝŽƉƐǇƚŽƌƵůĞŽƵƚĂůƚĞƌŶĂƚŝǀĞĞƚŝŽůŽŐŝĞƐ
ƐƵĐŚĂƐĞƌǇƚŚĞŵĂŵƵůƚŝĨŽƌŵĞ͕ǁŚŝĐŚŵĂǇǁĂƌƌĂŶƚĚŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚ͕ĂŶĚƚŽ
ĨĂĐŝůŝƚĂƚĞƚŚĞŵŽƐƚĂƉƉƌŽƉƌŝĂƚĞƚĞƌŵŝŶŽůŽŐǇĨŽƌƌĞƉŽƌƚŝŶŐ͘
Table 2.
Recommended Management of Photosensitivity
CTCAE v4.03
Treatment Recommendations
Rovalpituzumab 
Tesirine Dose 
Modifications
'ƌĂĚĞϭ
WĂŝŶůĞƐƐĞƌǇƚŚĞŵĂĂŶĚĞƌǇƚŚĞŵĂ
ĐŽǀĞƌŝŶŐфϭϬй^
>ŽǁͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ĨĂĐĞͿ
,ŝŐŚͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ďŽĚǇͿ
ͺ
'ƌĂĚĞϮ
dĞŶĚĞƌĞƌǇƚŚĞŵĂĐŽǀĞƌŝŶŐϭϬʹ
ϯϬй^
>ŽǁͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ĨĂĐĞͿ
,ŝŐŚͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ďŽĚǇͿ
EŽŶƐƚĞƌŽŝĚĂůĂŶƚŝͲŝŶĨůĂŵŵĂƚŽƌǇĂŐĞŶƚƐŽƌĂůůǇ
ĂƐŶĞĞĚĞĚ
ͺ
'ƌĂĚĞϯ
ƌǇƚŚĞŵĂĐŽǀĞƌŝŶŐхϯϬй^ĂŶĚ
ĞƌǇƚŚĞŵĂǁŝƚŚďůŝƐƚĞƌŝŶŐ͖
ƉŚŽƚŽƐĞŶƐŝƚŝǀŝƚǇ͖ŽƌĂů
ĐŽƌƚŝĐŽƐƚĞƌŽŝĚƚŚĞƌĂƉǇŝŶĚŝĐĂƚĞĚ͖
ƉĂŝŶĐŽŶƚƌŽůŝŶĚŝĐĂƚĞĚ
;Ğ͘Ő͕͘ ŶĂƌĐŽƚŝĐƐŽƌE^/ƐͿ
>ŽǁͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ĨĂĐĞͿ
,ŝŐŚͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ďŽĚǇͿ
WƌĞĚŶŝƐŽŶĞϬ͘ϱŵŐͬŬŐпϳĚĂǇƐ
ZĞĚƵĐĞĚŽƐĞ
'ƌĂĚĞϰ
>ŝĨĞͲƚŚƌĞĂƚĞŶŝŶŐĐŽŶƐĞƋƵĞŶĐĞƐ͖
ƵƌŐĞŶƚŝŶƚĞƌǀĞŶƚŝŽŶŝŶĚŝĐĂƚĞĚ
>ŽǁͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ĨĂĐĞͿ
,ŝŐŚͲƉŽƚĞŶĐǇƚŽƉŝĐĂůƐƚĞƌŽŝĚ;ďŽĚǇͿ
WƌĞĚŶŝƐŽŶĞϬ͘ϱŵŐͬŬŐпϳĚĂǇƐ
,ŽƐƉŝƚĂůŝǌĂƚŝŽŶ
ŝƐĐŽŶƚŝŶƵĞ
^сďŽĚǇƐƵƌĨĂĐĞĂƌĞĂ͖E^/сŶŽŶͲƐƚĞƌŽŝĚĂůĂŶƚŝͲŝŶĨůĂŵŵĂƚŽƌǇĚƌƵŐ
DĂŶĂŐĞŵĞŶƚŽĨƌƵŐͲ/ŶĚƵĐĞĚ>ŝǀĞƌ/ŶũƵƌǇ
tŚĞƌĞǀĞƌƉŽƐƐŝďůĞ͕ƚŝŵĞůǇĐŽŶĨŝƌŵĂƚŝŽŶŽĨŝŶŝƚŝĂůůŝǀĞƌͲƌĞůĂƚĞĚůĂďŽƌĂƚŽƌǇĂďŶŽƌŵĂůŝƚŝĞƐƐŚŽƵůĚŽĐĐƵƌ
ƉƌŝŽƌƚŽƚŚĞƌĞƉŽƌƚŝŶŐŽĨĂƉŽƚĞŶƚŝĂůĚƌƵŐͲŝŶĚƵĐĞĚůŝǀĞƌŝŶũƵƌǇĞǀĞŶƚ;/>/Ϳ͘ůůŽĐĐƵƌƌĞŶĐĞƐŽĨƉŽƚĞŶƚŝĂů
/>/ƐŵĞĞƚŝŶŐƚŚĞĚĞĨŝŶĞĚĐƌŝƚĞƌŝĂŵƵƐƚďĞƌĞƉŽƌƚĞĚĂƐ^Ɛ͘
ƉŽƚĞŶƚŝĂů/>/ŝƐĚĞĨŝŶĞĚĂƐ͗
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ůĂŶŝŶĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ;>dͿŽƌĂƐƉĂƌƚĂƚĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ;^dͿĞůĞǀĂƚŝŽŶхϯƚŝŵĞƐ
;ϯпͿ ƵƉƉĞƌůŝŵŝƚŽĨŶŽƌŵĂů;h>EͿĂŶĚ
WĂŐĞϱϵŽĨϳϬ


Ɖ͘Ϯϯ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
•
dŽƚĂůďŝůŝƌƵďŝŶ;d>ͿхϮпh>E͕ǁŝƚŚŽƵƚŝŶŝƚŝĂůĨŝŶĚŝŶŐƐŽĨĐŚŽůĞƐƚĂƐŝƐ;ĞůĞǀĂƚĞĚƐĞƌƵŵĂůŬĂůŝŶĞ
