RN624 For Pain Of Post-Herpetic Neuralgia

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00568321

Collaborator

(none)

Enrollment

Locations

Arms

12.6

Actual Duration (Months)

3.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).

Condition or Disease	Intervention/Treatment	Phase
Neuralgia, Postherpetic	Drug: RN624 Drug: RN624 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH POST-HERPETIC NEURALGIA

Actual Study Start Date :

Dec 19, 2007

Actual Primary Completion Date :

Dec 20, 2008

Actual Study Completion Date :

Jan 7, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: RN624 50 mcg/kg
Active Comparator: 2	Drug: RN624 200 mcg/kg
Placebo Comparator: 3	Drug: Placebo placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: RN624

50 mcg/kg

Active Comparator: 2

Drug: RN624

200 mcg/kg

Placebo Comparator: 3

Drug: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 [Baseline, Week 6]
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.

Secondary Outcome Measures

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 [Baseline, Week 1, 2, 4, 8, 12, 16]
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 [Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16]
Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value.
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 [Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16]
mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score.
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 [Week 1, 2, 4, 6, 8, 12, 16]
Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported.
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 [Baseline, Week 6]
Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.
Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6 [Baseline, Week 6]
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 [Baseline, Week 1, 2, 4, 6, 8, 12, 16]
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.
Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score [Baseline up to Week 16]
Time to achieve >=30% or >=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain.
Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants [Baseline to Week 16]
Total duration of response was defined as total number of days with a reduction of >=30% or >=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of >=30% or >=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported.
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 [Baseline, Week 1, 2, 4, 6, 8, 12 and 16]
mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported.
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 [Baseline, Week 1, 2, 4, 6, 8 ,12, 16]
Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented.
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication [Week 1, 2, 4, 6, 8, 12, 16]
Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported.
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 [Baseline, Week 1, 2, 4, 6, 8, 12, 16]
mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported.
Number of Participants Who Discontinued the Study Due to Lack of Efficacy [Baseline up to Week 16]
Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 16]
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
Number of Participants Who Used Rescue Medications [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16]
In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized.
Duration of Rescue Medication Use [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16]
In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized.
Amount of Rescue Medication Taken [Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16]
In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 112 days after the last dose of study drug (up to Week 16)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Abnormal Physical Examinations Findings at Screening [Screening visit (1 day prior to Day 1 baseline visit)]
Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion.
Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16 [Baseline, Week 16]
Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.
Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16 [Baseline, Week 16]
Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation).
Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16 [Baseline, Week 16]
Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (<) 40 beats per minute and greater than (>) 150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute.
Number of Participants With Laboratory Abnormalities [Baseline up to Week 16]
Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium <0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).
Number of Participants With Electrocardiogram (ECG) Abnormalities [Baseline up to Week 16]
Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Number of Participants With Positive Anti-Drug Antibody (ADA) Response [Baseline up to Week 16]
Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for PF-04383119 were considered as ADA positive.
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study [Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)]
HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab [Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1]
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Other Outcome Measures

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab [Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1]
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose [1, 2688 hours postdose on Day 1]
Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported.
Total Clearance of Tanezumab From Plasma [Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Terminal Elimination Half-Life (t1/2) of Tanezumab [Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1]
Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration.
Volume of Distribution at Steady State (Vss) for Tanezumab [Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female of any race, at least 18 years of age.
Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
Has a pain score at screening that qualifies.
Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
Body Mass Index less than or equal to 39 kg/m2.
If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Patients must consent in writing to participate in the study.

Exclusion Criteria:

Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
Disqualifying scores on questionnaires.
Other moderate to severe pain from other conditions.
History of allergic or anaphylactic reaction to antibodies.
Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
Unable to use acetaminophen.
Disqualify laboratory values, Hepatitis B or C or HIV.
Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
Cancer other than basal cell or squamous cell carcinoma.
Fails a urine test for illegal drugs including prescription drugs without a prescription.
Plans for surgery during the study.
History of alcoholism or drug abuse in the past two years.
Surgery for post-herpetic neuralgia.
Any condition that the investigator feels would put the safety of the patient at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anniston Medical Clinic/Pinnacle Research Group LLC	Anniston	Alabama	United States	36207
2	Anniston Neurology & Headache Mgmt. Ctr.	Anniston	Alabama	United States	36207
3	Dedicated Clinical Research, Inc.	Litchfield Park	Arizona	United States	85340
4	Arizona Research Center	Phoenix	Arizona	United States	85023
5	Jem Research, LLC	Atlantis	Florida	United States	33462
6	Clinical Research of West Florida	Clearwater	Florida	United States	33765
7	Innovative Research of West Florida, Inc.	Largo	Florida	United States	33770
8	Miami Medical Associates	Miami	Florida	United States	33175
9	Palm Beach Neurological Center, Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida	United States	33418
10	Neurology Clinical Research, Inc.	Sunrise	Florida	United States	33351
11	Meridien Research	Tampa	Florida	United States	33606
12	Cotton-O'Neil Clinical Research	Topeka	Kansas	United States	66606
13	Cotton-O'Neil Clinic	Topeka	Kansas	United States	66606
14	International Research Center	Towson	Maryland	United States	21286
15	Infinity Medical Research, Inc.	North Dartmouth	Massachusetts	United States	02747
16	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan	United States	48104
17	Medical Advanced Pain Specialists (MAPS)	Edina	Minnesota	United States	55435
18	A & A Pain Institute	Saint Louis	Missouri	United States	63141
19	Asheville Neurology Specialists, PA	Asheville	North Carolina	United States	28806
20	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
21	Hometown Urgent Care and Research	Dayton	Ohio	United States	45432
22	Wells Institute for Health Awareness	Kettering	Ohio	United States	45429
23	Allegheny Pain Management, PC	Altoona	Pennsylvania	United States	16602
24	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635-0909
25	DiscoveResearch Incorporated	Bryan	Texas	United States	77802
26	Neurological Clinic of Texas	Dallas	Texas	United States	75230
27	Mobley Research Center	Houston	Texas	United States	77024
28	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
29	Jay Ellis Jr., MD-Tejas Anesthesia	San Antonio	Texas	United States	78229
30	Radiant Research San Antonio Northeast	San Antonio	Texas	United States	78229
31	National Clinical Research, Incorporated	Richmond	Virginia	United States	23294

