Clinical trial NCT02620020
Conditions: Low Back Pain
Sponsor: Regeneron Pharmaceuticals
Start date: 2016-01-26; Completion date: 2017-09-13
Enrollment: 563 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).

Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:

* Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score
* Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score
* Change from baseline in the average daily LBPI NRS score

Detailed description:

Arms: arm 1: Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. arm 2: Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. arm 3: Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. arm 4: Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
Interventions: intervention 1: Fasinumab intervention 2: placebo
Intervention descriptions: intervention 1: Participants received fasinumab SC or IV, Q4W or Q8W. intervention 2: Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 


Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................5 
1. 
OVERVIEW .................................................................................................................7 
1.1. 
Study Objectives ...........................................................................................................8 
1.1.1. 
Primary Objective .........................................................................................................8 
1.1.2. 
Secondary Objectives ...................................................................................................8 
1.1.3. 
Safety Objectives ..........................................................................................................8 
1.1.4. 
Other Objectives ...........................................................................................................9 
1.1.5. 
Modifications from the Statistical Section in the Final Protocol ..................................9 
1.1.6. 
Revision History for SAP Amendments .......................................................................9 
2. 
INVESTIGATION PLAN ..........................................................................................10 
2.1. 
Study Design and Randomization ..............................................................................10 
2.2. 
Sample Size and Power Considerations .....................................................................10 
2.3. 
Study Plan ...................................................................................................................11 
3. 
ANALYSIS POPULATIONS ....................................................................................12 
3.1. 
The Modified Intent to Treat Set (mITT) ...................................................................12 
3.2. 
The Full Analysis Set (FAS) .......................................................................................12 
3.3. 
The Safety Analysis Set (SAF) ...................................................................................12 
3.4. 
The PK Analysis Set ...................................................................................................12 
3.5. 
The Anti-Drug Antibody Analysis Set .......................................................................12 
4. 
ANALYSIS VARIABLES .........................................................................................13 
4.1. 
Demographic and Baseline Characteristics ................................................................13 
4.2. 
Medical History ..........................................................................................................13 
4.3. 
Pre-Treatment / Concomitant Medication ..................................................................13 
4.4. 
Efficacy Variable ........................................................................................................14 
4.4.1. 
Primary Efficacy Variable ..........................................................................................14 
4.4.2. 
Secondary Efficacy Variable(s) ..................................................................................15 
4.4.3. 
Exploratory Variable(s) ..............................................................................................15 
4.5. 
Safety Variables ..........................................................................................................15 
4.5.1. 
Adverse Events and Serious Adverse Events .............................................................16 
4.5.2. 
Adverse Events of Special Interest .............................................................................16 
4.5.3. 
Laboratory Safety Variables .......................................................................................16 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
4.5.4. 
Vital Signs ..................................................................................................................17 
4.5.5. 
12-Lead Electrocardiography (ECG) ..........................................................................17 
4.5.6. 
Orthostatic Hypotension .............................................................................................17 
4.5.7. 
Physical Examination Variables .................................................................................18 
4.5.8. 
Neurological Examination Variables ..........................................................................18 
4.5.9. 
Other Safety Variables ................................................................................................18 
4.6. 
Anti-Drug Antibody (ADA) Variables .......................................................................18 
4.7. 
Pharmacokinetic Variables .........................................................................................19 
The PK variable is the serum concentration of fasinumab at scheduled time points. ...................19 
5. 
STATISTICAL METHODS .......................................................................................20 
5.1. 
Demographics and Baseline Characteristics ...............................................................20 
5.2. 
Medical History ..........................................................................................................20 
5.3. 
Prior/Concomitant Medications  .................................................................................20 
5.4. 
Prohibited Medications ...............................................................................................21 
5.5. 
Patient Disposition ......................................................................................................21 
5.6. 
Extent of Study Treatment Exposure and Compliance ...............................................21 
5.6.1. 
Measurement of Treatment Compliance ....................................................................21 
5.6.2. 
Exposure to Investigational product ...........................................................................21 
5.7. 
Analyses of Efficacy Variables ..................................................................................22 
5.7.1. 
Analysis of Primary Efficacy Variable(s) ...................................................................22 
5.7.2. 
Analysis of Secondary Efficacy Variables .................................................................24 
5.7.3. 
Analysis of Exploratory Variables ..............................................................................24 
5.8. 
Analysis of Safety Data ..............................................................................................24 
5.8.1. 
Adverse Events ...........................................................................................................25 
5.8.2. 
Analysis of Adverse Events of Special Interest ..........................................................27 
5.8.3. 
Total Joint Replacments (TJRs) ..................................................................................27 
5.8.4. 
Clinical Laboratory Measurements.............................................................................27 
5.8.5. 
Analysis of Vital Signs ...............................................................................................27 
5.8.6. 
Analysis of 12-Lead ECG ...........................................................................................27 
5.8.7. 
Physical Exams ...........................................................................................................28 
5.8.8. 
Analysis Other Safety Variables .................................................................................28 
5.9. 
Analysis of Pharmacokinetic and Antibody Data .......................................................28 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
5.9.1. 
Analysis of Pharmacokinetic Data ..............................................................................28 
5.9.2. 
Analysis of Anti-drug Antibody Data .........................................................................28 
6. 
DATA CONVENTIONS ............................................................................................29 
6.1. 
Definition of Baseline for Efficacy/Safety Variables .................................................29 
6.2. 
Data Handling Convention for repeat measurements .................................................29 
6.3. 
Data Handling Convention for Missing Data .............................................................29 
6.4. 
Data handling for the SF-36 instrument. ....................................................................31 
6.5. 
Visit Windows ............................................................................................................31 
6.6. 
Unscheduled Assessments ..........................................................................................32 
6.7. 
Pooling of Centers for Statistical Analyses ................................................................32 
7. 
INTERIM ANALYSIS ...............................................................................................33 
8. 
SOFTWARE ...............................................................................................................34 
9. 
REFERENCES ...........................................................................................................35 
10. 
APPENDIX.................................................................................................................36 
10.1. 
Schedule of Time and Events .....................................................................................36 
10.2.
Criteria for Potentially Clinically Significant Values (PCSV) ...................................43 
LIST OF TABLES 
Table 1 Schedule of Events – Screening and Treatment Periods ..................................................36 
Table 2 Schedule of Events – Follow-up  Period ..........................................................................40 
Table 3 Schedule of Events – Follow-up for Patients who undergo Total Joint 
Replacement Surgery ..................................................................................................42 
LIST OF FIGURES 
Figure 1 Study Flow Diagram........................................................................................................10 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
ADA
Anti-drug antibody
AE
Adverse event
AESI
Adverse event of special interest
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical
Clast
Concentration corresponding to tlast
Cmax
Maximum observed drug concentration
Ctrough
Concentration measured at the end of a dosing interval at steady state (taken
directly before next administration)
CMH
Cochran-Mantel-Haenszel
ECG
Electrocardiogram
eCRF
Electronic case report form
EDC
Electronic data capture
EOS
End of Study
EOT
End of Treatment
EQ-5D-5L
EuroQol Group Questionnaire
FAS
Full analysis set
FDA
Food and Drug Administration
HbA1c
Hemoglobin A1c
ICF
Informed consent form
ICH
International Conference on Harmonization
IV
Intravenous
IVRS
Interactive Voice Response System
K-L
Kellgren-Lawrence
LBP
Lower Back Pain
LBPI NRS
Lower Back Pain Intensity Numerical Rating Scale
LS
Least-Squares
MCII
Minimum Clinical Important Improvement
MedDRA
Medical Dictionary for Regulatory Activities
MMRM
Mixed-effect model repeated measures
MNAR
Missing not-at-random
MOS-Sleep
Medical Outcomes Study-Sleep scale
MRI
Magnetic resonance imaging
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
NGF
Nerve growth factor
NRS
Numeric Rating Scale
NSAIDs
Nonsteroidal anti-inflammatory drugs
OA
Osteoarthritis
PCSV
Potentially clinically significant value
PGA
Patient Global Assessment
PK
Pharmacokinetic
PPS
Per protocol set
PT
Preferred term
Q1
First Quartile
Q3
Third Quartile
Q4W
Every 4 (weeks)
Q8W
Every 8 (weeks)
RBC
Red blood cell
Regeneron
Regeneron Pharmaceuticals, Inc.
RMDQ
Roland Morris Disability Questionnaire
SAE
Serious adverse event
SAF
Safety analysis set
SAP
Statistical analysis plan
SAS
Statistical Analysis System
SC
Subcutaneous
SD
Standard Deviation
SE
Standard Error
SF-36
Short Form (36) Health Survey
SOC
System organ class
TEAE
Treatment-emergent adverse event
TJR
Total joint replacement
tlast
Time of the last measurable (positive) drug concentration
TrkA
Tyrosine kinase type 1
ULN
Upper limit of normal
WBC
White blood cell
WHO
World Health Organization
WHODD
World Health Organization Drug Dictionary
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
1.