ƉŚŽƐƉŚĂƚĂƐĞͿĂŶĚ
•
EŽŽƚŚĞƌŝŵŵĞĚŝĂƚĞůǇ ĂƉƉĂƌĞŶƚƉŽƐƐŝďůĞĐĂƵƐĞƐŽĨĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ;dͿĞůĞǀĂƚŝŽŶĂŶĚ
ŚǇƉĞƌďŝůŝƌƵďŝŶĞŵŝĂŝŶĐůƵĚŝŶŐďƵƚŶŽƚůŝŵŝƚĞĚƚŽǀŝƌĂůŚĞƉĂƚŝƚŝƐ͕ƉƌĞͲĞǆŝƐƚŝŶŐĐŚƌŽŶŝĐŽƌĂĐƵƚĞůŝǀĞƌ
ĚŝƐĞĂƐĞŽƌƚƵŵŽƌ;ƐͿ͕ŽƌƚŚĞĂĚŵŝŶŝƐƚƌĂƚŝŽŶŽĨŽƚŚĞƌĚƌƵŐ;ƐͿŬŶŽǁŶƚŽďĞŚĞƉĂƚŽƚŽǆŝĐ
/ŶŐĞŶĞƌĂů͕ĂŶŝŶĐƌĞĂƐĞŽĨdƚŽхϯпh>EƐŚŽƵůĚďĞĨŽůůŽǁĞĚďǇƌĞƉĞĂƚƚĞƐƚŝŶŐǁŝƚŚŝŶϰϴƚŽϳϮŚŽƵƌƐŽĨ
ĂůůϰŽĨƚŚĞƵƐƵĂůŵĞĂƐƵƌĞƐ;>d͕^d͕ĂůŬĂůŝŶĞƉŚŽƐƉŚĂƚĂƐĞ͕ĂŶĚd>ͿƚŽĐŽŶĨŝƌŵƚŚĞĂďŶŽƌŵĂůŝƚŝĞƐĂŶĚ
ƚŽĚĞƚĞƌŵŝŶĞŝĨƚŚĞǇĂƌĞŝŶĐƌĞĂƐŝŶŐŽƌĚĞĐƌĞĂƐŝŶŐ͘ŶŝŶƋƵŝƌǇƌĞŐĂƌĚŝŶŐƐǇŵƉƚŽŵƐƐŚŽƵůĚĂůƐŽďĞŵĂĚĞ
;Ğ͘Ő͕͘ĨĂƚŝŐƵĞ͕ŶĂƵƐĞĂ͕ǀŽŵŝƚŝŶŐ͕ƌŝŐŚƚƵƉƉĞƌƋƵĂĚƌĂŶƚƉĂŝŶŽƌƚĞŶĚĞƌŶĞƐƐ͕ĨĞǀĞƌ͕ƌĂƐŚͿ͘^ƵďũĞĐƚƐŵĂǇďĞ
ƌĞƚĞƐƚĞĚůŽĐĂůůǇ͕ďƵƚŶŽƌŵĂůůĂďŽƌĂƚŽƌǇƌĂŶŐĞƐƐŚŽƵůĚďĞƌĞĐŽƌĚĞĚĂŶĚƌĞƐƵůƚƐŵĂĚĞĂǀĂŝůĂďůĞƚŽƚŚĞ
ŝŶǀĞƐƚŝŐĂƚŽƌŝŵŵĞĚŝĂƚĞůǇ͘ůůĚĂƚĂŵƵƐƚďĞƌĞĐŽƌĚĞĚŝŶƚŚĞĞZ&͘/ĨƐǇŵƉƚŽŵƐƉĞƌƐŝƐƚŽƌƌĞƉĞĂƚƚĞƐƚŝŶŐ
ƐŚŽǁƐdхϯпh>EĨŽƌƐƵďũĞĐƚƐǁŝƚŚŶŽƌŵĂůďĂƐĞůŝŶĞŵĞĂƐƵƌĞƐŽƌϮͲĨŽůĚŝŶĐƌĞĂƐĞƐĂďŽǀĞďĂƐĞůŝŶĞ
ǀĂůƵĞƐĨŽƌƐƵďũĞĐƚƐǁŝƚŚĞůĞǀĂƚĞĚǀĂůƵĞƐďĞĨŽƌĞĚƌƵŐĞǆƉŽƐƵƌĞ͕ĐůŽƐĞŽďƐĞƌǀĂƚŝŽŶƐŚŽƵůĚďĞŝŶŝƚŝĂƚĞĚ͘/Ĩ
ĐůŽƐĞŵŽŶŝƚŽƌŝŶŐŝƐŶŽƚƉŽƐƐŝďůĞ͕ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƐŚŽƵůĚďĞĚŝƐĐŽŶƚŝŶƵĞĚ͘
ůŽƐĞŽďƐĞƌǀĂƚŝŽŶŝŶĐůƵĚĞƐ͗
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ZĞƉĞĂƚŝŶŐůŝǀĞƌĞŶǌǇŵĞĂŶĚƐĞƌƵŵďŝůŝƌƵďŝŶƚĞƐƚƐϮŽƌϯƚŝŵĞƐǁĞĞŬůǇ͘&ƌĞƋƵĞŶĐǇŽĨƌĞƚĞƐƚŝŶŐ
ĐĂŶĚĞĐƌĞĂƐĞƚŽŽŶĐĞĂǁĞĞŬŽƌůĞƐƐŝĨĂďŶŽƌŵĂůŝƚŝĞƐƐƚĂďŝůŝǌĞŽƌƚŚĞƚƌŝĂůĚƌƵŐŚĂƐďĞĞŶ
ĚŝƐĐŽŶƚŝŶƵĞĚĂŶĚƚŚĞƐƵďũĞĐƚŝƐĂƐǇŵƉƚŽŵĂƚŝĐ͘
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KďƚĂŝŶŝŶŐĂŵŽƌĞĚĞƚĂŝůĞĚŚŝƐƚŽƌǇŽĨƐǇŵƉƚŽŵƐĂŶĚƉƌŝŽƌŽƌĐŽŶĐƵƌƌĞŶƚĚŝƐĞĂƐĞƐ
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KďƚĂŝŶŝŶŐĂŚŝƐƚŽƌǇŽĨĐŽŶĐŽŵŝƚĂŶƚĚƌƵŐƵƐĞ;ŝŶĐůƵĚŝŶŐŶŽŶƉƌĞƐĐƌŝƉƚŝŽŶŵĞĚŝĐĂƚŝŽŶƐĂŶĚŚĞƌďĂů
ĂŶĚĚŝĞƚĂƌǇƐƵƉƉůĞŵĞŶƚƉƌĞƉĂƌĂƚŝŽŶƐͿ͕ĂůĐŽŚŽůƵƐĞ͕ƌĞĐƌĞĂƚŝŽŶĂůĚƌƵŐƵƐĞ͕ĂŶĚƐƉĞĐŝĂůĚŝĞƚƐ
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ZƵůŝŶŐŽƵƚĂĐƵƚĞǀŝƌĂůŚĞƉĂƚŝƚŝƐƚǇƉĞƐ͕͕͕͕ĂŶĚ͖ĂƵƚŽŝŵŵƵŶĞŽƌĂůĐŽŚŽůŝĐŚĞƉĂƚŝƚŝƐ͖ŶŽŶͲ
ĂůĐŽŚŽůŝĐƐƚĞĂƚŽŚĞƉĂƚŝƚŝƐ͖ŚǇƉŽǆŝĐͬŝƐĐŚĞŵŝĐŚĞƉĂƚŽƉĂƚŚǇ͖ĂŶĚďŝůŝĂƌǇƚƌĂĐƚĚŝƐĞĂƐĞ
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KďƚĂŝŶŝŶŐĂŚŝƐƚŽƌǇŽĨĞǆƉŽƐƵƌĞƚŽĞŶǀŝƌŽŶŵĞŶƚĂůĐŚĞŵŝĐĂůĂŐĞŶƚƐ