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00568321

Other Study ID Numbers:

A4091005
PHN POC

First Posted:

Dec 6, 2007

Last Update Posted:

May 28, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Pfizer

monoclonal antibody

Additional relevant MeSH terms:

Neuralgia

Neuralgia, Postherpetic

Tanezumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Period Title: Overall Study
STARTED	33	33	33
Treated	31	33	32
COMPLETED	20	28	24
NOT COMPLETED	13	5	9

Baseline Characteristics

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg	Total
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).	Total of all reporting groups
Overall Participants	31	33	32	96
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.9 (8.7)	71.9 (8.5)	65.9 (14.6)	69.6 (11.2)
Sex: Female, Male (Count of Participants)
Female	13 41.9%	16 48.5%	15 46.9%	44 45.8%
Male	18 58.1%	17 51.5%	17 53.1%	52 54.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
Description	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed (n)" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Baseline	6.40 (1.55)	6.42 (1.57)	6.39 (1.58)
Change at Week 6	-1.22 (1.72)	-0.97 (1.20)	-1.72 (2.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.687
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 90% -0.50 to 0.92
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.43
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.111
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean difference
	Estimated Value	-0.53
	Confidence Interval	(2-Sided) 90% -1.25 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Description	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.
Time Frame	Baseline, Week 1, 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Change at Week 1	-0.54 (1.25)	-0.64 (1.19)	-0.91 (1.36)
Change at Week 2	-0.80 (1.65)	-0.46 (1.42)	-0.66 (1.73)
Change at Week 4	-1.30 (1.61)	-0.97 (1.15)	-1.46 (1.91)
Change at Week 8	-1.18 (1.47)	-1.10 (1.36)	-1.72 (2.34)
Change at Week 12	-1.13 (1.46)	-1.49 (1.66)	-1.45 (2.44)
Change at Week 16	-1.18 (1.61)	-1.70 (1.78)	-1.76 (2.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.399
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90% -0.79 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.41
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.189
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 90% -1.06 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.802
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 90% -0.33 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.582
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90% -0.61 to 0.78
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.789
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 90% -0.36 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.290
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90% -0.94 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.42
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.568
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 90% -0.65 to 0.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.44
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.116
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 90% -1.27 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.218
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 90% -1.11 to 0.40
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.261
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 90% -1.06 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.252
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 90% -1.11 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.48
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.182
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 90% -1.26 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16
Description	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value.
Time Frame	Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Weeks 1 to 4	-0.87 (1.43)	-0.70 (1.13)	-1.08 (1.53)
Weeks 1 to 8	-0.97 (1.37)	-0.81 (1.03)	-1.35 (1.74)
Weeks 1 to 12	-1.01 (1.25)	-0.97 (1.07)	-1.38 (1.75)
Weeks 1 to 16	-1.02 (1.17)	-1.03 (1.16)	-1.43 (1.81)
Weeks 5 to 8	-1.18 (1.50)	-1.01 (1.15)	-1.61 (2.21)
Weeks 5 to 12	-1.19 (1.34)	-1.20 (1.27)	-1.50 (2.08)
Weeks 5 to 16	-1.19 (1.27)	-1.25 (1.38)	-1.52 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.683
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90% -0.46 to 0.84
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.310
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 90% -0.85 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.40
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.668
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90% -0.46 to 0.78
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.165
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 90% -0.99 to 0.26
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.38
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.546
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90% -0.55 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.36
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.190
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 90% -0.92 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.36
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.467
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90% -0.60 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.35
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.153
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 90% -0.94 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.35
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.632
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90% -0.54 to 0.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.41
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.094
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 90% -1.22 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.41
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.468
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90% -0.68 to 0.61
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.167
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 90% -1.03 to 0.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.39
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.394
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 90% -0.72 to 0.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.138
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 90% -1.04 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.38
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16
Description	mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score.
Time Frame	Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	30	32	30
Baseline: Worst Pain	7.13 (1.57)	6.78 (1.79)	6.93 (1.48)
Baseline: Average Pain	6.27 (1.46)	6.06 (1.72)	6.20 (1.58)
Baseline: Pain Severity	24.77 (6.43)	23.78 (7.23)	23.87 (5.90)
Change at Week 1: Worst Pain	-1.10 (2.08)	-0.57 (2.22)	-0.71 (1.58)
Change at Week 1: Average Pain	-0.83 (1.54)	-0.46 (1.43)	-0.79 (1.55)
Change at Week 1: Pain Severity	-3.59 (7.06)	-1.82 (6.42)	-2.79 (6.64)
Change at Week 2: Worst Pain	-1.38 (2.14)	-0.52 (1.92)	-0.96 (2.51)
Change at Week 2: Average Pain	-1.19 (1.72)	-0.41 (1.18)	-0.85 (2.24)
Change at Week 2: Pain Severity	-5.31 (7.17)	-1.86 (5.88)	-3.58 (9.38)
Change at Week 4: Worst Pain	-1.44 (2.26)	-0.93 (1.15)	-1.18 (2.21)
Change at Week 4: Average Pain	-1.44 (1.64)	-0.75 (1.04)	-1.39 (2.11)
Change at Week 4: Pain Severity	-5.68 (7.40)	-3.82 (4.26)	-5.21 (8.80)
Change at Week 6: Worst Pain	-1.24 (1.76)	-0.93 (1.57)	-1.76 (2.74)
Change at Week 6: Average Pain	-1.19 (1.63)	-0.78 (1.34)	-1.72 (2.39)
Change at Week 6: Pain Severity	-4.57 (5.81)	-4.07 (4.95)	-7.00 (10.39)
Change at Week 8: Worst Pain	-2.00 (1.56)	-1.26 (2.09)	-1.81 (3.16)
Change at Week 8: Average Pain	-1.60 (1.54)	-0.96 (1.43)	-1.77 (2.44)
Change at Week 8: Pain Severity	-7.60 (5.22)	-5.04 (5.78)	-6.65 (10.55)
Change at Week 12: Worst Pain	-1.67 (1.49)	-1.50 (2.09)	-1.64 (3.28)
Change at Week 12: Average Pain	-1.38 (1.50)	-1.17 (1.49)	-1.56 (2.45)
Change at Week 12: Pain Severity	-5.76 (6.03)	-5.83 (7.24)	-5.60 (10.38)
Change at Week 16: Worst Pain	-1.90 (1.37)	-1.63 (2.26)	-2.38 (3.06)
Change at Week 16: Average Pain	-1.50 (1.28)	-1.25 (1.78)	-1.95 (2.62)
Change at Week 16: Pain Severity	-6.40 (4.91)	-6.17 (7.95)	-8.38 (10.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.764
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 90% -0.51 to 1.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.750
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 90% -0.54 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.734
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 90% -0.46 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.514
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90% -0.73 to 0.77
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.765
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.37
	Confidence Interval	(2-Sided) 90% -1.76 to 4.50
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.89
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.646
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 90% -2.43 to 3.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.90
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.895
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 90% -0.22 to 1.60
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.776
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 90% -0.50 to 1.34
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.944
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 90% -0.03 to 1.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.45
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.835
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 90% -0.31 to 1.21
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.955
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.23
	Confidence Interval	(2-Sided) 90% 0.09 to 6.37
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.90
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.884
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.31
	Confidence Interval	(2-Sided) 90% -0.88 to 5.49
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.93
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.737
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 90% -0.57 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 90% -0.74 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.925
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 90% -0.10 to 1.43
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.518
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90% -0.75 to 0.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.46
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.810
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.70
	Confidence Interval	(2-Sided) 90% -1.49 to 4.88
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.93
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.600
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 90% -2.72 to 3.70
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.94
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.651
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 90% -0.73 to 1.18
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.58
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.342
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90% -1.21 to 0.73
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.59
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.768
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 90% -0.44 to 1.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.48
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.211
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 90% -1.19 to 0.41
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.48
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.610
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 90% -2.73 to 3.85
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.99
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.241
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.43
	Confidence Interval	(2-Sided) 90% -4.76 to 1.91
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.02
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.789
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 90% -0.50 to 1.45
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.59
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.570
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90% -0.88 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.60
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.782
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 90% -0.43 to 1.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.295
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 90% -1.08 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.49
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.804
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.75
	Confidence Interval	(2-Sided) 90% -1.62 to 5.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.04
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.655
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 90% -2.58 to 4.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.06
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.409
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 90% -1.13 to 0.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.60
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.482
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90% -1.03 to 0.97
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.61
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.592
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 90% -0.71 to 0.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.368
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90% -1.00 to 0.66
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.396
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 90% -3.98 to 2.88
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.08
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.545
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 90% -3.21 to 3.69
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.09
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.486
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90% -1.04 to 1.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.62
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.324
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 90% -1.33 to 0.75
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.563
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 90% -0.76 to 0.92
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.282
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 90% -1.16 to 0.56
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.409
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 90% -3.99 to 3.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.12
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.293
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.18
	Confidence Interval	(2-Sided) 90% -4.76 to 2.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.17
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16
Description	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported.
Time Frame	Week 1, 2, 4, 6, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1	0 0%	2 6.1%	1 3.1%
Week 2	1 3.2%	2 6.1%	1 3.1%
Week 4	1 3.2%	0 0%	2 6.3%
Week 6	2 6.5%	2 6.1%	7 21.9%
Week 8	2 6.5%	1 3%	6 18.8%
Week 12	3 9.7%	4 12.1%	4 12.5%
Week 16	2 6.5%	4 12.1%	4 12.5%