OVERVIEW 
This Statistical Analysis Plan (SAP) is intended to be a detailed description (expanding on the 
statistical analyses described in the protocol) of the definitions and statistical techniques to be 
used for the analyses of data collected in the R475-PN-1524 study. This SAP will be finalized 
prior to database lock to ensure the credibility of the study results by pre-specifying the statistical 
methods for the data analyses before unblinding of treatment assignments.   
This plan may be revised during the study to accommodate protocol amendments and adapt to 
unexpected issues in study execution that may affect planned analyses.  
Background/Rationale 
This randomized, double-blind, multi-dose, placebo-controlled study is designed to evaluate the 
safety and efficacy of fasinumab in patients with moderate to severe chronic non-radicular LBP 
who have a history of intolerance or inadequate pain relief from paracetamol/acetaminophen and 
at least one oral NSAID and at least one opioid. This subset of patients with chronic LBP 
represents a patient population with an unmet medical need in whom it would be appropriate to 
prospectively study the hypothesis that fasinumab provides benefit and has an acceptable safety 
profile. 
Dose selection for this multiple-dose study in patients with chronic non-radicular LBP is based 
on data from 2 completed fasinumab phase 1 studies in healthy subjects (studies R475-PN-0817 
and TDU-11480), as well as data from the completed fasinumab phase 2 proof-of-concept study 
in patients with pain due to OA of the knee (study R475-PN-0901), and the single-dose proof-of-
concept study in patients with sciatic pain (study R475-PN-0908), the dose-range evaluated in an 
ongoing fasinumab phase 2 study in patients with OA of the knee or hip (study R475-PN-1227), 
and pharmacokinetic (PK) simulations. 
Single SC doses of fasinumab up to 30 mg were well tolerated in healthy male and female 
subjects (study TDU-11480). Single IV doses of up to 1 mg/kg were also studied in healthy male 
and female subjects (study R475-PN-0817). In this study, fasinumab was generally well tolerated 
at all but the highest IV dose (1 mg/kg). Neurosensory AEs, which were transient and not severe, 
led to expansion of the 1 mg/kg IV cohort and a decision to not dose-escalate beyond this level. 
In the phase 2 proof-of-concept study of fasinumab in patients with pain due to OA of the knee, 
multiple IV doses of up to 0.3 mg/kg demonstrated efficacy with regard to pain relief and were 
well tolerated in Caucasian subjects with pain due to OA of the knee. The phase 2 study in 
patients with pain due to OA of the knee or hip (R475-PN-1227) evaluated the efficacy and 
safety of 1, 3, 6, and 9 mg of fasinumab SC every 4 weeks (Q4W).  
Results from completed studies evaluating tanezumab in patients with chronic LBP and in 
patients with pain due to OA indicate that the lowest dose studied may not be adequate to 
demonstrate efficacy in subjects with non-radicular chronic low back pain. This fasinumab study 
will therefore evaluate the 2 highest SC doses that were evaluated in the  recently completed 
study (R475-PN-1227) in OA patients (6 mg and 9 mg SC Q4W) and also includes a 9 mg IV 
fasinumab dose to allow PK, efficacy, and safety comparisons. For patients randomized to SC 
administration, a loading dose equivalent to 2 times the maintenance dose will be administered 
on day 1 to achieve steady state concentrations sooner. This approach is supported by PK 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
simulations based on completed fasinumab studies. 
The U.S. Food and Drug Administration (FDA) placed the study on partial clinical hold before 
enrollment was completed and dosing was prematurely terminated before all randomized patients 
had completed treatment. The study was enrolling patients with chronic low back pain, some of 
whom had advanced osteoarthritis, to doses that exceeded those being pursued in the concurrent 
or planned osteoarthritis studies which limits dosing to 6 mg SC Q8W. Since an event of 
adjudicated arthropathy was observed in the CLBP study in a patient with advanced OA using a 
dose higher than that being evaluated in the ongoing OA study, the FDA requested that the study 
be placed on hold until the protocol could be amended to either remove patients with OA or 
reduce the doses. A decision was made not to amend the protocol to enable dosing to be 
resumed.  At the time of the clinical hold, 563 patients had been randomized into the study. 
Patients will be encouraged to remain in the study and be followed for all study visits until 
completion of the week 36 visit to continue to monitor safety and to allow complete data 
collection.  
The planned analyses take this change into account. 
1.1.
Study Objectives  
1.1.1.
Primary Objective 
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo 
in reducing LBP, as measured by the change from baseline to week 16 in the average daily LBPI 
NRS Score. 
1.1.2.
Secondary Objectives 
Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo 
in treating LBP as measured by: 
x
Change from baseline to week 16 in the RMDQ total score 
x
Change from baseline to week 16 in the PGA of LBP score 
x
Change from baseline to week 2, 4, 8, and 12 in the average daily LBPI NRS score 
1.1.3.
Safety Objectives 
Safety objectives of the study are: 
x
To assess the safety and tolerability of fasinumab compared with placebo in patients with 
LBP by evaluating: 
−
The percent of patients reporting treatment-emergent adverse events (TEAEs) 
−
The percent of patients experiencing clinically significant changes in vital signs, 
physical exams, laboratory safety tests, and electrocardiograms (ECGs) 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
x
To assess the incidence of anti-fasinumab antibody formation 
1.1.4.
Other Objectives 
Exploratory objectives of the study are: 
x
To evaluate the efficacy of fasinumab compared to placebo, as measured by the 
percentage of patients who are responders defined by 30% reduction and 50% reduction 
from baseline to week 16 for: 
−
Average daily LBPI NRS score 
−
RMDQ total score 
−
PGA of LBP score 
x
To evaluate the efficacy of fasinumab compared to placebo, as measured by the change 
from baseline to week 16 in the Medical Outcomes Study (MOS) sleep subscale score 
x
To evaluate the efficacy of fasinumab compared to placebo, as measured by the change 
from baseline to week 16 in the Short Form (36) Health Survey (SF-36) subscale scores 
x
To evaluate the efficacy of fasinumab compared to placebo, as measured by the change 
from baseline to week 16 in the EuroQol 5 Dimensions 5 Levels Questionnaire (EQ-5D-
5L) 
x
To evaluate the efficacy of fasinumab compared to placebo, as measured by the 
percentage of patients who use rescue medication for LBP at week 16 
x
To characterize the PK profile of fasinumab 
1.1.5.
Modifications from the Statistical Section in the Final Protocol 
This SAP is based on Protocol R475-PN-1524 Amendment 3. 
1.1.6.
Revision History for SAP Amendments 
None. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
2.3.
Study Plan 
Study assessments and procedures are presented by study period and visit in Appendix 10.1 
Table 1 and Table 2. A schedule for follow-up on TJR surgery during the study is presented in 
Appendix 10.1 Table 3.
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
3.
ANALYSIS POPULATIONS 
In accordance with guidance from the International Conference of Harmonization of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline ICH E9 
Statistical Principles for Clinical Trials (1998), the following population of analysis will be used 
for all statistical analysis: 
3.1.
The Modified Intent to Treat Set (mITT) 
The modified intent to treat set (mITT) includes all randomized patients per IVRS who received 
at least one dose of study drug based on the treatment allocated (as randomized) including data 
up to 5 weeks after the last dose of study drug.  
3.2.
The Full Analysis Set (FAS) 
The full analysis set (FAS) includes all randomized patients per IVRS and it is based on the 
treatment allocated (as randomized). The FAS will be used to perform sensitivity analysis for the 
primary and selected secondary endpoints. 
3.3.
The Safety Analysis Set (SAF) 
The safety analysis set (SAF) includes all randomized patients who received any study drug; it is 
based on the treatment received (as treated).  
Patients randomized to the ‘Placebo SC Q4W and Placebo 9mg IV Q8W” treatment arm who 
receive at least one dose of active treatment will be classified in the active treatment group in the 
SAF. Patients randomized to any of the treatment groups receiving active fasinumab doses who 
wrongly receive another dose of fasinumab will be classified to the arm of the lowest dose of 
fasinumab received.  For example a patient randomized to the ‘Fasinumab 9mg SC Q4W and 
placebo 9mg IV Q8W’ who wrongly receives treatment with fasinumab 6mg SC at least once 
will be classified under the ‘Fasinumab 6mg SC Q4W and placebo 9mg IV Q8W’ treatment arm. 
Treatment compliance/administration and all clinical safety variables will be analyzed using the 
SAF. 
3.4.
The PK Analysis Set 
The PK analysis set includes all randomized patients who received any study drug and have at 
least 1 qualified (non-missing) blood sample following the first administration of study drug; it is 
based on the treatment received (as treated). 