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KďƚĂŝŶŝŶŐĂĚĚŝƚŝŽŶĂůƚĞƐƚƐƚŽĞǀĂůƵĂƚĞůŝǀĞƌĨƵŶĐƚŝŽŶ͕ĂƐĂƉƉƌŽƉƌŝĂƚĞ;Ğ͘Ő͕͘ŝŶƚĞƌŶĂƚŝŽŶĂů
ŶŽƌŵĂůŝǌĞĚƌĂƚŝŽ΀/EZ΁͕ĚŝƌĞĐƚďŝůŝƌƵďŝŶͿ
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ŽŶƐŝĚĞƌŝŶŐŐĂƐƚƌŽĞŶƚĞƌŽůŽŐǇŽƌŚĞƉĂƚŽůŽŐǇĐŽŶƐƵůƚĂƚŝŽŶƐ
ŝƐĐŽŶƚŝŶƵĂƚŝŽŶŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞƐŚŽƵůĚďĞĐŽŶƐŝĚĞƌĞĚŝĨƉŽƚĞŶƚŝĂů/>/ŝƐƐƵƐƉĞĐƚĞĚĂŶĚ͗
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>dŽƌ^dхϴпh>E
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>dŽƌ^dхϱпh>EĨŽƌŵŽƌĞƚŚĂŶϮǁĞĞŬƐ
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>dŽƌ^dхϯпh>EĂŶĚ ;d>хϮпh>EŽƌ/EZхϭ͘ϱͿ
WĂŐĞϲϬŽĨϳϬ


Ɖ͘Ϯϰ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
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>dŽƌ^dхϯпh>EǁŝƚŚƚŚĞĂƉƉĞĂƌĂŶĐĞŽĨĨĂƚŝŐƵĞ͕ŶĂƵƐĞĂ͕ǀŽŵŝƚŝŶŐ͕ƌŝŐŚƚƵƉƉĞƌƋƵĂĚƌĂŶƚ
ƉĂŝŶŽƌƚĞŶĚĞƌŶĞƐƐ͕ĨĞǀĞƌ͕ƌĂƐŚ͕ĂŶĚͬŽƌĞŽƐŝŶŽƉŚŝůŝĂ
ůůƐƵďũĞĐƚƐƐŚŽǁŝŶŐƉŽƐƐŝďůĞ/>/ƐŚŽƵůĚďĞĨŽůůŽǁĞĚƵŶƚŝůĂůůĂďŶŽƌŵĂůŝƚŝĞƐƌĞƚƵƌŶƚŽŶŽƌŵĂůŽƌƚŽƚŚĞ
ďĂƐĞůŝŶĞƐƚĂƚĞ͘
ϱ KhEdZzͲ^W/&/ZYh/ZDEd^
ϱ͘ϭ ^ĂŵƉůĞZĞƚĞŶƚŝŽŶZĞƋƵŝƌĞŵĞŶƚƐ
EŽƚĂƉƉůŝĐĂďůĞĨŽƌƚŚŝƐĞǆƚĞŶƐŝŽŶƐƚƵĚǇ͘
ϱ͘Ϯ ^h^ZZĞƉŽƌƚŝŶŐ
ďďsŝĞǁŝůůďĞƌĞƐƉŽŶƐŝďůĞĨŽƌ^h^ZƌĞƉŽƌƚŝŶŐĨŽƌƚŚĞ/DWŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚŐůŽďĂůĂŶĚůŽĐĂů
ŐƵŝĚĞůŝŶĞƐĂŶĚƉƉĞŶĚŝǆŽĨƚŚĞ/ŶǀĞƐƚŝŐĂƚŽƌƌŽĐŚƵƌĞǁŝůůƐĞƌǀĞĂƐƚŚĞZĞĨĞƌĞŶĐĞ^ĂĨĞƚǇ/ŶĨŽƌŵĂƚŝŽŶ
;Z^/Ϳ͘dŚĞZ^/ŝŶĞĨĨĞĐƚĂƚƚŚĞƐƚĂƌƚŽĨĂĞǀĞůŽƉŵĞŶƚ^ĂĨĞƚǇhƉĚĂƚĞZĞƉŽƌƚ;^hZͿƌĞƉŽƌƚŝŶŐƉĞƌŝŽĚ
ƐĞƌǀĞƐĂƐƚŚĞZ^/ĚƵƌŝŶŐƚŚĞƌĞƉŽƌƚŝŶŐƉĞƌŝŽĚ͘&ŽƌĨŽůůŽǁͲƵƉƌĞƉŽƌƚƐ͕ƚŚĞZ^/ŝŶƉůĂĐĞĂƚƚŚĞƚŝŵĞŽĨ
ŽĐĐƵƌƌĞŶĐĞŽĨƚŚĞΖƐƵƐƉĞĐƚĞĚΖƐĞƌŝŽƵƐĂĚǀĞƌƐĞƌĞĂĐƚŝŽŶǁŝůůďĞƵƐĞĚƚŽĂƐƐĞƐƐĞǆƉĞĐƚĞĚŶĞƐƐ͘
ϲ ^dhzZh'
ϲ͘ϭ dƌĞĂƚŵĞŶƚƐĚŵŝŶŝƐƚĞƌĞĚ
ZŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĂŶĚĚĞǆĂŵĞƚŚĂƐŽŶĞ;ŽƌĂůƚĞƌŶĂƚŝǀĞͿǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚĂƚ ƚŚĞǀŝƐŝƚƐůŝƐƚĞĚŝŶ
^ĞĐƚŝŽŶϮ͘'ĞŶĞƌĂůƐƚƵĚǇĚƌƵŐŝŶĨŽƌŵĂƚŝŽŶĨŽƌƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝƐƉƌĞƐĞŶƚĞĚŝŶdĂďůĞ ϯ͘
WĂŐĞϲϭŽĨϳϬ


Ɖ͘Ϯϱ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
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Table 3.