6. Secondary Outcome

Title	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6
Description	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Greater than 0% reduction	19 61.3%	22 66.7%	19 59.4%
Greater than or equal to (>=)10% reduction	15 48.4%	15 45.5%	17 53.1%
>=20% reduction	13 41.9%	11 33.3%	14 43.8%
>=30% reduction	7 22.6%	7 21.2%	12 37.5%
>=40% reduction	5 16.1%	4 12.1%	11 34.4%
>=50% reduction	4 12.9%	3 9.1%	8 25%
>=60% reduction	3 9.7%	2 6.1%	6 18.8%
>=70% reduction	1 3.2%	0 0%	5 15.6%
>=80% reduction	1 3.2%	0 0%	2 6.3%
>=90% reduction	0 0%	0 0%	1 3.1%
100% reduction	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6
Description	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
>=30% reduction	14 45.2%	14 42.4%	16 50%
>=50% reduction	11 35.5%	9 27.3%	13 40.6%

8. Secondary Outcome

Title	Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16
Description	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.
Time Frame	Baseline, Week 1, 2, 4, 6, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at specified categories.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1: >=30% reduction	4 12.9%	5 15.2%	5 15.6%
Week 2: >=30% reduction	6 19.4%	4 12.1%	6 18.8%
Week 4: >=30% reduction	10 32.3%	8 24.2%	12 37.5%
Week 6: >=30% reduction	7 22.6%	7 21.2%	12 37.5%
Week 8: >=30% reduction	5 16.1%	9 27.3%	13 40.6%
Week 12: >=30% reduction	7 22.6%	10 30.3%	10 31.3%
Week 16: >=30% reduction	6 19.4%	10 30.3%	9 28.1%
Week 1: >=50% reduction	1 3.2%	3 9.1%	2 6.3%
Week 2: >=50% reduction	2 6.5%	3 9.1%	2 6.3%
Week 4: >=50% reduction	4 12.9%	2 6.1%	6 18.8%
Week 6: >=50% reduction	4 12.9%	3 9.1%	8 25%
Week 8: >=50% reduction	2 6.5%	2 6.1%	9 28.1%
Week 12: >=50% reduction	6 19.4%	6 18.2%	7 21.9%
Week 16: >=50% reduction	4 12.9%	6 18.2%	6 18.8%

9. Secondary Outcome

Title	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score
Description	Time to achieve >=30% or >=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies number of participants who had sustained response.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Time to >=30% Reduction	65.00	NA	57.00
Time to >=50% Reduction	NA	NA	NA

10. Secondary Outcome

Title	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants
Description	Total duration of response was defined as total number of days with a reduction of >=30% or >=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of >=30% or >=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Total duration for >=30% reduction	8.00 (34.45)	2.00 (35.44)	14.50 (38.55)
Total duration for >=50% reduction	0.00 (25.93)	0.00 (26.91)	2.50 (33.15)