3.5.
The Anti-Drug Antibody Analysis Set 
The anti-drug (fasinumab) antibody (ADA) analysis will include all randomized and treated 
patients who have at least 1 post-dose ADA result after the first dose of study treatment. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
4.
ANALYSIS VARIABLES 
4.1.
Demographic and Baseline Characteristics 
Baseline characteristics will include standard demography (e.g., age, gender, race, ethnicity, 
weight, height, etc.), disease characteristics including baseline LBPI NRS score, duration of 
chronic back pain, maximum K-L score at any knee or hip joint at screening, use of 
paracetamol/acetaminophen as rescue medication during the pre-randomization period, medical 
history, and medication history for each patient. 
The following demographic and baseline characteristic variables will be summarized by 
treatment group based on data collected in the eCRF:  
x
Age at screening (years) 
x
Age category based on tertiles.  
x
Age category (<65, >=65 years)  
x
Sex (Male, Female) 
x
Race (American Indian/Alaskan Native, Asian, Black/African American, Native 
Hawaiian/Other Pacific Islander, White and Other) 
x
Ethnicity (Hispanic/Latino: Yes or No) 
x
Baseline Weight(kg) 
x
Baseline Height(cm) 
x
Baseline Body mass index (BMI) calculated from weight and height
x
Baseline LBPI NRS score 
x
Baseline LBPI NRS score strata (< 7, ≥ 7) 
x
Duration of chronic back pain (years)
x
Duration of chronic back pain strata (< 5 years, ≥ 5 years)
x
Maximum Kellgren-Lawrence score at any knee or hip joint at screening
x
Maximum Kellgren-Lawrence score at any knee or hip joint at screening (≤2, >2)
x
Use of rescue medication during pre-treatment period (Paracetamol/Acetaminophen: 
Yes or No) 
Additional baseline characteristics will be summarized if needed. 
4.2.
Medical History 
Patient medical history will be dictionary coded by Preferred Term (PT) and associated Primary 
System Organ Class (SOC) according to the MedDRA version 18.0. 
4.3.
Pre-Treatment / Concomitant Medication 
Medications and procedures will be recorded from the day of informed consent until the EOS 
visit. Medications will be coded to the ATC level 2 (therapeutic main group) and ATC level 4 
(chemical/therapeutic subgroup), according to the WHO Drug Dictionary (WHODD) March 
2015 version. Prior medications are defined as medications starting prior to the first 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
administration of study drug. Prior procedures are defined as procedures performed prior to the 
first administration of study drug.  
Concomitant medications are defined as medications starting prior to or during the on-treatment 
period (as defined in section 4.5) and ending during or after the on-treatment period.  
Post treatment medications are medications starting after the on-treatment period. 
Prohibited medications include medications containing NSAIDS (oral or topical; except up to 
100mg/day of aspirin for cardiac prophylaxis) and opioid analgesic medications (including 
tramadol). Opioid analgesic medications (including tramadol) are prohibited through the week 16 
study visit.  Patients will be directed not to take concomitant medications that contain NSAIDS 
(oral or topical, except up to 100mg/day of aspirin, which is permitted for cardiac prophylaxis) 
until at least 16 weeks after the last dose of study drug. Other excluded drugs include: 
x
Any other investigational agent 
x
Cyclosporine 
x
Azathioprine 
x
Medical marijuana 
x
Tumor necrosis factor antagonists
x
Corticosteroids (topical and inhaled formulations are permitted) 
x
Tocilizumab 
x
Abatacept 
x
Cyclobenzaprine, carisoprodol, orphenadrine, tizanidine 
x
Muscle relaxants 
Prohibited concomitant medications will be summarized separately by ATC class, preferred term 
and treatment group.  
Patients will be counted once in all ATC categories linked to the medication. 
4.4.
Efficacy Variable 
4.4.1.
Primary Efficacy Variable 
The primary endpoint in the study is the change from baseline to week 16 in the average daily 
Low Back Pain Intensity (LBPI) score on an 11-point (0-10) Numerical Rating Scale (NRS).
Baseline average daily LBPI NRS score is defined as the average of the non-missing daily LBPI 
NRS scores for 5 days prior to randomization (from Day -4 to Day 1).  Average daily LBPI NRS 
scores is defined as the average of the non-missing daily LBPI NRS scores for the 7days before 
and including nominal visit.  The daily NRS score for the week 16 nominal visit day is missing 
for all patients due to operational difficulties which resulted in the daily entry not being captured 
on the clinical visit day since diaries are available starting at 6pm and clinical visits typically 
happen during the day with diaries being returned at the end of the visit. Therefore the average at 
week 16 will be based on 6 days.  
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
4.4.2.
Secondary Efficacy Variable(s) 
The secondary endpoints in the study are: 
x
Change from baseline to weeks 2, 4, 8, 12 and 16 in the RMDQ total score 
x
Change from baseline to weeks 2, 4, 8, 12 and 16 in the PGA of LBP score 
x
Change from baseline to weeks 2, 4, 8, and 12 in the LBPI NRS score 
The total score of the Roland Morris Disability Questionnaire (RMDQ) is the total number of 
items checked by the patient (range of 0 to 24, with lower scores indicative of better function).  
The Patient global assessment (PGA) of LBP is a patient assessed 5 point Likert scale of LBP 
(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).  
4.4.3.
Exploratory Variable(s) 
Exploratory endpoints in the study are: 
x
The percentage of patients who are responders defined by 30% reduction and 50% 
reduction from baseline to week 16 in: 
−
Average daily LBPI NRS score 
−
RMDQ total score 
−
PGA of LBP score 
x
Cumulative distribution of percent change from Baseline in average LBPI score to 
Week 16 
x
Cumulative distribution of percent change from Baseline in RMDQ total score to 
Week 16 
x
Change from baseline to weeks 2, 4, 8, 12 and 16 in the MOS-Sleep subscale score 
x
Change from baseline to weeks 2, 4, 8, 12 and 16 in the SF-36 subscale scores 
x
Change from baseline to weeks 2, 4, 8, 12 and 16 in the EQ-5D-5L visual analogue 
scale (VAS) and utility index scores 
x
Usage of rescue medication (percentage of patients who use rescue medication for 
LBP, number of days of usage, and weekly average amount taken during weeks 2, 4, 
8 12, and 16) 
4.5.
Safety Variables 
Patient safety will be assessed through the collection of reported adverse events (AEs), clinical 
laboratory data, vital signs, ECG and physical exam.  
Unless otherwise noted, the baseline value is defined as the last available value before the first 
dose of study treatment. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
4.5.1.
Adverse Events and Serious Adverse Events 
Adverse events and serious adverse events will be collected from the time of informed consent 
signature and then at each visit until the end of the study. All adverse events are to be coded to a 
“Preferred Term (PT)” and associated primary “System Organ Class (SOC)” according to the 
Medical Dictionary for Regulatory Activities (the latest current available version). 
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation 
patient administered a pharmaceutical product and which does not necessarily have to have a 
causal relationship with this treatment. 
A Serious Adverse Event is an adverse event (AE) that is classified as serious according to the 
criteria specified in the protocol.  
Laboratory results, vital signs, or ECG abnormalities are to be recorded as AEs if they are 
medically relevant: symptomatic, requiring corrective therapy, leading to treatment 
discontinuation and/or fulfilling a seriousness criterion. 
4.5.2.
Adverse Events of Special Interest 
Adverse events of special interest (AESI) for the fasinumab program include adjudicated 
arthropathy and sympathetic nervous system dysfunction, as specified in the protocol.  
AESI are selected using e-CRF specific tick box on the AE page. 
4.5.3.
Laboratory Safety Variables 
Clinical laboratory tests will consist of blood analyses (including hematology and clinical 
chemistry) and urinalysis. Clinical laboratory values will be converted and analyzed in 
international units, including associated normal ranges provided by the central laboratory. 
International units will be used in all listings and tables.  
Clinical laboratory values in conventional (US) units will also be available in the database, with 
associated normal ranges (analyses can be provided upon request). Both actual test values and 
“change from baseline” values (defined as the post-baseline value minus the baseline value) will 
be used in the result summaries. Potentially clinically significant values (PCSV) ranges will be 
applied to the laboratory test values as applicable. The following PCSV categories will be used 
for the laboratory PCSV analysis tables:  
x
Red Blood Cells and Platelets 
x
White Blood Cells 
x
Metabolic Function 
x
Electrolytes 
x
Renal Function 
x
Liver Function 
x
Lipid Panel 
x
Urinalysis 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
4.5.4.
