RN624 For Pain Of Post-Herpetic Neuralgia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568321

Enrollment

Registered

2007-12-06

Start date

2007-12-19

Completion date

2009-01-07

Last updated

2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia, Postherpetic

Keywords

monoclonal antibody

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).

Interventions

DRUGRN624

50 mcg/kg

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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.

Other

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1).	31
Tanezumab 50 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1).	33
Tanezumab 200 mcg/kg Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1).	32
Total	96

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	0	0
Overall Study	Lack of Efficacy	8	5	6
Overall Study	Lost to Follow-up	0	0	1
Overall Study	Protocol Violation	0	0	1
Overall Study	Randomized, not treated	2	0	1
Overall Study	Withdrawal by Subject	2	0	0

Baseline characteristics

Characteristic	Placebo	Tanezumab 50 mcg/kg	Tanezumab 200 mcg/kg	Total
Age, Continuous	70.9 years STANDARD_DEVIATION 8.7	71.9 years STANDARD_DEVIATION 8.5	65.9 years STANDARD_DEVIATION 14.6	69.6 years STANDARD_DEVIATION 11.2
Sex: Female, Male Female	13 Participants	16 Participants	15 Participants	44 Participants
Sex: Female, Male Male	18 Participants	17 Participants	17 Participants	52 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	20 / 31	24 / 33	21 / 32
serious Total, serious adverse events	1 / 31	2 / 33	1 / 32

Outcome results

Primary

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at 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.

Time frame: Baseline, Week 6

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Baseline	6.40 units on a scale	Standard Deviation 1.55
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Change at Week 6	-1.22 units on a scale	Standard Deviation 1.72
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Baseline	6.42 units on a scale	Standard Deviation 1.57
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Change at Week 6	-0.97 units on a scale	Standard Deviation 1.2
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Baseline	6.39 units on a scale	Standard Deviation 1.58
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Change at Week 6	-1.72 units on a scale	Standard Deviation 2.4

Comparison: 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.p-value: 0.68790% CI: [-0.5, 0.92]Repeated Measures Model

Comparison: 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.p-value: 0.11190% CI: [-1.25, 0.19]Repeated Measures Model