11. Secondary Outcome

Title	Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16
Description	mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported.
Time Frame	Baseline, Week 1, 2, 4, 6, 8, 12 and 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	30	32	30
Baseline: CS	3.87 (2.29)	3.90 (2.46)	4.67 (2.05)
Baseline: GA	4.13 (2.75)	4.16 (3.09)	4.83 (2.28)
Baseline: NW	3.53 (2.66)	3.75 (2.93)	5.00 (2.56)
Change at Week 1: CS	-0.86 (2.56)	-0.90 (1.24)	-0.99 (2.28)
Change at Week 1: GA	-0.76 (3.12)	-0.57 (2.04)	-1.14 (2.86)
Change at Week 1: NW	-0.48 (2.86)	-1.07 (1.36)	-1.48 (2.56)
Change at Week 2: CS	-1.47 (2.18)	-0.69 (1.65)	-1.23 (2.67)
Change at Week 2: GA	-1.58 (2.84)	-0.55 (2.29)	-1.04 (3.49)
Change at Week 2: NW	-1.19 (2.76)	-0.59 (2.13)	-1.40 (2.68)
Change at Week 4: CS	-1.22 (1.98)	-1.26 (1.66)	-1.54 (2.46)
Change at Week 4: GA	-1.28 (2.61)	-1.18 (2.45)	-1.57 (3.35)
Change at Week 4: NW	-1.04 (2.09)	-1.29 (1.98)	-1.63 (2.71)
Change at Week 6: CS	-1.01 (1.60)	-1.20 (1.57)	-1.65 (2.77)
Change at Week 6: GA	-1.05 (2.18)	-1.04 (2.14)	-1.36 (3.68)
Change at Week 6: NW	-0.62 (2.18)	-1.15 (2.03)	-1.63 (3.15)
Change at Week 8: CS	-1.37 (1.75)	-1.11 (1.83)	-1.41 (2.60)
Change at Week 8: GA	-1.55 (2.28)	-1.04 (2.17)	-1.23 (3.39)
Change at Week 8: NW	-1.10 (2.13)	-0.96 (2.23)	-1.52 (2.76)
Change at Week 12: CS	-0.89 (1.69)	-1.07 (2.04)	-1.25 (3.25)
Change at Week 12: GA	-0.86 (2.54)	-0.92 (2.36)	-0.92 (4.08)
Change at Week 12: NW	-0.52 (2.34)	-1.00 (2.21)	-1.25 (3.33)
Change at Week 16: CS	-1.46 (1.21)	-1.23 (2.02)	-1.82 (3.00)
Change at Week 16: GA	-1.40 (1.82)	-1.21 (2.21)	-2.10 (3.77)
Change at Week 16: NW	-1.30 (1.78)	-1.21 (2.26)	-1.80 (3.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.343
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 90% -1.03 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.576
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90% -0.75 to 0.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.460
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 90% -1.10 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.435
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 90% -1.15 to 0.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.104
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 90% -1.62 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.204
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 90% -1.42 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.57
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.931
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 90% -0.08 to 1.58
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.941
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 90% -0.04 to 1.67
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.936
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 90% -0.08 to 2.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.965
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 90% 0.11 to 2.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.64
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.855
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 90% -0.33 to 1.51
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.765
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 90% -0.54 to 1.38
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.58
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.504
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90% -0.84 to 0.85
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.51
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.643
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90% -0.67 to 1.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.52
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.486
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90% -1.09 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.64
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.600
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90% -0.91 to 1.24
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.65
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.418
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 90% -1.05 to 0.82
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.57
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.515
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90% -0.95 to 0.99
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.59
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.456
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 90% -0.93 to 0.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.53
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.556
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 90% -0.82 to 0.97
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.54
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.448
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 90% -1.19 to 1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.67
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.600
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 90% -0.95 to 1.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.68
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.225
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 90% -1.41 to 0.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.59
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.387
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90% -1.18 to 0.83
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.61
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.657
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 90% -0.67 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.54
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.808
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 90% -0.43 to 1.40
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.742
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 90% -0.68 to 1.57
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.68
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.923
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 90% -0.16 to 2.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.70
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.490
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90% -1.01 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.60
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.609
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 90% -0.86 to 1.20
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.62
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.362
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 90% -1.10 to 0.71
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.610
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90% -0.77 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.376
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 90% -1.37 to 0.93
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.70
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.733
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 90% -0.73 to 1.60
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.71
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.303
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 90% -1.33 to 0.69
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.61
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.548
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 90% -0.97 to 1.12
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.609
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90% -0.77 to 1.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.590
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 90% -0.83 to 1.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.59
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.556
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90% -1.07 to 1.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.71
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.443
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90% -1.32 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.73
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.527
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90% -0.99 to 1.07
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.62
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.583
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90% -0.95 to 1.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.66
	Estimation Comments