Vital Signs 
Vital sign parameters will include temperature, pulse (measured over a 1-minute period), and 
respiratory rate. As well as supine BP, 1 min and 3 min standing BP, supine heart rate, 1 min and 
3 min heart rate which are used in the assessment of orthostatic hypotension. Both actual values 
and “change from baseline” values (defined as the post-baseline value minus the baseline value) 
will be used in the result summaries. Potentially clinically significant values (PCSV) ranges will 
be applied to the vital sign parameter values as applicable (see Appendix 10.2 for PCSV 
definitions). 
4.5.5.
12-Lead Electrocardiography (ECG) 
12-Lead ECG parameters include P-R interval, QT interval, QTc interval including QTcF and 
QTcB, QRS interval, Ventricular rate and Heart rate. 
QTcF and QTcB are defined as follows:  
QTcF (ms) =QT/RR1/3 and  QTcB (ms) =QT/RR1/2  , 
where QT is the uncorrected QT interval measured in ms, and RR is 60/HR with HR being the 
heart rate in beats per minutes. Electrocardiogram assessments will be described as normal or 
abnormal. Potentially clinically significant values (PCSV) ranges will be applied to the ECG 
parameter values as applicable (see Appendix 10.2 for PCSV definitions). 
4.5.6.
Orthostatic Hypotension 
A patient will be determined to have orthostatic hypotension if any of the following criteria are 
met: 
x
If the supine blood pressure is <160 mmHg systolic, a decrease in either the 1 min or 
3 min standing systolic blood pressure of ≥20 mmHg or a decrease in either the 1 min 
or 3 min standing diastolic blood pressure of ≥10 mmHg from the supine systolic or 
diastolic blood pressure 
OR
x
If the supine blood pressure is ≥160 mmHg systolic, a decrease in either the 1 min or 
3 min standing systolic blood pressure of ≥30 mmHg or a decrease in either the 1 min 
or 3 min standing diastolic blood pressure of ≥15 mmHg from the supine systolic or 
diastolic blood pressure 
OR
x
An increase in either 1 min or 3 min standing heart rate of ≥30 bpm from the supine 
heart rate 
OR
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
x
The patient is unable to stand for either one of the standing blood pressure 
measurements due to dizziness or lightheadedness 
4.5.7.
Physical Examination Variables 
Physical exam assessments will be described as normal or abnormal. 
4.5.8.
Neurological Examination Variables 
Neurological evaluations of specific domains as listed in the protocol will be described as normal 
or abnormal.   
4.5.9.
Other Safety Variables 
Survey of Autonomic Symptoms questionnaire: number of patients reporting health symptoms 
during the past 6 months for each symptom/health problem assessed as well the severity of 
symptoms reported at each scheduled visits. 
Joint Pain Questionnaire: number of patients with pain in joints lasting more than 2 weeks at 
each scheduled visits. 
Pregnancy on study will be assessed.  
4.6.
Anti-Drug Antibody (ADA) Variables  
Serum samples collected at baseline, week 16 (end of treatment) and week 36 (end of study) or 
ET (early termination) will be analyzed for anti-drug antibody (ADA) analysis.  ADA variables 
include status (positive or negative) and titer as follows: 
x
Total number of patients whose response in the ADA assay is negative at all times  
x
Total number of patients whose response in the ADA assay is positive at any time 
point analyzed 
x
Pre-existing immunoreactivity - defined either as a positive ADA assay response at 
baseline with all post-dose ADA assay results negative, OR a positive assay response 
at baseline with all post-dose ADA assay responses less than 9-fold over baseline titer 
levels 
x
Treatment-emergent - defined as any post-treatment positive ADA assay response 
when the baseline is ADA negative or missing 
x
Treatment-boosted – defined as any post-dose positive ADA assay response that is at 
least 9-fold over the baseline titer level when baseline is positive in the ADA assay.  
x
Titer 
o
Titer values 
o
Titer category 
−
Low (titer <1,000) 
−
Moderate (1,000≤ titer ≤10,000)
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
−
High (titer >10,000)   
Neutralizing activities of ADA will be assessed for samples that are positive in the ADA assay. 
4.7.
Pharmacokinetic Variables  
The PK variable is the serum concentration of fasinumab at scheduled time points. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
5.
STATISTICAL METHODS 
For continuous variables, descriptive statistics will include the following: the number of patients 
reflected in the calculation (n), mean, standard deviation, median, first quartile (Q1), third 
quartile (Q3), minimum, and maximum. 
For categorical or ordinal data, frequencies and percentages will be displayed for each category. 
5.1.
Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be descriptively summarized by treatment group 
and overall for the study based on the FAS.  Parameters to be summarized include those 
described in Section 4.1 .
Continuous data will be summarized using the number of patients (n), mean, standard deviation, 
median, Q1, Q3, minimum, and maximum. Categorical and ordinal data will be summarized 
using the number and percentage of patients in each treatment group. 
5.2.
Medical History 
Relevant medical histories at study entry will be descriptively summarized by treatment group 
and overall for the study based on the FAS. 
All reported patient’s medical history and surgical history will be presented by primary SOC, PT 
and treatment group. Primary SOCs will be sorted by decreasing frequency in the combined 
fasinumab group. Within each primary SOC, PTs will be sorted by decreasing frequency in the 
combined fasinumab group. 
5.3.
Prior/Concomitant Medications  
All prior medications, dictionary coded by WHO, will be descriptively summarized by ATC 
class, preferred term  and treatment group and overall for the study based on the safety analysis 
set. Summaries will present patient counts (and percentages) for all prior medications in 
decreasing frequency of the overall incidence of ATC followed by therapeutic class.  In case of 
equal frequencies across anatomic or therapeutic categories, alphabetical sorting order will be 
used. Patients will be counted once in each ATC category (anatomic or therapeutic) linked to the 
medication, but may be counted several times for the same medication.   
All concomitant medications, dictionary coded by WHO, will be descriptively summarized by 
ATC class, preferred term and treatment group, for patients in the SAF. Summaries will present 
patient counts (and percentages) for the concomitant medication groups described in Section 4.3
for all concomitant medications, in decreasing frequency of the fasinumab group incidence of 
ATC followed by therapeutic class.  In case of equal frequencies across anatomic or therapeutic 
categories, alphabetical sorting order will be used. Patients will be counted once in each ATC 
category (anatomic or therapeutic) linked to the medication, hence may be counted several times 
for the same medication.    
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
The following will be summarized: 
x
Prior Medications 
x
Concomitant medications 
x
Post-treatment medications 
x
On-study (Concomitant + Post-Treatment) Medications 
5.4.
Prohibited Medications 
Prohibited medications, dictionary coded by WHO, will be descriptively summarized by ATC 
class, preferred term and treatment group for patients in the SAF similar to the summary of 
concomitant medications. 
5.5.
Patient Disposition 
The disposition of patients in the study will summarized by treatment group and overall for all 
patients. The following summaries will be provided:  
Summary of total screened patients, numbers of subjects in FAS, and SAF by treatment and total. 
Summaries of discontinuations from treatment and discontinuations from the study including 
reasons for discontinuation will also be presented by treatment and overall. 
5.6.
Extent of Study Treatment Exposure and Compliance 
5.6.1.
Measurement of Treatment Compliance 
Compliance with protocol-defined investigational product will be calculated based on the safety 
set as follows: 
Treatment compliance will be calculated as:
͓݋݂ܽܿݐݑ݈ܽ݆݅݊݁ܿݐ݅݋݊ݏȀ݂݅݊ݑݏ݅݋݊ݏ݋݂ݏݐݑ݀ݕ݀ݎݑ݃ݎ݁ܿ݅݁ݒ݁݀
݀ݑݎ݅݊݃݁ݔ݌݋ݏݑݎ݁݌݁ݎ݅݋݀
͓݋݂݌݈ܽ݊݊݁݀݆݅݊݁ܿݐ݅݋݊ݏȀ݂݅݊ݑݏ݅݋݊ݏ݋݂ݏݐݑ݀ݕ݀ݑݎ݃݀ݑݎ݅݊݃݁ݔ݌݋ݏݑݎ݁݌݁ݎ݅݋݀
݋݊݋ݎܾ݂݁݋ݎ݁ݐ݄݁ݐ݅݉݁݌ܽݐ݅݁݊ݐ݀݅ݏܿ݋݊ݐ݅݊ݑ݁݀݂ݎ݋݉ݐ݄݁ݐݎ݁ܽݐ݉݁݊ݐ݌݄ܽݏ݁݋݂ݐ݄݁ݏݐݑ݀ݕ
ݔͳͲͲΨ
The loading dose at baseline will not be counted as a separate injection/infusion. The treatment 
compliance will be presented by the descriptive statistics and the number (%) of patients who 
have 1, 2, 3 and 4 SC injections or 1 and 2 IV infusions, respectively. 
5.6.2.