Secondary

Amount of Rescue Medication Taken

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	Amount of Rescue Medication Taken	Week 5	2500.0 milligram	Standard Deviation 4759.6
Placebo	Amount of Rescue Medication Taken	Week 1	3677.4 milligram	Standard Deviation 5348.8
Placebo	Amount of Rescue Medication Taken	Week 13	2590.9 milligram	Standard Deviation 4371.5
Placebo	Amount of Rescue Medication Taken	Week 6	2960.0 milligram	Standard Deviation 4964.3
Placebo	Amount of Rescue Medication Taken	Week 15	1595.2 milligram	Standard Deviation 3084.7
Placebo	Amount of Rescue Medication Taken	Week 2	3419.4 milligram	Standard Deviation 4949.9
Placebo	Amount of Rescue Medication Taken	Week 7	2920.0 milligram	Standard Deviation 5217.5
Placebo	Amount of Rescue Medication Taken	Week 12	2326.1 milligram	Standard Deviation 4193.1
Placebo	Amount of Rescue Medication Taken	Week 4	2851.9 milligram	Standard Deviation 4598.9
Placebo	Amount of Rescue Medication Taken	Week 8	1770.8 milligram	Standard Deviation 4175.4
Placebo	Amount of Rescue Medication Taken	Week 16	916.7 milligram	Standard Deviation 1759.4
Placebo	Amount of Rescue Medication Taken	Week 11	1891.3 milligram	Standard Deviation 3394.4
Placebo	Amount of Rescue Medication Taken	Week 3	2661.3 milligram	Standard Deviation 4772.1
Placebo	Amount of Rescue Medication Taken	Week 10	1847.8 milligram	Standard Deviation 3767.2
Placebo	Amount of Rescue Medication Taken	Week 14	2285.7 milligram	Standard Deviation 3477
Placebo	Amount of Rescue Medication Taken	Week 9	1760.9 milligram	Standard Deviation 4504.7
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 11	2446.4 milligram	Standard Deviation 3871.4
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 12	2214.3 milligram	Standard Deviation 3486.6
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 13	2142.9 milligram	Standard Deviation 3042.5
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 14	1821.4 milligram	Standard Deviation 2385.2
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 4	2387.1 milligram	Standard Deviation 3874.5
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 15	2129.6 milligram	Standard Deviation 3142.7
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 1	3015.2 milligram	Standard Deviation 4118.3
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 16	1870.4 milligram	Standard Deviation 2475.2
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 5	1900.0 milligram	Standard Deviation 3046.8
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 9	2160.7 milligram	Standard Deviation 3372.1
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 6	1827.6 milligram	Standard Deviation 3282.2
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 7	1758.6 milligram	Standard Deviation 3712
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 2	3515.2 milligram	Standard Deviation 4752.4
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 8	2303.6 milligram	Standard Deviation 3432.8
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 10	2339.3 milligram	Standard Deviation 3768.9
Tanezumab 50 mcg/kg	Amount of Rescue Medication Taken	Week 3	2774.2 milligram	Standard Deviation 4118.7
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 16	2065.2 milligram	Standard Deviation 3145.4
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 10	1759.3 milligram	Standard Deviation 2693.9
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 1	2125.0 milligram	Standard Deviation 3535.5
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 2	2467.7 milligram	Standard Deviation 4106.8
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 3	3100.0 milligram	Standard Deviation 4810.9
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 4	1733.3 milligram	Standard Deviation 3109.3
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 5	1883.3 milligram	Standard Deviation 3600
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 6	1810.3 milligram	Standard Deviation 3100.7
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 7	1689.7 milligram	Standard Deviation 3137.9
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 8	1517.9 milligram	Standard Deviation 2447.5
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 9	1517.9 milligram	Standard Deviation 2488.8
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 11	1666.7 milligram	Standard Deviation 2609.2
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 12	1961.5 milligram	Standard Deviation 3168.4
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 13	1400.0 milligram	Standard Deviation 2594.1
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 14	1160.0 milligram	Standard Deviation 2330.6
Tanezumab 200 mcg/kg	Amount of Rescue Medication Taken	Week 15	1854.2 milligram	Standard Deviation 2826.4

Secondary

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab

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

Population: 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	Measure	Value (MEAN)	Dispersion
Placebo	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab	843814.9 nanogramhour per milliliter (nghr/mL)	Standard Deviation 514324.95
Tanezumab 50 mcg/kg	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab	2559793.7 nanogramhour per milliliter (nghr/mL)	Standard Deviation 1332736.95

Secondary

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 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.

Time frame: Baseline, Week 1, 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 1	-0.54 units on a scale	Standard Deviation 1.25
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 2	-0.80 units on a scale	Standard Deviation 1.65
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 4	-1.30 units on a scale	Standard Deviation 1.61
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 8	-1.18 units on a scale	Standard Deviation 1.47
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 12	-1.13 units on a scale	Standard Deviation 1.46
Placebo	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 16	-1.18 units on a scale	Standard Deviation 1.61
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 16	-1.70 units on a scale	Standard Deviation 1.78
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 1	-0.64 units on a scale	Standard Deviation 1.19
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 8	-1.10 units on a scale	Standard Deviation 1.36
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 12	-1.49 units on a scale	Standard Deviation 1.66
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 2	-0.46 units on a scale	Standard Deviation 1.42
Tanezumab 50 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 4	-0.97 units on a scale	Standard Deviation 1.15
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 2	-0.66 units on a scale	Standard Deviation 1.73
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 4	-1.46 units on a scale	Standard Deviation 1.91
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 16	-1.76 units on a scale	Standard Deviation 2.47
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 8	-1.72 units on a scale	Standard Deviation 2.34
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 1	-0.91 units on a scale	Standard Deviation 1.36
Tanezumab 200 mcg/kg	Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Change at Week 12	-1.45 units on a scale	Standard Deviation 2.44