12. Secondary Outcome

Title	Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16
Description	Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented.
Time Frame	Baseline, Week 1, 2, 4, 6, 8 ,12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1: Change= --4	0 0%	0 0%	0 0%
Week 1: Change= --3	1 3.2%	0 0%	0 0%
Week 1: Change= --2	3 9.7%	1 3%	0 0%
Week 1: Change= --1	4 12.9%	4 12.1%	8 25%
Week 1: Change= 0	15 48.4%	19 57.6%	11 34.4%
Week 1: Change= 1	5 16.1%	4 12.1%	7 21.9%
Week 1: Change= 2	1 3.2%	1 3%	0 0%
Week 1: Change= 3	0 0%	0 0%	0 0%
Week 1: Change= 4	0 0%	0 0%	1 3.1%
Week 2: Change= --4	0 0%	0 0%	0 0%
Week 2: Change= --3	1 3.2%	0 0%	0 0%
Week 2: Change= --2	3 9.7%	0 0%	2 6.3%
Week 2: Change= --1	5 16.1%	7 21.2%	2 6.3%
Week 2: Change= 0	15 48.4%	15 45.5%	17 53.1%
Week 2: Change= 1	2 6.5%	7 21.2%	3 9.4%
Week 2: Change= 2	0 0%	0 0%	1 3.1%
Week 2: Change= 3	1 3.2%	0 0%	0 0%
Week 2: Change= 4	0 0%	0 0%	0 0%
Week 4: Change= --4	0 0%	0 0%	0 0%
Week 4: Change= --3	1 3.2%	0 0%	0 0%
Week 4: Change= --2	1 3.2%	1 3%	1 3.1%
Week 4: Change= --1	7 22.6%	5 15.2%	8 25%
Week 4: Change= 0	10 32.3%	20 60.6%	16 50%
Week 4: Change= 1	5 16.1%	1 3%	2 6.3%
Week 4: Change= 2	0 0%	1 3%	0 0%
Week 4: Change= 3	1 3.2%	0 0%	0 0%
Week 4: Change= 4	0 0%	0 0%	0 0%
Week 6: Change= --4	0 0%	0 0%	0 0%
Week 6: Change= --3	0 0%	0 0%	0 0%
Week 6: Change= --2	1 3.2%	1 3%	2 6.3%
Week 6: Change= --1	6 19.4%	7 21.2%	6 18.8%
Week 6: Change= 0	11 35.5%	17 51.5%	13 40.6%
Week 6: Change= 1	3 9.7%	0 0%	2 6.3%
Week 6: Change= 2	0 0%	2 6.1%	1 3.1%
Week 6: Change= 3	0 0%	0 0%	0 0%
Week 6: Change= 4	0 0%	0 0%	0 0%
Week 8: Change= --4	0 0%	0 0%	0 0%
Week 8: Change= --3	0 0%	0 0%	0 0%
Week 8: Change= --2	1 3.2%	1 3%	2 6.3%
Week 8: Change= -1	7 22.6%	7 21.2%	8 25%
Week 8: Change= 0	9 29%	17 51.5%	12 37.5%
Week 8: Change= 1	3 9.7%	1 3%	2 6.3%
Week 8: Change= 2	0 0%	1 3%	1 3.1%
Week 8: Change= 3	0 0%	0 0%	0 0%
Week 8: Change= 4	0 0%	0 0%	0 0%
Week 12: Change= -4	0 0%	0 0%	0 0%
Week 12: Change= -3	0 0%	0 0%	1 3.1%
Week 12: Change= -2	0 0%	1 3%	3 9.4%
Week 12: Change= -1	6 19.4%	6 18.2%	5 15.6%
Week 12: Change= 0	11 35.5%	12 36.4%	12 37.5%
Week 12: Change= 1	3 9.7%	4 12.1%	3 9.4%
Week 12: Change= 2	1 3.2%	1 3%	0 0%
Week 12: Change= 3	0 0%	0 0%	0 0%
Week 12: Change= 4	0 0%	0 0%	0 0%
Week 16: Change= -4	0 0%	0 0%	0 0%
Week 16: Change= -3	0 0%	0 0%	1 3.1%
Week 16: Change= -2	0 0%	1 3%	1 3.1%
Week 16: Change= -1	5 16.1%	5 15.2%	6 18.8%
Week 16: Change= 0	14 45.2%	15 45.5%	10 31.3%
Week 16: Change= 1	1 3.2%	2 6.1%	2 6.3%
Week 16: Change= 2	0 0%	1 3%	0 0%
Week 16: Change= 3	0 0%	0 0%	0 0%
Week 16: Change= 4	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication
Description	Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported.
Time Frame	Week 1, 2, 4, 6, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1: Poor	11 35.5%	13 39.4%	13 40.6%
Week 1: Fair	5 16.1%	5 15.2%	8 25%
Week 1: Good	11 35.5%	9 27.3%	7 21.9%
Week 1: Excellent	2 6.5%	3 9.1%	1 3.1%
Week 2: Poor	7 22.6%	12 36.4%	13 40.6%
Week 2: Fair	6 19.4%	4 12.1%	9 28.1%
Week 2: Good	11 35.5%	11 33.3%	4 12.5%
Week 2: Excellent	3 9.7%	2 6.1%	1 3.1%
Week 4: Poor	7 22.6%	7 21.2%	7 21.9%
Week 4: Fair	9 29%	11 33.3%	14 43.8%
Week 4: Good	8 25.8%	10 30.3%	6 18.8%
Week 4: Excellent	2 6.5%	1 3%	2 6.3%
Week 6: Poor	7 22.6%	8 24.2%	7 21.9%
Week 6: Fair	8 25.8%	9 27.3%	7 21.9%
Week 6: Good	5 16.1%	11 33.3%	7 21.9%
Week 6: Excellent	2 6.5%	0 0%	5 15.6%
Week 8: Poor	4 12.9%	9 27.3%	10 31.3%
Week 8: Fair	4 12.9%	9 27.3%	5 15.6%
Week 8: Good	10 32.3%	8 24.2%	7 21.9%
Week 8: Excellent	2 6.5%	2 6.1%	4 12.5%
Week 12: Poor	7 22.6%	8 24.2%	10 31.3%
Week 12: Fair	6 19.4%	8 24.2%	5 15.6%
Week 12: Good	9 29%	7 21.2%	5 15.6%
Week 12: Excellent	0 0%	2 6.1%	4 12.5%
Week 16: Poor	3 9.7%	6 18.2%	6 18.8%
Week 16: Fair	7 22.6%	8 24.2%	6 18.8%
Week 16: Good	8 25.8%	7 21.2%	5 15.6%
Week 16: Excellent	3 9.7%	4 12.1%	4 12.5%

14. Secondary Outcome

Title	Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16
Description	mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported.
Time Frame	Baseline, Week 1, 2, 4, 6, 8, 12, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, ''overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	30	32	29
Baseline	4.87 (3.06)	4.66 (2.74)	5.48 (2.59)
Change at Week 1	-1.03 (3.34)	-1.50 (2.20)	-1.37 (3.21)
Change at Week 2	-1.96 (2.68)	-1.03 (2.78)	-1.72 (3.81)
Change at Week 4	-1.60 (2.66)	-1.71 (2.19)	-2.04 (3.13)
Change at Week 6	-1.19 (1.72)	-1.85 (2.23)	-2.46 (3.40)
Change at Week 8	-1.80 (1.88)	-1.81 (2.69)	-2.16 (3.41)
Change at Week 12	-1.38 (1.96)	-1.63 (2.83)	-1.83 (4.25)
Change at Week 16	-1.90 (1.52)	-1.71 (3.22)	-2.45 (3.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.111
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 90% -1.81 to 0.27
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.523
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90% -1.02 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.64
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.887
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 90% -0.28 to 1.81
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.63
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.903
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 90% -0.23 to 1.92
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.65
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.472
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90% -1.11 to 1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.64
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 90% -0.87 to 1.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.66
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.243
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 90% -1.58 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.67
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.346
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 90% -1.42 to 0.87
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.69
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.467
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 90% -1.19 to 1.08
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.69
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.670
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 90% -0.85 to 1.47
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.70
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.286
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 90% -1.55 to 0.76
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.70
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.598
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 90% -1.00 to 1.35
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.71
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.453
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 90% -1.26 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.71
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.472
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90% -1.28 to 1.17
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.74
	Estimation Comments