Exposure to Investigational product 
The treatment exposure to fasinumab and placebo SC doses during the study will be presented by 
treatment and calculated as: 
x
(Date of last study drug administration – date of first study drug administration) + 28 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
The treatment exposure to fasinumab and placebo IV doses during the study will be presented by 
treatment and calculated as: 
x
(Date of last study drug administration – date of first study drug administration) + 56 
The duration of exposure during the study will be summarized for each treatment group using  
the number of patients (n), mean, standard deviation, median, Q1, Q3, minimum, and maximum. 
The number (%) of patients with exposure periods will be presented by specific time periods. 
The time periods of interest is specified as: ≥ 1 day, ≥ 8 days, ≥ 15 days, ≥ 29 days, ≥ 57 days, ≥ 
85 days, and ≥ 113 days.
The duration of observation period during the study is calculated as: 
x
(Date of the last study visit – date of the first study drug administration) +1. 
The number (%) of patients with observation periods will be presented by specific time periods. 
The time periods of interest is specified as: ≥ 1 day, ≥ 8 days, ≥ 15 days, ≥ 29 days, ≥ 57 days, ≥ 
85 days, and ≥ 113 days.
A summary of the number of doses by treatment group will be provided. 
5.7.
Analyses of Efficacy Variables 
5.7.1.
Analysis of Primary Efficacy Variable(s) 
The primary endpoint in the study is the change from baseline to week 16 in the average daily 
LBPI NRS score. The following hypotheses will be tested (with no control for multiplicity): 
x
H1:  No difference in the change from baseline to week 16 in the average LBPI NRS 
score for fasinumab 6mg SC Q4W and Placebo.  
x
H2:  No difference in the change from baseline to week 16 in the average LBPI NRS 
score for fasinumab 9mg SC Q4W and Placebo.  
x
H3:  No difference in the change from baseline to week 16 in the average LBPI NRS 
score for fasinumab 9mg IV Q8W and Placebo.  
Statistical Model 
The primary efficacy variable, change from baseline in LBPI score, will be analyzed using a 
mixed-effect model repeated measures (MMRM) approach based on the mITT. The model will 
include the randomization strata, baseline LBPI score, treatment, study week, and treatment-by-
week interaction. Denominator degrees of freedom will be estimated using Kenward-Roger’s 
approximation. Data from all patients, including data collected after discontinuing treatment up 
to the earlier  of withdrawal of consent,  week 16 or 5 weeks after the last dose of study drug, 
will be used in the primary efficacy analyses according to the intent-to-treat principle using the 
MMRM approach with no imputation for missing data.  
The fitting of MMRM will be performed using MIXED procedure in SAS with an unstructured 
covariance matrix to model the within-patient errors. If the model does not converge using 
unstructured covariance matrix, a simpler covariance structure with fewer parameters will be 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
used according  to the following order:  heterogeneous autoregressive (1)ARH(1), Compound 
symmetry (CSH), Toeplitz (TOEP).    
The Least-Squares means estimates for the mean change from baseline to week 16, as well as the 
differences of the estimates between fasinumab doses and placebo, with their corresponding 
standard errors, p-values and associated 95% confidence intervals will be provided from the 
MMRM model. The graph of LS-mean +/- SE by visit will be provided.  In addition, the absolute 
value at week 16 and change from baseline to week 16 in LBPI NRS score will be summarized 
and graphed by visit. 
Sample SAS codes that can be used to implement the MMRM analysis are shown below: 
proc mixed data=LBPI_NRS; 
  class subid trt week stratum1 stratum2 stratum3; 
  model chg = baseline trt stratum1 stratum2 stratum3 week trt*week 
/ddfm = kr; 
  repeated week / type=un subject=subid; 
  lsmeans trt*week/ slice=week pdiff cl; 
run;
Where stratum1, stratum2, and stratum3 are baseline LBPI NRS score (<7, ≥7), duration of 
chronic back pain (<5 years, ≥5 years), and maximum K-L category (≤2, >2). 
Sensitivity analysis:  
Sensitivity analyses will be performed the same way for the primary and secondary variables 
(RMDQ total score and PGA) using the FAS. 
Subgroup analysis: 
Descriptive analyses will be performed on the primary endpoint and the secondary endpoints 
(RMDQ total score and PGA) to summarize the treatment effects across subpopulations defined 
by baseline randomization strata (baseline LBPI NRS score, duration of chronic back pain , and 
maximum K-L score category), demographics (age group, sex, race) and baseline characteristics 
(weight and BMI categories). Subgroup analysis by osteoarthritis (OA) subgroup will be 
performed. OA subgroup is defined as: 
1. Medical History of OA  
2. Kellgren Lawrence Grade ≥ >=2 radiographic evidence of hip or Grade ≥ >=3 
radiographic evidence of knee  
3. Either (1) or (2) 
Subgroup analysis based on other medical conditions may also be performed. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
5.7.2.
Analysis of Secondary Efficacy Variables 
All secondary efficacy variables will be analyzed based on the mITT using the same MMRM as 
described in Section 5.7.1 to compare fasinumab doses with placebo without multiplicity 
adjustment. These models will include fixed effect terms for randomization strata, corresponding 
baseline value, treatment, visit, and treatment-by-visit interaction. LS mean with standard errors, 
LS mean difference with standard error, and its 95 % confidence interval will be provided. The 
graph of LS-mean +/- SE by visit will be provided.  In addition, for each secondary variable,  
absolute value and  change from baseline value will be summarized and graphed by visit. 
5.7.3.
Analysis of Exploratory Variables 
Responder analyses 
The percentage of patients who are responders based on the variables listed in Section 4.5.3 are 
defined by 30% reduction and 50% reduction from baseline to week 16 will be summarized by 
the treatment group. These response-based categorical exploratory variables will be analyzed for 
FAS using the Cochran-Mantel-Haenszel (CMH) test, stratified by the randomization strata.  
Cumulative distribution of percent change from baseline in average daily LBPI score and RMDQ 
total score will be presented by treatment group. The cumulative distribution plot displays a 
continuous plot of the percent change from baseline on the X-axis and the percent of patients 
experiencing that change on the Y-axis. Different responder definitions can be identified along 
the cumulative distribution curve. 
Continuous endpoints 
All continuous exploratory variables will be analyzed for FAS using the same MMRM as 
described in Section 5.7.1 to compare fasinumab doses with placebo without multiplicity 
adjustment. These models will include fixed effect terms for randomization strata, corresponding
baseline value, treatment, visit, and treatment-by-visit interaction. LS mean with standard errors, 
LS mean difference with standard error, and its 95 % confidence interval will be provided. The 
graph of LS-mean +/- SE by visit will be provided.  In addition, each variable, absolute value  
and change from baseline value will be summarized and graphed by visit. 
Rescue Medication 
The percentage of patients who use rescue medication between baseline and week 16 will be 
summarized by the treatment group. The categorical exploratory variable will be analyzed for 
FAS using the Cochran-Mantel-Haenszel (CMH) test, stratified by the randomization strata.  
Number of days patients used rescue medication during the treatment period (Day1 to Week 2, 
Week 2 to Week 4, Week 4 to Week 8, Week 8 to Week 12, Week 12 to Week 16) will be 
summarized descriptively by treatment group. Weekly average amount of rescue medication use 
will be summarized descriptively by treatment group.  
5.8.
Analysis of Safety Data 
The analysis of safety and tolerability will be performed on the SAF, as defined in Section 3.3.
The safety analysis will be based on the reported AEs and other safety information (clinical 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
laboratory evaluations, vital signs, physical exam and 12-lead ECG). Thresholds for Potential 
Clinically Significant Values (PCSV) in laboratory variables, vital signs and ECG are defined in 
Appendix 10.2. 
The summary of safety results will be presented for each treatment group. 
Period of observation: The observation period will be divided into three segments: pre-
treatment, on-treatment, and follow-up period.  
x
The pre-treatment period is defined as the time from signing the ICF to before the first 
dose of study drug.  
x
The on-treatment period is defined as the day from first dose of study drug to 4 weeks 
after the last dose of SC study drug or 8 weeks after the last dose of IV study drug, 
whichever is later.  
x
The Post/Treatment follow-up period is defined as from the end of the on-treatment 
period+1 day to the end of study visit (week 36). 
Unless otherwise noted, summaries of safety variables will use data from the on-treatment 
period. Listings of safety variables will include data from all periods and values occurring during 
the pre-treatment and follow-up period will be flagged in the listings.  
Day 1 is the first day of investigational product, Day –1 is the day before, and there is no Day 0. 
The time interval to detect any on-treatment event or abnormality is the on-treatment period. 
Data collected outside this interval will be excluded from the estimation of descriptive statistics 
and identification of abnormalities for laboratory evaluations, ECGs and vital signs. All post-
baseline data during the interval will be using in the PCSV analysis including scheduled and 
unscheduled assessments. 