Investigational Products:  Rovalpituzumab Tesirine
Investigational Product Name
Rovalpituzumab Tesirine
ZŽƵƚĞŽĨĚŵŝŶŝƐƚƌĂƚŝŽŶ
/s
ŽŵďŝŶĂƚŝŽŶƌƵŐƐ
EŽƚĂƉƉůŝĐĂďůĞ
&ŽƌŵƵůĂƚŝŽŶ
ϭϬŵŐ
ϭϱŵŐ
ϯϬŵŐ
ŽƐĂŐĞ&Žƌŵ
WŽǁĚĞƌĨŽƌƐŽůƵƚŝŽŶĨŽƌŝŶĨƵƐŝŽŶŝŶϭϬŵŐ͕ϭϱŵŐ͕ŽƌϯϬŵŐǀŝĂů
;ϭϬ ŵŐͬŵ>ǁŚĞŶƌĞĐŽŶƐƚŝƚƵƚĞĚͿ
ŽƐĞĂŶĚƵŶŝƚƐ
Ϭ͘ϯŵŐͬŬŐŽƌƉƌĞǀŝŽƵƐůǇĂĚũƵƐƚĞĚĚŽƐĞ
ƌƵŐWƌĞƉĂƌĂƚŝŽŶ
ZĞĐŽŶƐƚŝƚƵƚŝŽŶŽĨůǇŽƉŚŝůŝǌĞĚƉŽǁĚĞƌǁŝƚŚƐƚĞƌŝůĞǁĂƚĞƌĨŽƌŝŶũĞĐƚŝŽŶ
ƉĞƌW
&ƌĞƋƵĞŶĐǇŽĨĂĚŵŝŶŝƐƚƌĂƚŝŽŶ
ĂǇϭŽĨĞǀĞƌǇĐǇĐůĞ
;ϭĐǇĐůĞсϰϮĚĂǇƐͬϲǁĞĞŬƐͿ͖
EŽƚĞ͗ŶŽƚĂĚŵŝŶŝƐƚĞƌĞĚĞǀĞƌǇƚŚŝƌĚĐǇĐůĞŝŶƌŵ
^ƚŽƌĂŐĞŽŶĚŝƚŝŽŶƐ
^ƚŽƌĞĚĂƚƌĞĨƌŝŐĞƌĂƚĞĚƚĞŵƉĞƌĂƚƵƌĞ;ϮΣƚŽϴΣͬϯϲΣƚŽϰϲΣ&Ϳ͕ƉƌŽƚĞĐƚĞĚ
ĨƌŽŵůŝŐŚƚ͕ĂŶĚŵƵƐƚŶŽƚďĞĨƌŽǌĞŶ͘^ƉĞĐŝĨŝĐƐƚŽƌĂŐĞĐŽŶĚŝƚŝŽŶƐĨŽƌ
ƌĞĐŽŶƐƚŝƚƵƚĞĚĂŶĚĚŝůƵƚĞĚ/WǁŝůůďĞƉƌŽǀŝĚĞĚŝŶĂƐĞƉĂƌĂƚĞĚŽĐƵŵĞŶƚ
ŽƵƚƐŝĚĞŽĨƚŚŝƐƉƌŽƚŽĐŽů
ZŽǀĂůƉŝƚƵǌƵŵĂďdĞƐŝƌŝŶĞ
ZŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞǁŝůůďĞƐƵƉƉůŝĞĚĂƐůǇŽƉŚŝůŝǌĞĚĚƌƵŐ͕ĂƐƐŚŽǁŶŝŶdĂďůĞ ϯ͘ZŽǀĂůƉŝƚƵǌƵŵĂď
ƚĞƐŝƌŝŶĞŝƐŝŶƚĞŶĚĞĚĨŽƌ/sŝŶĨƵƐŝŽŶĂĨƚĞƌĨƵƌƚŚĞƌĚŝůƵƚŝŽŶŝŶĂϱϬ ŵ>ŽƌϭϬϬ ŵ>ŝŶĨƵƐŝŽŶďĂŐ;ϱϬŵ>
ŝŶĨƵƐŝŽŶďĂŐŝƐƌĞĐŽŵŵĞŶĚĞĚͿĐŽŶƚĂŝŶŝŶŐϬ͘ϵй^ŽĚŝƵŵŚůŽƌŝĚĞ/ŶũĞĐƚŝŽŶ͕h^W͕ŽƌĞƋƵŝǀĂůĞŶƚ͕ƚŽĂĐŚŝĞǀĞ
ƚŚĞĚĞƐŝƌĞĚĚŽƐĞůĞǀĞůĨŽƌĂĚŵŝŶŝƐƚƌĂƚŝŽŶ͘ZŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞǁŝůůďĞŝŶĨƵƐĞĚŽǀĞƌϯϬŵŝŶƵƚĞƐ
;ϮϬ Ͳ ϰϱŵŝŶƵƚĞŝŶĨƵƐŝŽŶǁŝŶĚŽǁͿ͘dŚĞƌĂƚĞƐŚŽƵůĚďĞĂĚũƵƐƚĞĚďĂƐĞĚŽŶƉĂƚŝĞŶƚƚŽůĞƌĂďŝůŝƚǇ͘&ƵƌƚŚĞƌ
ĚĞƚĂŝůƐƌĞŐĂƌĚŝŶŐƌĞĐŽŶƐƚŝƚƵƚŝŽŶŽĨƐƚƵĚǇĚƌƵŐĂƌĞƉƌŽǀŝĚĞĚŝŶƚŚĞĞǆƚĞŵƉŽƌĂŶĞŽƵƐĚŽƐĞƉƌĞƉĂƌĂƚŝŽŶ
;WͿ͘
^ŝŶĐĞƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĚŽƐŝŶŐŝƐďĂƐĞĚŽŶďŽĚǇǁĞŝŐŚƚ͕ŵƵůƚŝƉůĞǀŝĂůƐŽĨƌĞĐŽŶƐƚŝƚƵƚĞĚĚƌƵŐ
ƉƌŽĚƵĐƚŵĂǇďĞƌĞƋƵŝƌĞĚƚŽĂĐŚŝĞǀĞƚŚĞĚĞƐŝƌĞĚ ĚŽƐĞ͘^ƉĞĐŝĨŝĐĚŽƐĞƉƌĞƉĂƌĂƚŝŽŶĂŶĚĚŽĐƵŵĞŶƚĂƚŝŽŶ
ĚĞƚĂŝůƐǁŝůůďĞƉƌŽǀŝĚĞĚƚŽƚŚĞƐŝƚĞƉŚĂƌŵĂĐǇŝŶĂƐĞƉĂƌĂƚĞĚŽĐƵŵĞŶƚ͘
ĐŽŵƉůĞƚĞĚĞƐĐƌŝƉƚŝŽŶŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĐŚĞŵŝƐƚƌǇĂŶĚĨŽƌŵƵůĂƚŝŽŶŵĂǇďĞĨŽƵŶĚŝŶƚŚĞ
/ŶǀĞƐƚŝŐĂƚŽƌΖƐƌŽĐŚƵƌĞ͘
ĞǆĂŵĞƚŚĂƐŽŶĞ ;ŽƌƋƵŝǀĂůĞŶƚŽƌƚŝĐŽƐƚĞƌŽŝĚͿ
ĞǆĂŵĞƚŚĂƐŽŶĞƚĂďůĞƚƐ;ǀĂƌŝŽƵƐĨŽƌŵƵůĂƚŝŽŶƐͿĂƌĞƚŽďĞƚĂŬĞŶŽƌĂůůǇĂƚĂĚŽƐĞŽĨϴŵŐ/͘
ĞǆĂŵĞƚŚĂƐŽŶĞǁŝůůďĞƐĞůĨͲĂĚŵŝŶŝƐƚĞƌĞĚďǇƐƵďũĞĐƚƐŽŶĂǇʹϭ͕ĂǇϭ͕ĂŶĚĂǇϮŽĨĞĂĐŚĐǇĐůĞǁŚĞŶ
WĂŐĞϲϮŽĨϳϬ


Ɖ͘Ϯϲ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
ƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝƐƚĂŬĞŶŽŶĂǇϭŽĨƚŚĞƐĂŵĞĐǇĐůĞ͘dŚĞĨŝƌƐƚĚŽƐĞŽĨĚĞǆĂŵĞƚŚĂƐŽŶĞŽŶĂǇϭ
ƐŚŽƵůĚďĞĂƚůĞĂƐƚϯϬŵŝŶƵƚĞƐďƵƚŶŽŵŽƌĞƚŚĂŶϰŚŽƵƌƐƉƌŝŽƌƚŽƚŚĞƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞŝŶĨƵƐŝŽŶ͘
;EŽƚĞ͗/ĨƚŚĞĚŽƐĞŽĨĚĞǆĂŵĞƚŚĂƐŽŶĞŝƐǀŽŵŝƚĞĚǁŝƚŚŝŶϭϱŵŝŶƵƚĞƐŽĨƚĂŬŝŶŐƚŚĞŵĞĚŝĐĂƚŝŽŶ͕ƚŚĞƐƵďũĞĐƚ
ƐŚŽƵůĚƌĞƚĂŬĞƚŚĞŵĞĚŝĐĂƚŝŽŶ͘Ϳ/ĨƐƵƉƉůŝĞĚďǇďďsŝĞ͕ĚĞǆĂŵĞƚŚĂƐŽŶĞǁŝůůďĞĚŝƐƉĞŶƐĞĚƚŚƌŽƵŐŚ
/ŶƚĞƌĂĐƚŝǀĞZĞƐƉŽŶƐĞdĞĐŚŶŽůŽŐǇ;/ZdͿ͖ŝĨƐŽƵƌĐĞĚůŽĐĂůůǇ͕ĚĞǆĂŵĞƚŚĂƐŽŶĞǁŝůůŶŽƚďĞĚŝƐƉĞŶƐĞĚƚŚƌŽƵŐŚ
/Zd͘
ůƚĞƌŶĂƚŝǀĞƐƚŽĚĞǆĂŵĞƚŚĂƐŽŶĞŝŶĐůƵĚĞĐŽƌƚŝĐŽƐƚĞƌŽŝĚƐĂĚŵŝŶŝƐƚĞƌĞĚŝŶĞƋƵŝǀĂůĞŶƚĚŽƐĞƐ
;ŝ͘Ğ͕͘ ŵĞƚŚǇůƉƌĞĚŶŝƐŽůŽŶĞ͕ƉƌĞĚŶŝƐŽŶĞ͕ĞƚĐ͘Ϳ͘
ďďsŝĞǁŝůůŶŽƚƌŽƵƚŝŶĞůǇƉƌŽǀŝĚĞĚĞǆĂŵĞƚŚĂƐŽŶĞ;ŽƌŝƚƐĞƋƵŝǀĂůĞŶƚͿƵŶůĞƐƐƐƉĞĐŝĨŝĞĚŝŶŽƉĞƌĂƚŝŽŶĂůŽƌ
ƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ;ŝ͘Ğ͕͘ůŽĐĂůƐŝƚĞͬĐŽƵŶƚƌǇͲƐƉĞĐŝĨŝĐƌĞƋƵŝƌĞŵĞŶƚƐͿ͘EŽŶͲŝŶǀĞƐƚŝŐĂƚŝŽŶĂůŵĞĚŝĐŝŶĂů
ƉƌŽĚƵĐƚ;ƐƚĂŶĚĂƌĚŽĨĐĂƌĞͿŵƵƐƚďĞŽďƚĂŝŶĞĚĐŽŵŵĞƌĐŝĂůůǇĨƌŽŵĂůŝĐĞŶƐĞĚƉŚĂƌŵĂĐǇŽƌǁŚŽůĞƐĂůĞƌ͘
ĂĐŚƐŝƚĞǁŝůůďĞƌĞƐƉŽŶƐŝďůĞĨŽƌŵĂŝŶƚĂŝŶŝŶŐĚƌƵŐĂĐĐŽƵŶƚĂďŝůŝƚǇƌĞĐŽƌĚƐ͕ŝŶĐůƵĚŝŶŐƉƌŽĚƵĐƚĚĞƐĐƌŝƉƚŝŽŶ͕
ŵĂŶƵĨĂĐƚƵƌĞƌ͕ĂŶĚůŽƚŶƵŵďĞƌƐĨŽƌĂůůŶŽŶͲŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚƐĚŝƐƉĞŶƐĞĚďǇƚŚĞƐŝƚĞ͘
ϲ͘Ϯ WĂĐŬĂŐŝŶŐĂŶĚ>ĂďĞůŝŶŐ
sŝĂůƐŽĨƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞǁŝůůďĞƉĂĐŬĂŐĞĚŝŶĐĂƌƚŽŶƐ͘ĂĐŚǀŝĂůĂŶĚĐĂƌƚŽŶǁŝůůďĞůĂďĞůĞĚƉĞƌ
ĐŽƵŶƚƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͘dŚĞůĂďĞůƐŵƵƐƚƌĞŵĂŝŶĂĨĨŝǆĞĚƚŽƚŚĞǀŝĂůĂŶĚĐĂƌƚŽŶ͘ůůďůĂŶŬƐƉĂĐĞƐƐŚŽƵůĚďĞ
ĐŽŵƉůĞƚĞĚďǇƐŝƚĞƐƚĂĨĨƉƌŝŽƌƚŽĚŝƐƉĞŶƐŝŶŐ͘
ĞǆĂŵĞƚŚĂƐŽŶĞƐƵƉƉůŝĞĚůŽĐĂůůǇǁŝůůďĞƉƌŽǀŝĚĞĚŝŶĐŽŵŵĞƌĐŝĂůƉĂĐŬĂŐŝŶŐ͘/ĨƐƵƉƉůŝĞĚďǇďďsŝĞ͕
ĚĞǆĂŵĞƚŚĂƐŽŶĞǁŝůůďĞƉƌŽǀŝĚĞĚŝŶĐŽŵŵĞƌĐŝĂůƉƌŝŵĂƌǇƉĂĐŬĂŐŝŶŐǁŝƚŚĂƐƚƵĚǇůĂďĞůĂĨĨŝǆĞĚƚŽƚŚĞ
ƉƌŝŵĂƌǇĐŽŶƚĂŝŶĞƌĂŶĚͬŽƌƐĞĐŽŶĚĂƌǇƉĂĐŬĂŐŝŶŐ͘ĂĐŚďŽƚƚůĞ͕ĐĂƌƚŽŶĂŶĚͬŽƌďůŝƐƚĞƌǁŝůůďĞůĂďĞůĞĚƉĞƌ
ĐŽƵŶƚƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͘>ĂďĞůƐŵƵƐƚƌĞŵĂŝŶĂĨĨŝǆĞĚ͘ůůďůĂŶŬƐƉĂĐĞƐƐŚŽƵůĚďĞĐŽŵƉůĞƚĞĚďǇƐŝƚĞƐƚĂĨĨ
ƉƌŝŽƌƚŽĚŝƐƉĞŶƐŝŶŐ͘
^ƚŽƌĂŐĞĂŶĚŝƐƉŽƐŝƚŝŽŶŽĨ^ƚƵĚǇƌƵŐƐ
dŚĞůǇŽƉŚŝůŝǌĞĚĨŽƌŵƵůĂƚŝŽŶƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĚƌƵŐƉƌŽĚƵĐƚƐŚŽƵůĚďĞƐƚŽƌĞĚĂƚƌĞĨƌŝŐĞƌĂƚĞĚ