15. Secondary Outcome

Title	Number of Participants Who Discontinued the Study Due to Lack of Efficacy
Description
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Count of Participants [Participants]	8 25.8%	5 15.2%	6 18.8%

16. Secondary Outcome

Title	Time to Discontinuation Due to Lack of Efficacy
Description	Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Mean (Standard Error) [days]	71.32 (4.95)	40.79 (1.82)	72.13 (3.91)

17. Secondary Outcome

Title	Number of Participants Who Used Rescue Medications
Description	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized.
Time Frame	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1	18 58.1%	22 66.7%	12 37.5%
Week 2	16 51.6%	17 51.5%	14 43.8%
Week 3	15 48.4%	17 51.5%	17 53.1%
Week 4	10 32.3%	18 54.5%	13 40.6%
Week 5	11 35.5%	16 48.5%	10 31.3%
Week 6	12 38.7%	15 45.5%	15 46.9%
Week 7	10 32.3%	13 39.4%	13 40.6%
Week 8	7 22.6%	17 51.5%	11 34.4%
Week 9	6 19.4%	15 45.5%	12 37.5%
Week 10	9 29%	14 42.4%	13 40.6%
Week 11	9 29%	15 45.5%	11 34.4%
Week 12	10 32.3%	17 51.5%	11 34.4%
Week 13	8 25.8%	15 45.5%	9 28.1%
Week 14	10 32.3%	15 45.5%	8 25%
Week 15	8 25.8%	12 36.4%	12 37.5%
Week 16	6 19.4%	14 42.4%	13 40.6%

18. Secondary Outcome

Title	Duration of Rescue Medication Use
Description	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized.
Time Frame	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1	1.00	1.00	0.00
Week 2	1.00	1.00	0.00
Week 3	0.00	1.00	1.50
Week 4	0.00	1.00	0.00
Week 5	0.00	1.00	0.00
Week 6	0.00	1.00	1.00
Week 7	0.00	0.00	0.00
Week 8	0.00	1.00	0.00
Week 9	0.00	1.00	0.00
Week 10	0.00	0.50	0.00
Week 11	0.00	1.00	0.00
Week 12	0.00	1.00	0.00
Week 13	0.00	1.00	0.00
Week 14	0.00	1.00	0.00
Week 15	0.00	0.00	0.50
Week 16	0.00	1.00	1.00

19. Secondary Outcome

Title	Amount of Rescue Medication Taken
Description	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized.
Time Frame	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Week 1	3677.4 (5348.8)	3015.2 (4118.3)	2125.0 (3535.5)
Week 2	3419.4 (4949.9)	3515.2 (4752.4)	2467.7 (4106.8)
Week 3	2661.3 (4772.1)	2774.2 (4118.7)	3100.0 (4810.9)
Week 4	2851.9 (4598.9)	2387.1 (3874.5)	1733.3 (3109.3)
Week 5	2500.0 (4759.6)	1900.0 (3046.8)	1883.3 (3600.0)
Week 6	2960.0 (4964.3)	1827.6 (3282.2)	1810.3 (3100.7)
Week 7	2920.0 (5217.5)	1758.6 (3712.0)	1689.7 (3137.9)
Week 8	1770.8 (4175.4)	2303.6 (3432.8)	1517.9 (2447.5)
Week 9	1760.9 (4504.7)	2160.7 (3372.1)	1517.9 (2488.8)
Week 10	1847.8 (3767.2)	2339.3 (3768.9)	1759.3 (2693.9)
Week 11	1891.3 (3394.4)	2446.4 (3871.4)	1666.7 (2609.2)
Week 12	2326.1 (4193.1)	2214.3 (3486.6)	1961.5 (3168.4)
Week 13	2590.9 (4371.5)	2142.9 (3042.5)	1400.0 (2594.1)
Week 14	2285.7 (3477.0)	1821.4 (2385.2)	1160.0 (2330.6)
Week 15	1595.2 (3084.7)	2129.6 (3142.7)	1854.2 (2826.4)
Week 16	916.7 (1759.4)	1870.4 (2475.2)	2065.2 (3145.4)

20. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Baseline up to 112 days after the last dose of study drug (up to Week 16)

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
AEs	20 64.5%	24 72.7%	21 65.6%
SAEs	1 3.2%	2 6.1%	1 3.1%

21. Secondary Outcome

Title	Number of Participants With Abnormal Physical Examinations Findings at Screening
Description	Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion.
Time Frame	Screening visit (1 day prior to Day 1 baseline visit)

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, "number analyzed" signifies those participants who were evaluable for specified categories.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Abdomen	0 0%	3 9.1%	1 3.1%
Ear	0 0%	1 3%	2 6.3%
Extremities	2 6.5%	5 15.2%	4 12.5%
Eyes	1 3.2%	4 12.1%	0 0%
General	0 0%	0 0%	0 0%
Head	2 6.5%	0 0%	3 9.4%
Heart	1 3.2%	3 9.1%	1 3.1%
Lungs	0 0%	0 0%	2 6.3%
Musculoskeletal	1 3.2%	3 9.1%	4 12.5%
Neck	0 0%	2 6.1%	1 3.1%
Nose	1 3.2%	1 3%	0 0%
Skin	10 32.3%	10 30.3%	10 31.3%
Throat	0 0%	0 0%	0 0%
Thyroid	0 0%	1 3%	1 3.1%

22. Secondary Outcome

Title	Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16
Description	Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	30	32	31
Count of Participants [Participants]	1 3.2%	3 9.1%	1 3.1%

23. Secondary Outcome

Title	Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16
Description	Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation).
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	32	32
Count of Participants [Participants]	1 3.2%	0 0%	0 0%

24. Secondary Outcome

Title	Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16
Description	Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (<) 40 beats per minute and greater than (>) 150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion).