5.8.1.
Adverse Events  
The verbatim text, the PT, and the primary SOC will be listed in patient listings. Summaries that 
include frequencies and proportions of patients reporting AEs will include the PTs and the SOCs. 
Pre-treatment AEs are defined as AEs that developed or worsened  during the pre-treatment 
period. 
Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the 
on-treatment period. 
Post-treatment AEs are defined as AEs that developed or worsened more than 28 days after the 
last SC dose of investigational product or 56 days after the last IV dose of investigational 
product.
The focus of adverse event reporting in the clinical study report will be on TEAEs. Post-
treatment AEs and AEs during the combined study periods will also be summarized. 
For details on handling missing data and partial dates, see Section 6.
Summaries of all TEAEs in each treatment group will include: 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
x
Overview of TEAEs, summarizing number of events, summarizing number and 
percentage of patients with any 
−
Total number of TEAEs 
−
Total number of Serious TEAEs 
−
Patients with any TEAEs 
−
Patients with Serious TEAEs 
−
Patients with TEAE leading to permanent treatment discontinuation 
−
Patients with TEAE leading to withdrawal from study 
−
Patients with TEAE leading to death 
−
Patients with any AESI’s
x
TEAEs by SOC and PT 
x
TEAEs by SOC, PT, and severity 
x
Treatment-related TEAEs by SOC, PT, and severity 
x
TEAEs Resulting in Permanent Study Drug Discontinuation by SOC and PT 
x
AESI by SOC and PT 
x
Post-Treatment TEAEs by SOC and PT 
x
Post-Treatment TEAEs by SOC, PT, and severity 
x
All On-Treatment and Post-Treatment AEs by SOC and PT 
x
All On-Treatment and Post-Treatment AEs by SOC, PT, and severity  
x
Serious TEAEs by SOC and PT 
x
Non-serious TEAEs by SOC and PT 
x
Post-treatment Serious AEs by SOC and PT 
x
All Serious AEs by SOC and PT 
x
Listing of Patients with Serious TEAEs 
x
Listing of Patients with AESIs 
x
Listing of deaths 
x
Listing of AEs leading to death 
Counts will be provided by treatment group for each PT within each SOC. Percentages will be 
calculated using the number of patients from the SAF in each treatment group. 
Primary SOCs will be sorted by decreasing frequency of investigational product, with the total 
overall classes coming first and labeled “Any class”. Within each primary SOC, PTs will be 
sorted by decreasing frequency of investigational product. For tables presenting severity of 
events, the worst severity will be chosen for patients with multiple instances of the same event. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
A second type of table with counts of each primary SOC in decreasing order of frequency will be 
provided.  A third type of table with counts of each PT in decreasing order of frequency will also 
be provided. 
Common TEAEs (preferred terms ≥5% in any treatment group) will be summarized in the report. 
5.8.2.
Analysis of Adverse Events of Special Interest 
Treatment emergent adverse events of special interest for adjudicated arthropathy and 
sympathetic nervous system dysfunction will be presented by SOC and PT. The summaries will 
be sorted by decreasing incidence of PT within each SOC in the combined fasinumab group. 
5.8.3.
Total Joint Replacements (TJRs) 
Total and partial joint replacements of any joints will be summarized by treatment group. 
Number of replacements in joints that were positively adjudicated will be summarized by 
treatment group. TJRs will also be summarized by KL score of the affected joint.  
5.8.4.
Clinical Laboratory Measurements  
A treatment-emergent Potential Clinically Significant abnormal value (PCSV) is a laboratory 
value that was normal or abnormal but not meeting PCSV criteria at Screening and Baseline but 
became abnormal and met PCSV criteria after treatment with study drug. PCSV summary will be 
constructed for on-treatment period, post-treatment period and overall during the study. 
Baseline clinical laboratory analytes and change from Baseline in clinical laboratory analytes to 
each scheduled assessment time will be summarized with descriptive statistics. Summary 
statistics will include using the number of patients (n), mean, standard deviation, median, Q1, 
Q3, minimum, and maximum.   Scatter plot of change scores from baseline of LBPI vs. Alkaline 
phosphatase will be plotted by treatment group and visit. Mean change from baseline in Alkaline 
phosphatase values along with standard error bars will be plotted over time by treatment group.  
5.8.5.
Analysis of Vital Signs 
Vital signs (pulse, sitting blood pressures, orthostatic blood pressure/heart rate, and temperature) 
will be summarized by baseline and change from baseline to each scheduled assessment time 
with descriptive statistics.   The graphs of mean (or median) value of some vital sign parameter 
vs. visit will also be plotted. 
PCSV summary including orthostatic hypotension will be constructed for on-treatment period, 
post-treatment period and overall during the study. 
5.8.6.
Analysis of 12-Lead ECG 
ECG parameters (P-R interval, QT interval, QTc interval, QRS interval, Ventricular rate and 
Heart rate) will be summarized by baseline and change from baseline to each scheduled and 
collected assessment time.  PCSV summary of ECG parameters will be provided for on-
treatment period, post-treatment period and overall during the study.    
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
ECG status (i.e. normal, abnormal) will be reported. Newly occurring ECG findings will be 
summarized.  
5.8.7.
Physical Exams 
The percentage of patients with new-onset abnormal physical examinations will be summarized 
using frequency and percentage by body system by visit.. 
5.8.8.
Analysis Other Safety Variables 
Summaries and listings will be provided for the Survey of Autonomic Symptoms and Joint Pain 
Questionnaire. Arthropathy adjudications based on the imaging data will also be summarized.  
5.9.
Analysis of Pharmacokinetic and Antibody Data 
5.9.1.
Analysis of Pharmacokinetic Data  
Summaries of  concentrations  of functional fasinumab will be presented by nominal time point 
and dose. Plots of individual concentration will be presented by actual day (linear and log 
scales).  Plots of mean or median concentration of functional fasinumab will be presented by 
nominal day and visit (linear and log scales). 
5.9.2.
Analysis of Anti-drug Antibody Data  
The ADA variables described in Section 4.6 will be summarized using descriptive statistics by 
dose/cohort group in the ADA analysis set. Prevalence of pre-existing immunogenicity, 
treatment-emergent and treatment-boosted ADA will be assessed as absolute occurrence (N) and 
percent of patients (%), grouped by study cohorts .Plots of drug concentrations will be examined 
and the influence of treatment-emergent or treatment-boosted ADA assay response on individual 
PK profiles will be evaluated.  
Listings of ADA positivity and titers presented by patient, time point, and dose cohort/group will 
also be provided.  
Impact of ADA on Safety and Efficacy 
Correlation analysis of safety versus treatment-emergent ADA positivity status may be 
performed on the SAF. Assessment will focus on the following safety events: 
x
Hypersensitivity (SMQ : Hypersensitivity [Narrow]) 
x
Anaphylaxis (SMQ: Anaphylaxis[Narrow]) 
Number (%) of patients with the above mentioned safety events may be summarized by ADA 
status (positive or negative), during the TEAE period. 
In addition,  correlation analysis of key efficacy endpoints versus treatment-emergent ADA 
status in patients who discontinued due to lack of efficacy may be summarized. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
6.
DATA CONVENTIONS 
The following analysis conventions will be used in the statistical analysis.  
6.1.
Definition of Baseline for Efficacy/Safety Variables 
Unless otherwise specified, the Baseline assessment for all measurements will be the latest 
available valid measurement taken prior to the administration of investigational product. 
6.2.
Data Handling Convention for repeat measurements 
Orthostatic Hypotension data
This applies specifically to the data handling of repeat measurements in the assessment of 
orthostatic hypotension. Per protocol, if the initial vital assessments for orthostatic hypotension is 
consistent with the definition of orthostatic hypotension, the supine, standing blood pressure  or 
pulse should be repeated up to 2 more times. The guidelines for the repeat assessments are 
shown below: 
Initial 
Assessment
Repeat 
Assessment 1
Repeat 
Assessment 2
Does Patient 
meet OH 
criteria
Value to be used 
in the analysis
Does not meet OH 
definition
N/A
N/A
No
Initial
Assessment
Meets OH 
definition - repeat
Does not meet 
definition - repeat
Does not meet 
definition
No
Repeat 
Assessment 2
Meets OH 
definition - repeat
Does not meet 
definition - repeat
Meets OH 
definition
Yes, AE of 
OH reported. 
Repeat 
Assessment 2 
Meets OH 
definition - repeat
Meets OH 
definition
N/A
Yes, AE of 
OH reported. 
Repeat 
Assessment 1 
Baseline for the assessment of orthostatic hypotension vital assessments uses the last available 
assessment prior to the start of study drug.  Measurements post baseline will not be averaged. 
Rather frequency counts for patients meeting criteria for orthostatic hypotension will reflect the 
scenario as shown in the table.   