Comparison: 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.p-value: 0.39990% CI: [-0.79, 0.58]Repeated Measures Model

Comparison: 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.p-value: 0.80290% CI: [-0.33, 1.04]Repeated Measures Model

Comparison: 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.p-value: 0.78990% CI: [-0.36, 1.04]Repeated Measures Model

Comparison: 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.p-value: 0.56890% CI: [-0.65, 0.81]Repeated Measures Model

Comparison: 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.p-value: 0.21890% CI: [-1.11, 0.4]Repeated Measures Model

Comparison: 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.p-value: 0.25290% CI: [-1.11, 0.47]Repeated Measures Model

Secondary

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	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	Weeks 1 to 8	-0.97 units on a scale	Standard Deviation 1.37
Placebo	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	Weeks 5 to 8	-1.18 units on a scale	Standard Deviation 1.5
Placebo	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	Weeks 1 to 16	-1.02 units on a scale	Standard Deviation 1.17
Placebo	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	Weeks 1 to 4	-0.87 units on a scale	Standard Deviation 1.43
Placebo	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	Weeks 5 to 16	-1.19 units on a scale	Standard Deviation 1.27
Placebo	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	Weeks 5 to 12	-1.19 units on a scale	Standard Deviation 1.34
Placebo	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	Weeks 1 to 12	-1.01 units on a scale	Standard Deviation 1.25
Tanezumab 50 mcg/kg	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	Weeks 1 to 16	-1.03 units on a scale	Standard Deviation 1.16
Tanezumab 50 mcg/kg	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	Weeks 1 to 4	-0.70 units on a scale	Standard Deviation 1.13
Tanezumab 50 mcg/kg	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	Weeks 1 to 8	-0.81 units on a scale	Standard Deviation 1.03
Tanezumab 50 mcg/kg	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	Weeks 1 to 12	-0.97 units on a scale	Standard Deviation 1.07
Tanezumab 50 mcg/kg	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	Weeks 5 to 8	-1.01 units on a scale	Standard Deviation 1.15
Tanezumab 50 mcg/kg	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	Weeks 5 to 12	-1.20 units on a scale	Standard Deviation 1.27
Tanezumab 50 mcg/kg	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	Weeks 5 to 16	-1.25 units on a scale	Standard Deviation 1.38
Tanezumab 200 mcg/kg	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	Weeks 5 to 8	-1.61 units on a scale	Standard Deviation 2.21
Tanezumab 200 mcg/kg	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	Weeks 1 to 8	-1.35 units on a scale	Standard Deviation 1.74
Tanezumab 200 mcg/kg	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	Weeks 5 to 16	-1.52 units on a scale	Standard Deviation 2.13
Tanezumab 200 mcg/kg	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	Weeks 5 to 12	-1.50 units on a scale	Standard Deviation 2.08
Tanezumab 200 mcg/kg	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	Weeks 1 to 16	-1.43 units on a scale	Standard Deviation 1.81
Tanezumab 200 mcg/kg	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	Weeks 1 to 12	-1.38 units on a scale	Standard Deviation 1.75
Tanezumab 200 mcg/kg	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	Weeks 1 to 4	-1.08 units on a scale	Standard Deviation 1.53

Comparison: 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.p-value: 0.68390% CI: [-0.46, 0.84]Repeated Measures Model

Comparison: 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.p-value: 0.66890% CI: [-0.46, 0.78]Repeated Measures Model

Comparison: 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.p-value: 0.54690% CI: [-0.55, 0.64]Repeated Measures Model

Comparison: 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.p-value: 0.46790% CI: [-0.6, 0.55]Repeated Measures Model

Comparison: 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.p-value: 0.63290% CI: [-0.54, 0.81]Repeated Measures Model

Comparison: 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.p-value: 0.46890% CI: [-0.68, 0.61]Repeated Measures Model

Comparison: 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.p-value: 0.39490% CI: [-0.72, 0.52]Repeated Measures Model