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Count of Participants [Participants]	0 0%	0 0%	0 0%

25. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3ULN), electrolytes (sodium <0.95 LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6LLN, >1.5ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	32	32
Count of Participants [Participants]	22 71%	25 75.8%	20 62.5%

26. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities
Description	Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	30	33	32
Count of Participants [Participants]	0 0%	0 0%	0 0%

27. Secondary Outcome

Title	Number of Participants With Positive Anti-Drug Antibody (ADA) Response
Description	Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for PF-04383119 were considered as ADA positive.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Data for this outcome measure was not planned to be assessed collected and reported only for Tanezumab 50, 200 mcg/kg reporting group, not for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	33	32
Count of Participants [Participants]	0 0%	0 0%

28. Secondary Outcome

Title	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study
Description	HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall.
Time Frame	Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)

Outcome Measure Data

Analysis Population Description
Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, "number analyzed" signifies those participants who were evaluable at given time points.

Arm/Group Title	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	31	33	32
Baseline: TR	24.58 (3.59)	23.15 (5.28)	26.84 (5.54)
Change at Week 2: TR	-0.03 (4.31)	0.19 (3.73)	0.70 (4.20)
Change at Week 6: TR	1.50 (5.02)	0.83 (4.29)	1.08 (3.86)
Change at Week 12: TR	2.18 (3.92)	1.35 (4.43)	1.56 (3.85)
Change at Week 16: TR	3.10 (4.35)	1.93 (4.58)	2.61 (3.43)
End of Study: TR	3.03 (4.35)	1.19 (4.71)	2.37 (3.68)
Baseline: DR	9.16 (2.34)	7.70 (2.48)	9.47 (2.55)
Change at Week 2: DR	-0.20 (2.34)	0.63 (1.96)	0.67 (1.42)
Change at Week 6: DR	0.09 (1.97)	0.86 (2.10)	0.85 (1.62)
Change at Week 12: DR	0.50 (1.95)	1.23 (2.29)	0.56 (1.87)
Change at Week 16: DR	1.10 (2.43)	1.81 (3.08)	1.09 (1.98)
Change at End of study: DR	0.71 (2.55)	1.69 (3.05)	0.77 (1.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.548
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 90% -1.81 to 1.56
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.02
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.117
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 90% -0.48 to 2.96
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.04
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.779
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) 90% -2.69 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.11
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.375
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 90% -1.52 to 2.25
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.14
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.881
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.36
	Confidence Interval	(2-Sided) 90% -3.26 to 0.54
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.15
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.636
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 90% -2.33 to 1.52
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.17
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.905
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.54
	Confidence Interval	(2-Sided) 90% -3.46 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.17
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.499
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90% -2.00 to 2.00
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.21
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.297
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 90% -0.56 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 90% 0.09 to 1.74
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.50
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 90% -0.48 to 1.31
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.54
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.069
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 90% -0.09 to 1.70
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.54
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.338
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 90% -0.68 to 1.15
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.55
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.381
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 90% -0.75 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 50 mcg/kg
	Comments	Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.306
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 90% -0.64 to 1.21
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.56
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tanezumab 200 mcg/kg
	Comments	Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.440
	Comments
	Method	Repeated Measures Model
	Comments	P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90% -0.87 to 1.04
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.58
	Estimation Comments

29. Secondary Outcome

Title	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab
Description	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time Frame	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	26	26
Mean (Standard Deviation) [nanogramhour per milliliter (nghr/mL)]	843814.9 (514324.95)	2559793.7 (1332736.95)

30. Other Pre-specified Outcome

Title	Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab
Description	Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Time Frame	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	32	30
Mean (Standard Deviation) [ng*hr/mL]	873666.5 (963283.79)	2242378.0 (1128330.22)

31. Other Pre-specified Outcome

Title	Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose
Description	Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported.
Time Frame	1, 2688 hours postdose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	33	32
C1	2101.8 (1765.97)	6861.6 (4885.51)
C2688	101.810 (325.241)	170.984 (241.639)

32. Other Pre-specified Outcome

Title	Total Clearance of Tanezumab From Plasma
Description	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time Frame	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	26	26
Mean (Standard Deviation) [milliliter per hour per kilogram]	0.082 (0.053)	0.093 (0.042)

33. Other Pre-specified Outcome

Title	Terminal Elimination Half-Life (t1/2) of Tanezumab
Description	Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration.
Time Frame	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	26	26
Mean (Standard Deviation) [days]	18.92 (4.889)	22.76 (7.336)

34. Other Pre-specified Outcome

Title	Volume of Distribution at Steady State (Vss) for Tanezumab
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time Frame	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed placebo group.

Arm/Group Title	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
Measure Participants	26	26
Mean (Standard Deviation) [milliliter per kilogram]	47.03 (22.334)	65.96 (18.785)