Patient reported outcomes data
Should there be duplicate data entries for PRO ediary data, the first entry for the day will be 
used. 
6.3.
Data Handling Convention for Missing Data 
Missing/Incomplete AE/Concomitant medication dates 
Imputation of AE and Concomitant Missing and Partial start dates: 
Every effort will be made to collect the start dates of all AEs and concomitant medications.  
However, in the case the start date of an AE or concomitant medication is incomplete or missing, 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
it will be assumed to have occurred on or after the first dose of study medication, except if an 
incomplete date (e.g., month and year) clearly indicates that the event started prior to treatment.  
If the partial date indicates the same month or year of the first dose of study medication date, 
then the start date of the first dose will be imputed, otherwise, the missing day or month by the 
first day or the first month will be imputed. 
Imputation of Partial AE and concomitant Medication Partial end dates: 
When only year is present, missing AE/concomitant medication end day and month will be 
imputed to the earlier of (study end date, 31DECYYYY).  
When both month and year present, missing AE/concomitant medication end day will imputed to 
the last day of the month. 
There will be no attempt to impute completely missing AE or concomitant medication end dates. 
Events with an end date missing will be assumed to be ongoing at the time of data cut off. 
Missing/Incomplete Medical history dates 
Medical history start dates are used to determine the duration of chronic back pain at baseline per 
eCRF data. Completing missing medical history dates will not imputed. Missing month will be 
imputed to January and missing day will be imputed to the first day of the month.  
Adverse event 
If the intensity of a TEAE is missing, it will be classified as “severe” in the frequency tables by 
intensity of TEAEs. If the assessment of relationship of a TEAE to the investigational product is 
missing, it will be classified as related to the investigational product. 
Other safety data 
For laboratory results below the quantification (LOQ), half of the LOQ will be imputed for 
calculating the descriptive summary. 
No imputations for missing laboratory data, ECG data, vital sign data, or physical examination 
data will be made. 
Date of first / last injection 
Date of first injection is the first non-missing start date of dosing recorded in the CRF 
“Investigational Product” module.
If a patient’s date of the last dose is totally missing or unknown, his/her last visit date in the 
treatment period  will be substituted.  
Missing item data for questionnaires 
LBPI NRS 
Baseline average daily  LBPI  NRS score is defined as the average of the non-missing daily 
LBPI NRS scores for 5 days prior to randomization (from Day -4 to Day 1).  For each week, the 
average daily LBPI score is defined as the average of the non-missing daily LBPI NRS scores for 
the 7days before and including the visit day . 
RMDQ 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
RMDQ total score will be set to missing if any item is missing. 
SF-36 
The Half-Scale rule will be used to impute missing item responses in the SF-36 subscale scores 
i.e. a score will be computed if the respondent answers at least 50% of items in that scale. The 
missing items in the scale will be imputed by the mean of available items rounded to the nearest 
whole number.  
The bodily pain subscale consists of Q7 and Q8 of the instrument. Since Q7 is based on 6pt 
Likert score and Q8 is based on a 5pt Likert scale and because  mean imputation will be 
meaningless,  the bodily pain subscale score will not be imputed if any of the questions making 
up the scale is missing.  
EQ-5D-5L 
Index will be set to missing if any of the 5 dimensions is missing. 
MOS-Sleep 
MOS-Sleep subscale scores will be computed if at least 50% of items are available. The missing 
items will be imputed by the mean of available items. 
6.4.
Data handling for the SF-36 instrument.  
Due to scoring differences amongst the instrument’s 36 items, 10 of the items will need to be 
reverse coded to ensure consistency in reporting such that higher scores are indicative of better 
health.  The SF-36 items needing reverse coding are: Q1, Q6, Q7, Q8, Q9a, Q9d, Q9e, Q9h, 
Q11b, Q11d.  
6.5.
Visit Windows 
By-visit analysis (including efficacy, laboratory data, vital signs, ECG, ADA) will be 
summarized by the nominal visit number and no visit window will be defined.  Assessments 
taken outside of protocol allowable windows will be displayed according to the case report form 
(CRF) assessment recorded by the investigator. For assessments without a nominal visit number 
such as EOT and EOS assessments, a visit number will be assigned based on the actual visit date 
using the study day and visit window as in Appendix 10.2 Table 1 Schedule of Events.  
The following visit windows will be used to map the unscheduled visits, early end of treatment 
visits, early study termination visits and daily electronic dairy entries, based on the study day: 
Visit No.
Visit
Targeted Study Days*
Analysis Window in 
Study Days
1
Screening
Day -37 to day -8
≤8
2
Pre-randomization
Day -7 to -4
-7 to -3
3
Baseline
1
1
4
Week 2
15
[12,18]
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
5
Week 4
29
[22, 36]
6
Week 8
57
[50, 64]
7
Week 12
85
[78, 92]
8
Week 16 (End of Treatment)
113
[106, 120]
9
Week 20
141
[134, 148]
10
Week 36 (End of Study)
253
[246,260]
*Study days are calculated from the first administration of study drug (Day 1) 
If multiple measurements occur within the same analysis window, the following rules will be 
used to determine the analysis value: 
x
When multiple valid measurements occur within the same analysis window, the closest to 
the target study day will be used in the analysis.  
x
When multiple valid measurements occur within equal distance from the target study day, 
the value after the target study day will be used in the analysis.  
Both scheduled and unscheduled measurements will be considered for determining 
abnormal/PCSV values from laboratory, vital sign or ECG as well as the baseline values.  
6.6.
Unscheduled Assessments 
The determination of baselines and values at the end of treatment for both efficacy and safety 
variables will be based on available assessments of scheduled and unscheduled visits. For by 
visit summaries, only scheduled assessments are included.  
6.7.
Pooling of Centers for Statistical Analyses 
There is no pooling of centers planned for the statistical analysis. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
7.
INTERIM ANALYSIS 
An administrative interim analysis may be conducted by a team of independent statisticians and 
programmers. The results of this interim analysis will be used to make appropriate business 
decisions.   
Since the time that dosing was stopped in this study, two unblinded interim analysis of efficacy 
have been conducted. The first unblinded interim analysis was conducted immediately after 
being placed on clinical hold and the second was conducted at the time when the last patient who 
received study drug before the trial was placed on clinical hold would have completed the 
16week time point.  
No new or unexpected safety signals were observed.  
The conduct of these administrative interim analyses was performed by independent personnel 
not involved with the conduct of the study.  Regeneron personnel directly involved in the 
conduct of the study including study medical monitor and biostatistician remain blinded at the 
subject level.   
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
8.
SOFTWARE 
All analyses will be done using SAS Version 9.3 or later version if available. . 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 30 June, 2016 
CONFIDENTIAL 
9.
REFERENCES 
ICH. (1996, July 30). ICH Harmonized tripartite guideline: Structure and  content of clinical 
study reports (E3). International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use. 
ICH. (1997, July 17). ICH Harmonized tripartite guideline: General considerations for clinical 
trials (E8). International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use. 
ICH. (1998, February 5). ICH Harmonized tripartite guideline: Statistical principles for clinical 
trials (E9). International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use. 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
10.
APPENDIX 
10.1.
Schedule of Time and Events 
Table 1 Schedule of Events – Screening and Treatment Periods 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Table 2 Schedule of Events – Follow-up  Period 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Table 3 Schedule of Events – Follow-up for Patients who undergo Total Joint Replacement Surgery 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
10.2.
Criteria for Potentially Clinically Significant Values (PCSV) 
Parameter
Treatment Emergent PCSV
Comments
Clinical Chemistry
ALT*
>3 and ≤ 5 ULN and baseline ≤ 3 
ULN*
>5 and ≤ 10 ULN and baseline ≤ 5 
ULN
>10 and ≤ 20 ULN and baseline ≤ 10 
ULN
>20 ULN and baseline ≤ 20 ULN
Enzyme activity must be expressed in 
ULN, not in IU/L. 
FDA DILI Guidance July 2009.
Each category is calculated 
independently.
* At least one level is required, 
multiple levels are optional for phase 
2/3 studies. If it is desirable to get the 
distribution across the different  
PCSV levels, additional shift table on 
≤3, >3 to ≤5,  > 5 to  ≤10, >10 to ≤20, 
and > 20 category for baseline vs. 
post baseline may be provided 
3DJHRI
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
AST*
>3 and ≤ 5 ULN and baseline ≤ 3 
ULN*
>5 and ≤ 10 ULN and baseline ≤ 5 
ULN
>10 and ≤ 20 ULN and baseline ≤ 10 
ULN
>20 ULN and baseline ≤ 20 ULN
Enzyme activity must be expressed in 
ULN, not in IU/L.
FDA DILI Guidance July 2009.
Each category is calculated 
independently.