Secondary

Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study

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)

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: DR	-0.20 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: TR	2.18 units on a scale	Standard Deviation 3.92
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: DR	1.10 units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: TR	1.50 units on a scale	Standard Deviation 5.02
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: TR	3.10 units on a scale	Standard Deviation 4.35
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: DR	0.09 units on a scale	Standard Deviation 1.97
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at End of study: DR	0.71 units on a scale	Standard Deviation 2.55
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	End of Study: TR	3.03 units on a scale	Standard Deviation 4.35
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: DR	0.50 units on a scale	Standard Deviation 1.95
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: TR	24.58 units on a scale	Standard Deviation 3.59
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: DR	9.16 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: TR	-0.03 units on a scale	Standard Deviation 4.31
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: DR	7.70 units on a scale	Standard Deviation 2.48
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: DR	0.86 units on a scale	Standard Deviation 2.1
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: TR	0.19 units on a scale	Standard Deviation 3.73
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: DR	1.81 units on a scale	Standard Deviation 3.08
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: TR	0.83 units on a scale	Standard Deviation 4.29
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at End of study: DR	1.69 units on a scale	Standard Deviation 3.05
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: DR	0.63 units on a scale	Standard Deviation 1.96
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: TR	1.35 units on a scale	Standard Deviation 4.43
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: DR	1.23 units on a scale	Standard Deviation 2.29
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: TR	1.93 units on a scale	Standard Deviation 4.58
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	End of Study: TR	1.19 units on a scale	Standard Deviation 4.71
Tanezumab 50 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: TR	23.15 units on a scale	Standard Deviation 5.28
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at End of study: DR	0.77 units on a scale	Standard Deviation 1.92
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: TR	26.84 units on a scale	Standard Deviation 5.54
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: TR	0.70 units on a scale	Standard Deviation 4.2
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: TR	1.08 units on a scale	Standard Deviation 3.86
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: TR	1.56 units on a scale	Standard Deviation 3.85
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: TR	2.61 units on a scale	Standard Deviation 3.43
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	End of Study: TR	2.37 units on a scale	Standard Deviation 3.68
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Baseline: DR	9.47 units on a scale	Standard Deviation 2.55
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 2: DR	0.67 units on a scale	Standard Deviation 1.42
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 6: DR	0.85 units on a scale	Standard Deviation 1.62
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 12: DR	0.56 units on a scale	Standard Deviation 1.87
Tanezumab 200 mcg/kg	Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	Change at Week 16: DR	1.09 units on a scale	Standard Deviation 1.98

Comparison: 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.p-value: 0.54890% CI: [-1.81, 1.56]Repeated Measures Model

Comparison: 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.p-value: 0.77990% CI: [-2.69, 0.98]Repeated Measures Model

Comparison: 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.p-value: 0.88190% CI: [-3.26, 0.54]Repeated Measures Model

Comparison: 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.p-value: 0.90590% CI: [-3.46, 0.39]Repeated Measures Model

Comparison: 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.p-value: 0.29790% CI: [-0.56, 1.09]Repeated Measures Model

Comparison: 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.p-value: 0.22290% CI: [-0.48, 1.31]Repeated Measures Model

Comparison: 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.p-value: 0.33890% CI: [-0.68, 1.15]Repeated Measures Model

Comparison: 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.p-value: 0.30690% CI: [-0.64, 1.21]Repeated Measures Model