Adverse Events

	Placebo		Tanezumab 50 mcg/kg		Tanezumab 200 mcg/kg
Time Frame
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Arm/Group Title	Placebo		Tanezumab 50 mcg/kg		Tanezumab 200 mcg/kg
Arm/Group Description	Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).		Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).		Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tanezumab 50 mcg/kg		Tanezumab 200 mcg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/31 (3.2%)		2/33 (6.1%)		1/32 (3.1%)
Blood and lymphatic system disorders
Anaemia	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Cardiac disorders
Myocardial infarction	0/31 (0%)		1/33 (3%)		0/32 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Infections and infestations
Cellulitis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Other (Not Including Serious) Adverse Events
	Placebo		Tanezumab 50 mcg/kg		Tanezumab 200 mcg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/31 (64.5%)		24/33 (72.7%)		21/32 (65.6%)
Blood and lymphatic system disorders
Anaemia	1/31 (3.2%)		1/33 (3%)		0/32 (0%)
Cardiac disorders
Cardiac failure congestive	0/31 (0%)		1/33 (3%)		0/32 (0%)
Eye disorders
Conjunctivitis	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Visual acuity reduced	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Gastrointestinal disorders
Abdominal pain	2/31 (6.5%)		1/33 (3%)		0/32 (0%)
Abdominal pain upper	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Colonic polyp	0/31 (0%)		1/33 (3%)		0/32 (0%)
Constipation	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Crohn's disease	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Diarrhoea	0/31 (0%)		2/33 (6.1%)		2/32 (6.3%)
Diverticulum	0/31 (0%)		1/33 (3%)		0/32 (0%)
Gastritis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Haemorrhoids	0/31 (0%)		1/33 (3%)		0/32 (0%)
Hiatus hernia	0/31 (0%)		1/33 (3%)		0/32 (0%)
Nausea	1/31 (3.2%)		0/33 (0%)		1/32 (3.1%)
Paraesthesia oral	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Reflux oesophagitis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Toothache	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Vomiting	0/31 (0%)		1/33 (3%)		0/32 (0%)
General disorders
Asthenia	0/31 (0%)		1/33 (3%)		0/32 (0%)
Malaise	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Hepatobiliary disorders
Cholelithiasis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Immune system disorders
Seasonal allergy	0/31 (0%)		2/33 (6.1%)		0/32 (0%)
Infections and infestations
Body tinea	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Bronchitis	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Cystitis	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Herpes simplex	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Herpes zoster	1/31 (3.2%)		1/33 (3%)		0/32 (0%)
Influenza	1/31 (3.2%)		0/33 (0%)		1/32 (3.1%)
Mastitis	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Oral herpes	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Oropharyngeal candidiasis	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Sinusitis	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Tooth abscess	0/31 (0%)		0/33 (0%)		2/32 (6.3%)
Upper respiratory tract infection	0/31 (0%)		0/33 (0%)		2/32 (6.3%)
Urinary tract infection	1/31 (3.2%)		2/33 (6.1%)		3/32 (9.4%)
Viral infection	0/31 (0%)		0/33 (0%)		2/32 (6.3%)
Viral upper respiratory tract infection	0/31 (0%)		1/33 (3%)		0/32 (0%)
Injury, poisoning and procedural complications
Arthropod sting	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Contusion	1/31 (3.2%)		0/33 (0%)		1/32 (3.1%)
Fall	0/31 (0%)		2/33 (6.1%)		0/32 (0%)
Joint sprain	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Muscle strain	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Skin laceration	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Tendon rupture	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Thermal burn	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Investigations
Alanine aminotransferase increased	0/31 (0%)		1/33 (3%)		0/32 (0%)
Aspartate aminotransferase increased	0/31 (0%)		1/33 (3%)		0/32 (0%)
Blood alkaline phosphatase increased	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Blood creatine phosphokinase abnormal	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Blood creatine phosphokinase increased	1/31 (3.2%)		1/33 (3%)		0/32 (0%)
Blood glucose increased	0/31 (0%)		1/33 (3%)		0/32 (0%)
Blood lactate dehydrogenase increased	0/31 (0%)		1/33 (3%)		0/32 (0%)
Blood pressure increased	2/31 (6.5%)		0/33 (0%)		0/32 (0%)
Blood triglycerides increased	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Gamma-glutamyltransferase increased	0/31 (0%)		1/33 (3%)		0/32 (0%)
Metabolism and nutrition disorders
Anorexia	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Gout	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Hyponatraemia	0/31 (0%)		1/33 (3%)		0/32 (0%)
Increased appetite	0/31 (0%)		1/33 (3%)		0/32 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/31 (0%)		2/33 (6.1%)		1/32 (3.1%)
Bursitis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Intervertebral disc protrusion	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Muscle fatigue	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Muscle spasms	0/31 (0%)		1/33 (3%)		0/32 (0%)
Musculoskeletal chest pain	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Musculoskeletal stiffness	1/31 (3.2%)		1/33 (3%)		0/32 (0%)
Neck pain	0/31 (0%)		1/33 (3%)		0/32 (0%)
Osteoarthritis	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Pain in extremity	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Plantar fasciitis	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Nervous system disorders
Carpal tunnel syndrome	0/31 (0%)		1/33 (3%)		0/32 (0%)
Dizziness	1/31 (3.2%)		2/33 (6.1%)		0/32 (0%)
Dysaesthesia	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Headache	0/31 (0%)		2/33 (6.1%)		4/32 (12.5%)
Hyperaesthesia	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Hypoaesthesia	0/31 (0%)		1/33 (3%)		1/32 (3.1%)
Intention tremor	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Paraesthesia	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Post herpetic neuralgia	0/31 (0%)		1/33 (3%)		3/32 (9.4%)
Presyncope	0/31 (0%)		1/33 (3%)		0/32 (0%)
Psychiatric disorders
Anxiety	0/31 (0%)		1/33 (3%)		0/32 (0%)
Insomnia	0/31 (0%)		2/33 (6.1%)		0/32 (0%)
Reproductive system and breast disorders
Erectile dysfunction	0/31 (0%)		1/33 (3%)		0/32 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/31 (3.2%)		1/33 (3%)		2/32 (6.3%)
Epistaxis	0/31 (0%)		1/33 (3%)		0/32 (0%)
Nasal congestion	1/31 (3.2%)		0/33 (0%)		1/32 (3.1%)
Oropharyngeal pain	0/31 (0%)		0/33 (0%)		2/32 (6.3%)
Pulmonary congestion	1/31 (3.2%)		1/33 (3%)		1/32 (3.1%)
Sinus congestion	0/31 (0%)		1/33 (3%)		0/32 (0%)
Throat irritation	0/31 (0%)		0/33 (0%)		1/32 (3.1%)
Skin and subcutaneous tissue disorders
Actinic keratosis	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Dermatitis contact	0/31 (0%)		1/33 (3%)		0/32 (0%)
Pruritus	1/31 (3.2%)		0/33 (0%)		0/32 (0%)
Rash papular	0/31 (0%)		1/33 (3%)		0/32 (0%)
Skin irritation	0/31 (0%)		1/33 (3%)		0/32 (0%)
Surgical and medical procedures
Cataract operation	0/31 (0%)		1/33 (3%)		0/32 (0%)
Vascular disorders
Flushing	1/31 (3.2%)		0/33 (0%)		1/32 (3.1%)
Hypertension	2/31 (6.5%)		1/33 (3%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00568321

Other Study ID Numbers:

A4091005
PHN POC

First Posted:

Dec 6, 2007

Last Update Posted:

May 28, 2021

Last Verified:

Feb 1, 2021