* At least one level is required,
multiple levels are optional for phase 
2/3 studies. If it is desirable to get the 
distribution across the different  
PCSV levels, additional shift table on 
≤3, >3 to ≤5,  > 5 to ≤10, >10 to ≤20,
and > 20 category for baseline vs. 
post baseline may be provided
Alkaline 
Phosphatase
>1.5 ULN and baseline ≤ 1.5 ULN
Enzyme activity must be expressed in 
ULN, not in IU/L.
FDA DILI Guidance July 2009.
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
Total Bilirubin* >1.5 and ≤ 2 ULN and baseline ≤ 1.5 
ULN*
>2 ULN and baseline ≤ 2.0 ULN
Must be expressed in ULN, not in 
μmol/L or mg/L. Categories are 
cumulative.
FDA DILI Guidance July 2009.
* At least one level is required, 
multiple levels are optional for phase 
2/3 studies. If it is desirable to get the 
distribution of  significant level, 
additional shift table on  ≤1.5, >1.5 to 
≤2.0 and > 2.0 category for baseline 
vs. post baseline may be provided
ALT/AST and 
Total Bilirubin
(ALT >3 ULN and TBILI>2 ULN) and 
baseline (ALT <=3 ULN or TBILI <=2 
ULN)
(ALT >3 ULN and TBILI>1.5 ULN) 
and baseline (ALT <=3 ULN or TBILI 
<=1.5 ULN)
FDA DILI Guidance July 2009.
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
ALT/AST and 
Total Bilirubin 
and ALP
(ALT >3 ULN and TBILI>2 ULN and 
ALP < 2 ULN) and baseline (ALT <=3 
ULN or TBILI <=2 ULN or ALP >=2 
ULN)
(AST>3 ULN and TBILI>2 ULN and 
ALP < 2 ULN) and baseline (AST <=3 
ULN or TBILI <=2 ULN or ALP >=2 
ULN)
FDA DILI Guidance July 2009.
CPK*
>3 and ≤ 10 ULN and baseline ≤ 
3ULN*
>10 ULN and baseline ≤ 10ULN
FDA Feb 2005.
Am J Cardiol April 2006.
Categories are cumulative.
* At least one level is required, 
multiple levels are optional for phase 
2/3 studies. If it is desirable to get the 
distribution of  significant level, 
additional shift table on ≤3, >3 to 
≤10, and > 10 category for baseline 
vs. post baseline may be provided
Creatinine
≥150 μmol/L (Adults) and baseline < 
150 μmol/L
>=30%  change from baseline and 
<100% change from baseline
≥100% change from baseline
Benichou C., 1994.
3 independent criteria 
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
Uric Acid
Hyperuricemia 
Hypouricemia 
>408 μmol/L and <=408 μmol/L at 
baseline
<120 μmol/L and >= 120 μmol/L at 
baseline
Harrison- Principles of internal 
Medicine 17th Ed., 2008.
Two independent criteria
Blood Urea 
Nitrogen
≥17 mmol/L and <17 mmol/L at 
baseline
Two independent criteria
Chloride
Hypochloremia
Hyperchloremia
<80 mmol/L and baseline ≥ 80 mmol/L 
>115 mmol/L and baseline ≤ 115 
mmol/L 
Two independent criteria 
Sodium
Hyponatremia
Hypernatremia
≤129 mmol/L  and baseline > 129 
mmol/L 
≥160 mmol/L and baseline <160 
mmol/L 
Two independent criteria
Potassium
Hypokalemia
Hyperkalemia
<3 mmol/L and baseline ≥ 3 mmol/L 
≥5.5 mmol/L and baseline <5.5 mmol/L 
FDA Feb 2005.
Two independent criteria
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
Glucose
Hypoglycaemia
Hyperglycaemia
(≤3.9 mmol/L and <LLN) and (>3.9 
mmol/L or >=LLN) at baseline
≥11.1 mmol/L (unfasted); ≥7 mmol/L 
(fasted) and < 11.1 mmol/L (unfasted); 
<7 mmol/L (fasted) at baseline
ADA May 2005.
ADA Jan 2008.
Albumin
≤25 g/L and >25 g/L at baseline
Hematology
WBC
<3.0 Giga/L and >=3.0 Giga/L at 
baseline (Non-Black); 
<2.0 Giga/L and >=2.0 Giga/L at 
baseline (Black)
≥16.0 Giga/L and < 16 Giga/L at 
baseline
Increase in WBC: not relevant.
To be interpreted only if no 
differential count available.
Lymphocytes
>4.0 Giga/L and <= 4.0 Giga/L at 
baseline
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
Neutrophils
<1.5 Giga/L and >=1.5 Giga/L at 
baseline (Non-Black); 
<1.0 Giga/L and >=1.0 Giga/L at 
baseline (Black)
International Consensus meeting on
drug-induced blood cytopenias, 1991.
FDA criteria.
Monocytes
>0.7 Giga/L <= 0.7 Giga/L at baseline
Basophils
>0.1 Giga/L <= 0.1 Giga/L at baseline
Eosinophils
(>0.5 Giga/L and >ULN) and (<=0.5 
Giga/L or <= ULN at baseline)
Harrison- Principles of internal 
Medicine 17th Ed., 2008.
Hemoglobin
≤115 g/L and > 115 g/L at baseline for 
male;
≤95 g/L and> 95 g/L at baseline for 
Female.
≥185 g/L and <185 g/L at baseline for 
Male;
≥165 g/L and < 165 g/L at baseline for 
Female
Decrease from Baseline ≥20 g/L
Three criteria are independent.
Criteria based upon decrease from 
baseline are more relevant than based 
on absolute value. Other categories 
for decrease from baseline can be 
used (≥30 g/L, ≥40 g/L, ≥50 g/L).
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
Hematocrit
≤0.37 v/v and > 0.37 v/v at baseline for 
Male ; ≤0.32 v/v and > 0.32 v/v at 
baseline forFemale
≥0.55 v/v and < 0.55 v/v at baseline for 
Male ; ≥0.5 v/v and < 0.5 v/v at 
baseline for Female
Two Criteria are independent
RBC
Female
<3 Tera/L and baseline ≥3 Tera/L
≥6 Tera/L and baseline < 6 Tera/L 
Male
<4 Tera/L and baseline ≥4 Tera/L
≥7 Tera/L and baseline < 7 Tera/L
Unless specifically required for 
particular drug development, the 
analysis is redundant with that of Hb.
Otherwise, consider FDA criteria.
Platelets
<100 Giga/L and >=100 Giga/L at 
baseline
≥700 Giga/L and < 700 Giga/L at 
baseline
International Consensus meeting on 
drug-induced blood cytopenias, 1991.
Two independent criteria
Urinalysis
pH
≤4.6 and > 4.6 at baseline
≥8 and < 8 at baseline
Two independent criteria
Vital signs
3DJHRI
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
HR
≤50 bpm and decrease from baseline 
≥20 bpm
≥120 bpm and increase from 
baseline≥20 bpm
To be applied for all positions 
(including missing) except 
STANDING.
SBP
≤95 mmHg and decrease from baseline 
≥20mmHg
≥160 mmHg and increase from baseline 
≥20 mmHg
To be applied for all positions 
(including missing) except 
STANDING.
DBP
≤45 mmHg and decrease from baseline 
≥10 mmHg
≥110 mmHg and increase from baseline 
≥10 mmHg
To be applied for all positions 
(including missing) except 
STANDING.
Orthostatic 
Hypotension
Su SBP < 160 mmHg -
SBP St – Su d - 20 mmHg
DBP St – Su d - 10 mmHg
Su SBP t 160 mmHg –
SBP St – Su d - 30 mmHg
DBP St – Su d - 15 mmHg
Weight
≥5% increase from baseline 
≥5% decrease from baseline
FDA Feb 2007.
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
Parameter
Treatment Emergent PCSV
Comments
ECG
Ref.: CPMP 1997 guideline. ICH E14 
2005
HR
≤50 bpm and decrease from baseline 
≥20 bpm
≥120 bpm and increase from baseline 
≥20 bpm
PR
≥220 ms and increase from baseline 
≥20 ms
QRS
≥120 ms & < 120 ms at baseline
QTc
Absolute values (ms)
>450 ms and baseline <=450 ms
>480 ms  and baseline <=480 ms
>500 ms and <= 500 ms at baseline
Increase from baseline
Increase from baseline 30-60 ms
Increase from baseline >60 ms
To be applied to any kind of QT 
correction formula. 
'QTc>60 ms are the PCSA to be 
identified in individual 
subjects/patients listings.
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Regeneron Pharmaceuticals, Inc. 
Protocol: R475-PN-1524
Statistical Analysis Plan 
Date: 04 March, 2016 
CONFIDENTIAL 
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