ƚĞŵƉĞƌĂƚƵƌĞ;ϮΣƚŽϴΣͬϯϲΣƚŽϰϲΣ&Ϳ͕ƉƌŽƚĞĐƚĞĚĨƌŽŵůŝŐŚƚ͕ĂŶĚŵƵƐƚŶŽƚďĞĨƌŽǌĞŶ͘^ƉĞĐŝĨŝĐƐƚŽƌĂŐĞ
ĐŽŶĚŝƚŝŽŶƐĨŽƌƌĞĐŽŶƐƚŝƚƵƚĞĚĂŶĚĚŝůƵƚĞĚŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚǁŝůůďĞƉƌŽǀŝĚĞĚŝŶĂƐĞƉĂƌĂƚĞĚŽĐƵŵĞŶƚ
ŽƵƚƐŝĚĞŽĨƚŚŝƐƉƌŽƚŽĐŽůͬŽƉĞƌĂƚŝŽŶƐŵĂŶƵĂů͘
&ŽƌĂůůƐƚŽƌĂŐĞĂƌĞĂƐĂŶĚƌĞĨƌŝŐĞƌĂƚŽƌƐ͕ƚĞŵƉĞƌĂƚƵƌĞůŽŐƐǁŝůůďĞŵĂŝŶƚĂŝŶĞĚƚŽĚŽĐƵŵĞŶƚƉƌŽƉĞƌƐƚŽƌĂŐĞ
ĐŽŶĚŝƚŝŽŶƐ͘dŚĞƚĞŵƉĞƌĂƚƵƌĞŵƵƐƚďĞƌĞĐŽƌĚĞĚŽŶƚĞŵƉĞƌĂƚƵƌĞůŽŐƐƚŽǀĞƌŝĨǇƉƌŽƉĞƌĨƵŶĐƚŝŽŶŽŶĞĂĐŚ
ďƵƐŝŶĞƐƐĚĂǇ͘dĞŵƉĞƌĂƚƵƌĞĞǆĐƵƌƐŝŽŶƐŵƵƐƚďĞƌĞƉŽƌƚĞĚƚŽďďsŝĞŝŵŵĞĚŝĂƚĞůǇ͘^ŝƚĞƐƐŚŽƵůĚƵƐĞƚŚĞ
ďďsŝĞdĞŵƉĞƌĂƚƵƌĞǆĐƵƌƐŝŽŶDĂŶĂŐĞŵĞŶƚ^ǇƐƚĞŵ;dD^ͿŵŽĚƵůĞǀŝĂ/ŶƚĞƌĂĐƚŝǀĞZĞƐƉŽŶƐĞ
dĞĐŚŶŽůŽŐǇ;/ZdͿ͕ŝĨĂǀĂŝůĂďůĞ͕ŽƌĨĂǆĐŽƉŝĞƐŽĨƚŚĞƚĞŵƉĞƌĂƚƵƌĞůŽŐŝŶĚŝĐĂƚŝŶŐƚŚĞĞǆƚĞŶƚŽĨƚŚĞĞǆĐƵƌƐŝŽŶ
;ƚŝŵĞ͕ĚƵƌĂƚŝŽŶŽĨƚŚĞƚĞŵƉĞƌĂƚƵƌĞĞǆĐƵƌƐŝŽŶ͕ŵŝŶͬŵĂǆǀĂůƵĞƐĂŶĚƐƚƵĚǇĚƌƵŐƐĂĨĨĞĐƚĞĚͿƚŽďďsŝĞ
ůŝŶŝĐĂůƌƵŐ^ƵƉƉůǇDĂŶĂŐĞŵĞŶƚ;^DͿŝŶĐůƵĚŝŶŐƚŚĞ^ƚŽƌĂŐĞdĞŵƉĞƌĂƚƵƌĞǆĐƵƌƐŝŽŶZĞƉŽƌƚŝŶŐ&Žƌŵ͘
WĂŐĞϲϯŽĨϳϬ


Ɖ͘Ϯϳ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
/ŶĐĂƐĞŽĨĂƚĞŵƉĞƌĂƚƵƌĞĞǆĐƵƌƐŝŽŶ͕ƐƚƵĚǇŵĞĚŝĐĂƚŝŽŶƐŚŽƵůĚďĞƋƵĂƌĂŶƚŝŶĞĚĂŶĚŶŽƚĚŝƐƉĞŶƐĞĚƵŶƚŝů
ďďsŝĞ^DŽƌdD^ĚĞĞŵƐƚŚĞŵĞĚŝĐĂƚŝŽŶĂƐĂĐĐĞƉƚĂďůĞ͘
ĞǆĂŵĞƚŚĂƐŽŶĞƐƵƉƉůŝĞĚďǇďďsŝĞƐŚŽƵůĚďĞƐƚŽƌĞĚĂƚϭϱΣƚŽϮϱΣ;ϱϵΣƚŽϳϳΣ&Ϳ͕ƉƌŽƚĞĐƚĞĚĨƌŽŵůŝŐŚƚ
ĂŶĚŵŽŝƐƚƵƌĞ͕ĂŶĚǁŝůůďĞƉƌŽǀŝĚĞĚŝŶĐŽŵŵĞƌĐŝĂůƉƌŝŵĂƌǇƉĂĐŬĂŐŝŶŐǁŝƚŚĂƐƚƵĚǇůĂďĞůĂĨĨŝǆĞĚƚŽƚŚĞ
ƉƌŝŵĂƌǇĐŽŶƚĂŝŶĞƌĂŶĚͬŽƌƐĞĐŽŶĚĂƌǇƉĂĐŬĂŐŝŶŐ͘ĂĐŚďŽƚƚůĞ͕ĐĂƌƚŽŶ͕ĂŶĚͬŽƌďůŝƐƚĞƌǁŝůůďĞůĂďĞůĞĚƉĞƌ
ĐŽƵŶƚƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͘>ĂďĞůƐŵƵƐƚƌĞŵĂŝŶĂĨĨŝǆĞĚƚŽƚŚĞďŽƚƚůĞ͕ĐĂƌƚŽŶ͕ĂŶĚͬŽƌďůŝƐƚĞƌ͘/Ĩ
ĚĞǆĂŵĞƚŚĂƐŽŶĞŝƐŽďƚĂŝŶĞĚůŽĐĂůůǇĨƌŽŵĐŽŵŵĞƌĐŝĂůƐŽƵƌĐĞƐ͕ƚŚĞĂƉƉƌŽǀĞĚƉƌŽĚƵĐƚůĂďĞůŝŶŐƐŚŽƵůĚďĞ
ƌĞĨĞƌĞŶĐĞĚĨŽƌĂƉƉƌŽƉƌŝĂƚĞƐƚŽƌĂŐĞĐŽŶĚŝƚŝŽŶƐ͘
dŚĞŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƉƌŽĚƵĐƚƐĂƌĞĨŽƌŝŶǀĞƐƚŝŐĂƚŝŽŶĂůƵƐĞŽŶůǇĂŶĚĂƌĞƚŽďĞƵƐĞĚŽŶůǇǁŝƚŚŝŶƚŚĞĐŽŶƚĞǆƚ
ŽĨƚŚŝƐƐƚƵĚǇ͘dŚĞƐƚƵĚǇĚƌƵŐƐƐƵƉƉůŝĞĚĨŽƌƚŚŝƐƐƚƵĚǇŵƵƐƚďĞŵĂŝŶƚĂŝŶĞĚƵŶĚĞƌĂĚĞƋƵĂƚĞƐĞĐƵƌŝƚǇĂŶĚ
ƐƚŽƌĞĚƵŶĚĞƌƚŚĞĐŽŶĚŝƚŝŽŶƐƐƉĞĐŝĨŝĞĚŽŶƚŚĞůĂďĞůƵŶƚŝůĚŝƐƉĞŶƐĞĚĨŽƌƐƵďũĞĐƚƵƐĞ͕ĚĞƐƚƌŽǇĞĚŽŶƐŝƚĞ͕Žƌ
ƌĞƚƵƌŶĞĚƚŽďďsŝĞŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚůŽĐĂůƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐĂŶĚďďsŝĞƌĞƋƵŝƌĞŵĞŶƚƐ͘
ϲ͘ϯ DĞƚŚŽĚŽĨƐƐŝŐŶŝŶŐ^ƵďũĞĐƚƐƚŽ^ƚƵĚǇƌŵƐ
^ƵďũĞĐƚƐĞŶƌŽůůĞĚŝŶƚŽ^ƚƵĚǇDϭϲͲϮϵϭǁŝůůďĞĂĚŵŝŶŝƐƚĞƌĞĚĂƌŽǀĂůƉŝƚƵǌƵŵĂďƚĞƐŝƌŝŶĞĚŽƐĞďĂƐĞĚŽŶ
ǁŚĞƚŚĞƌƚŚĞƐƵďũĞĐƚŚĂĚƌĞĐĞŝǀĞĚĂĚŽƐĞƌĞĚƵĐƚŝŽŶŝŶƚŚĞƉĂƌĞŶƚƐƚƵĚǇ;ĚĞƚĂŝůƐŝŶƚŚĞWƌŽƚŽĐŽů͕
^ĞĐƚŝŽŶ ϰ͘ϮͿ͘ĞƚĂŝůƐŽŶƐƚƵĚǇĚƌƵŐŝŶĨŽƌŵĂƚŝŽŶĂƌĞƉƌŽǀŝĚĞĚŝŶ^ĞĐƚŝŽŶϲ͘ϭ͘
WĂŐĞϲϰŽĨϳϬ


Ɖ͘Ϯϴ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX A. STUDY SPECIFIC ABBREVIATIONS AND TERMS
ďďƌĞǀŝĂƚŝŽŶ
ĞĨŝŶŝƚŝŽŶ

ĂĚǀĞƌƐĞĞǀĞŶƚ
>d
ĂůĂŶŝŶĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ
E
ĂďƐŽůƵƚĞŶĞƵƚƌŽƉŚŝůĐŽƵŶƚ
^K
ŵĞƌŝĐĂŶ^ŽĐŝĞƚǇŽĨůŝŶŝĐĂůKŶĐŽůŽŐǇ
^d
ĂƐƉĂƌƚĂƚĞĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ
d
ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ
dD^
ďďsŝĞdĞŵƉĞƌĂƚƵƌĞǆĐƵƌƐŝŽŶDĂŶĂŐĞŵĞŶƚ^ǇƐƚĞŵ
/
ƚǁŝĐĞĚĂŝůǇ
^
ďŽĚǇƐƵƌĨĂĐĞĂƌĞĂ
hE
ďůŽŽĚƵƌĞĂŶŝƚƌŽŐĞŶ
^D
ůŝŶŝĐĂůƌƵŐ^ƵƉƉůǇDĂŶĂŐĞŵĞŶƚ
E^
ĐĞŶƚƌĂůŶĞƌǀŽƵƐƐǇƐƚĞŵ
d
ĐŽŵƉƵƚĞƌŝǌĞĚƚŽŵŽŐƌĂƉŚǇ
/>/
ƌƵŐͲ/ŶĚƵĐĞĚ>ŝǀĞƌǇ/ŶũƵƌǇ
^hZ
ĞǀĞůŽƉŵĞŶƚ^ĂĨĞƚǇhƉĚĂƚĞZĞƉŽƌƚ
K'
ĂƐƚĞƌŶŽŽƉĞƌĂƚŝǀĞKŶĐŽůŽŐǇ'ƌŽƵƉ
W
ĞǆƚĞŵƉŽƌĂŶĞŽƵƐĚŽƐĞƉƌĞƉĂƌĂƚŝŽŶ
ĞZ&
ĞůĞĐƚƌŽŶŝĐĂƐĞZĞƉŽƌƚ&Žƌŵ

ĞůĞĐƚƌŽŶŝĐĚĂƚĂĐĂƉƚƵƌĞ
Kd
ŶĚŽĨdƌĞĂƚŵĞŶƚ
/DW
/ŶǀĞƐƚŝŐĂƚŝŽŶĂůDĞĚŝĐŝŶĂůWƌŽĚƵĐƚ
/EZ
ŝŶƚĞƌŶĂƚŝŽŶĂůŶŽƌŵĂůŝǌĞĚƌĂƚŝŽ
/Zd
/ŶƚĞƌĂĐƚŝǀĞZĞƐƉŽŶƐĞdĞĐŚŶŽůŽŐǇ
/s
ŝŶƚƌĂǀĞŶŽƵƐůǇͬŝŶƚƌĂǀĞŶŽƵƐ
DĞĚZ
DĞĚŝĐĂůŝĐƚŝŽŶĂƌǇĨŽƌZĞŐƵůĂƚŽƌǇĐƚŝǀŝƚŝĞƐ
DZ/
ŵĂŐŶĞƚŝĐƌĞƐŽŶĂŶĐĞŝŵĂŐŝŶŐ
EE
EĂƚŝŽŶĂůŽŵƉƌĞŚĞŶƐŝǀĞĂŶĐĞƌEĞƚǁŽƌŬ
E^/
ŶŽŶͲƐƚĞƌŽŝĚĂůĂŶƚŝͲŝŶĨůĂŵŵĂƚŽƌǇĚƌƵŐ
Wdd
ƉĂƌƚŝĂůƚŚƌŽŵďŽƉůĂƐƚŝŶƚŝŵĞ
Wd
ƉƌŽƚŚƌŽŵďŝŶƚŝŵĞ
WĂŐĞϲϱŽĨϳϬ


Ɖ͘Ϯϵ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Z
ƌĞĚďůŽŽĚĐĞůů
Z^/
ZĞĨĞƌĞŶĐĞ^ĂĨĞƚǇ/ŶĨŽƌŵĂƚŝŽŶ
^
ƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚ
^K
^ǇƐƚĞŵKƌŐĂŶůĂƐƐ
^W&
ƐƵŶƉƌŽƚĞĐƚŝŽŶĨĂĐƚŽƌ
^h^Z
^ƵƐƉĞĐƚĞĚhŶĞǆƉĞĐƚĞĚ^ĞƌŝŽƵƐĚǀĞƌƐĞZĞĂĐƚŝŽŶƐ
dD
dŚĞƌĂƉĞƵƚŝĐƌĞĂDĞĚŝĐĂůŝƌĞĐƚŽƌ
d>
ƚŽƚĂůďŝůŝƌƵďŝŶ
d
ƚƌĞĂƚŵĞŶƚͲĞŵĞƌŐĞŶƚĂĚǀĞƌƐĞĞǀĞŶƚ
h>E
hƉƉĞƌ>ŝŵŝƚŽĨEŽƌŵĂů
WĂŐĞϲϲŽĨϳϬ


Ɖ͘ϯϬ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX B. PERFORMANCE STATUS SCALES CONVERSION
ECOG
Karnofsky
Score
Description
Percent
Description
Ϭ
EŽƌŵĂůĂĐƚŝǀŝƚǇ͘&ƵůůǇĂĐƚŝǀĞ͕ĂďůĞƚŽĐĂƌƌǇŽŶ
ĂůůƉƌĞͲĚŝƐĞĂƐĞƉĞƌĨŽƌŵĂŶĐĞǁŝƚŚŽƵƚ
ƌĞƐƚƌŝĐƚŝŽŶ͘
ϭϬϬ
EŽƌŵĂů͕ŶŽĐŽŵƉůĂŝŶƚƐ͕ŶŽĞǀŝĚĞŶĐĞŽĨ
ĚŝƐĞĂƐĞ͘
ϵϬ
ďůĞƚŽĐĂƌƌǇŽŶŶŽƌŵĂůĂĐƚŝǀŝƚǇ͖ŵŝŶŽƌ
ƐŝŐŶƐŽƌƐǇŵƉƚŽŵƐŽĨĚŝƐĞĂƐĞ͘
ϭ
^ǇŵƉƚŽŵƐ͕ďƵƚĂŵďƵůĂƚŽƌǇ͘ZĞƐƚƌŝĐƚĞĚŝŶ
ƉŚǇƐŝĐĂůůǇƐƚƌĞŶƵŽƵƐĂĐƚŝǀŝƚǇ͕ďƵƚĂŵďƵůĂƚŽƌǇ
ĂŶĚĂďůĞƚŽĐĂƌƌǇŽƵƚǁŽƌŬŽĨĂůŝŐŚƚŽƌ
ƐĞĚĞŶƚĂƌǇŶĂƚƵƌĞ;Ğ͘Ő͕͘ůŝŐŚƚŚŽƵƐĞǁŽƌŬ͕
ŽĨĨŝĐĞǁŽƌŬͿ͘
ϴϬ
EŽƌŵĂůĂĐƚŝǀŝƚǇǁŝƚŚĞĨĨŽƌƚ͖ƐŽŵĞƐŝŐŶƐŽƌ
ƐǇŵƉƚŽŵƐŽĨĚŝƐĞĂƐĞ͘
ϳϬ
ĂƌĞƐĨŽƌƐĞůĨ͕ƵŶĂďůĞƚŽĐĂƌƌǇŽŶŶŽƌŵĂů
ĂĐƚŝǀŝƚǇŽƌƚŽĚŽĂĐƚŝǀĞǁŽƌŬ͘
Ϯ
/ŶďĞĚфϱϬйŽĨƚŚĞƚŝŵĞ͘ŵďƵůĂƚŽƌǇĂŶĚ
ĐĂƉĂďůĞ ŽĨĂůůƐĞůĨͲĐĂƌĞ͕ďƵƚƵŶĂďůĞƚŽĐĂƌƌǇ
ŽƵƚĂŶǇǁŽƌŬĂĐƚŝǀŝƚŝĞƐ͘hƉĂŶĚĂďŽƵƚŵŽƌĞ
ƚŚĂŶϱϬйŽĨǁĂŬŝŶŐŚŽƵƌƐ͘
ϲϬ
ZĞƋƵŝƌĞƐŽĐĐĂƐŝŽŶĂůĂƐƐŝƐƚĂŶĐĞ͕ďƵƚŝƐĂďůĞ
ƚŽĐĂƌĞĨŽƌŵŽƐƚŽĨŚŝƐͬŚĞƌŶĞĞĚƐ͘
ϱϬ
ZĞƋƵŝƌĞƐĐŽŶƐŝĚĞƌĂďůĞĂƐƐŝƐƚĂŶĐĞĂŶĚ
ĨƌĞƋƵĞŶƚŵĞĚŝĐĂůĐĂƌĞ͘
ϯ
/ŶďĞĚхϱϬйŽĨƚŚĞƚŝŵĞ͘ĂƉĂďůĞŽĨŽŶůǇ
ůŝŵŝƚĞĚƐĞůĨͲĐĂƌĞ͕ĐŽŶĨŝŶĞĚƚŽďĞĚŽƌĐŚĂŝƌ
ŵŽƌĞƚŚĂŶϱϬйŽĨǁĂŬŝŶŐŚŽƵƌƐ͘
ϰϬ
ŝƐĂďůĞĚ͕ƌĞƋƵŝƌĞƐƐƉĞĐŝĂůĐĂƌĞĂŶĚ
ĂƐƐŝƐƚĂŶĐĞ͘
ϯϬ
^ĞǀĞƌĞůǇĚŝƐĂďůĞĚ͕ŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ
ŝŶĚŝĐĂƚĞĚ͘ĞĂƚŚŶŽƚŝŵŵŝŶĞŶƚ͘
ϰ
ϭϬϬйďĞĚƌŝĚĚĞŶ͘ŽŵƉůĞƚĞůǇĚŝƐĂďůĞĚ͘
ĂŶŶŽƚĐĂƌƌǇŽŶĂŶǇƐĞůĨͲĐĂƌĞ͘dŽƚĂůůǇ
ĐŽŶĨŝŶĞĚƚŽďĞĚŽƌĐŚĂŝƌ͘
ϮϬ
sĞƌǇƐŝĐŬ͕ŚŽƐƉŝƚĂůŝǌĂƚŝŽŶŝŶĚŝĐĂƚĞĚ͘ĞĂƚŚ
ŶŽƚŝŵŵŝŶĞŶƚ͘
ϭϬ
DŽƌŝďƵŶĚ͕ĨĂƚĂůƉƌŽĐĞƐƐĞƐƉƌŽŐƌĞƐƐŝŶŐ
ƌĂƉŝĚůǇ͘
ϱ
ĞĂĚ͘
Ϭ
ĞĂĚ͘
WĂŐĞϲϳŽĨϳϬ


Ɖ͘ϯϭ ŽĨϯϭ
KWZd/KE^DEh>&KZ>/E/>^dhzWZKdKK>DϭϲͲϮϵϭsĞƌƐŝŽŶϰ͘Ϭ
KE&/Ed/>/E&KZDd/KE
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX C. FLUID RETENTION QUESTIONNAIRE EXAMPLE
^ƵďũĞĐƚ/͗ͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺͺ
KǀĞƌƚŚĞƉĂƐƚϳĚĂǇƐ͕ŽƌƐŝŶĐĞƚŚĞůĂƐƚƚŝŵĞƚŚŝƐƋƵĞƐƚŝŽŶŶĂŝƌĞǁĂƐĐŽŵƉůĞƚĞĚ͗
ϭ͘
tŚĂƚŚĂƐǇŽƵƌĚĂŝůǇǁĞŝŐŚƚďĞĞŶ͍
•
WůĞĂƐĞǁĞŝŐŚǇŽƵƌƐĞůĨĂƚƚŚĞƐĂŵĞƚŝŵĞĞĂĐŚĚĂǇĂŶĚƌĞĐŽƌĚƚŚĞĚĂƚĞĂŶĚǇŽƵƌǁĞŝŐŚƚĨŽƌ
ƚŚĂƚĚĂǇďĞůŽǁ͘tĞŝŐŚƚƐŚŽƵůĚďĞƚĂŬĞŶǁŝƚŚŽƵƚŽƵƚĞƌŐĂƌŵĞŶƚƐƐƵĐŚĂƐŚĂƚƐ͕ĐŽĂƚƐŽƌ
ƐŚŽĞƐ͘DĞĂƐƵƌĞŵĞŶƚƐǁŚŝůĞŝŶůŝŐŚƚŝŶĚŽŽƌĐůŽƚŚŝŶŐŽŶůǇ͕ŽƌƵŶĚĞƌŐĂƌŵĞŶƚƐŽŶůǇ͕ĂƌĞ
ĂĐĐĞƉƚĂďůĞ͖ŚŽǁĞǀĞƌ͕ƉůĞĂƐĞƚƌǇƚŽƵƐĞƚŚĞƐĂŵĞŽƌƐŝŵŝůĂƌĐůŽƚŚŝŶŐ;ŝŶĐůƵĚŝŶŐĂŶǇ
ĂĐĐĞƐƐŽƌŝĞƐŽƌũĞǁĞůƌǇͿĨƌŽŵĚĂǇƚŽĚĂǇǁŚĞŶŵĞĂƐƵƌŝŶŐǁĞŝŐŚƚ͘
•
WůĞĂƐĞĐŽŵƉůĞƚĞŽŶĞƋƵĞƐƚŝŽŶŶĂŝƌĞĨŽƌĞǀĞƌǇϳĚĂǇͬϭǁĞĞŬƉĞƌŝŽĚ͘
Date (DD/MMM/YYYY)
Weight (Circle One:  lb or kg)
ůďŽƌŬŐ
ůďŽƌŬŐ
ůďŽƌŬŐ
ůďŽƌŬŐ
ůďŽƌŬŐ
ůďŽƌŬŐ
ůďŽƌŬŐ
Ϯ͘
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