Secondary

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

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	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	Change at Week 1: Average Pain	-0.83 units on a scale	Standard Deviation 1.54
Placebo	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: Worst Pain	7.13 units on a scale	Standard Deviation 1.57
Placebo	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: Average Pain	6.27 units on a scale	Standard Deviation 1.46
Placebo	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: Pain Severity	24.77 units on a scale	Standard Deviation 6.43
Placebo	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	Change at Week 1: Worst Pain	-1.10 units on a scale	Standard Deviation 2.08
Placebo	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	Change at Week 1: Pain Severity	-3.59 units on a scale	Standard Deviation 7.06
Placebo	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	Change at Week 2: Worst Pain	-1.38 units on a scale	Standard Deviation 2.14
Placebo	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	Change at Week 2: Average Pain	-1.19 units on a scale	Standard Deviation 1.72
Placebo	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	Change at Week 2: Pain Severity	-5.31 units on a scale	Standard Deviation 7.17
Placebo	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	Change at Week 4: Worst Pain	-1.44 units on a scale	Standard Deviation 2.26
Placebo	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	Change at Week 4: Average Pain	-1.44 units on a scale	Standard Deviation 1.64
Placebo	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	Change at Week 4: Pain Severity	-5.68 units on a scale	Standard Deviation 7.4
Placebo	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	Change at Week 6: Worst Pain	-1.24 units on a scale	Standard Deviation 1.76
Placebo	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	Change at Week 6: Average Pain	-1.19 units on a scale	Standard Deviation 1.63
Placebo	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	Change at Week 6: Pain Severity	-4.57 units on a scale	Standard Deviation 5.81
Placebo	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	Change at Week 8: Worst Pain	-2.00 units on a scale	Standard Deviation 1.56
Placebo	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	Change at Week 8: Average Pain	-1.60 units on a scale	Standard Deviation 1.54
Placebo	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	Change at Week 8: Pain Severity	-7.60 units on a scale	Standard Deviation 5.22
Placebo	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	Change at Week 12: Worst Pain	-1.67 units on a scale	Standard Deviation 1.49
Placebo	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	Change at Week 12: Average Pain	-1.38 units on a scale	Standard Deviation 1.5
Placebo	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	Change at Week 12: Pain Severity	-5.76 units on a scale	Standard Deviation 6.03
Placebo	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	Change at Week 16: Worst Pain	-1.90 units on a scale	Standard Deviation 1.37
Placebo	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	Change at Week 16: Average Pain	-1.50 units on a scale	Standard Deviation 1.28
Placebo	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	Change at Week 16: Pain Severity	-6.40 units on a scale	Standard Deviation 4.91
Tanezumab 50 mcg/kg	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	Change at Week 16: Worst Pain	-1.63 units on a scale	Standard Deviation 2.26
Tanezumab 50 mcg/kg	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	Change at Week 8: Average Pain	-0.96 units on a scale	Standard Deviation 1.43
Tanezumab 50 mcg/kg	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: Worst Pain	6.78 units on a scale	Standard Deviation 1.79
Tanezumab 50 mcg/kg	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	Change at Week 6: Worst Pain	-0.93 units on a scale	Standard Deviation 1.57
Tanezumab 50 mcg/kg	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	Change at Week 4: Average Pain	-0.75 units on a scale	Standard Deviation 1.04
Tanezumab 50 mcg/kg	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: Average Pain	6.06 units on a scale	Standard Deviation 1.72
Tanezumab 50 mcg/kg	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	Change at Week 12: Pain Severity	-5.83 units on a scale	Standard Deviation 7.24
Tanezumab 50 mcg/kg	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	Change at Week 6: Average Pain	-0.78 units on a scale	Standard Deviation 1.34
Tanezumab 50 mcg/kg	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: Pain Severity	23.78 units on a scale	Standard Deviation 7.23
Tanezumab 50 mcg/kg	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	Change at Week 16: Average Pain	-1.25 units on a scale	Standard Deviation 1.78
Tanezumab 50 mcg/kg	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	Change at Week 8: Pain Severity	-5.04 units on a scale	Standard Deviation 5.78
Tanezumab 50 mcg/kg	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	Change at Week 1: Worst Pain	-0.57 units on a scale	Standard Deviation 2.22
Tanezumab 50 mcg/kg	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	Change at Week 4: Worst Pain	-0.93 units on a scale	Standard Deviation 1.15
Tanezumab 50 mcg/kg	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	Change at Week 1: Average Pain	-0.46 units on a scale	Standard Deviation 1.43
Tanezumab 50 mcg/kg	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	Change at Week 6: Pain Severity	-4.07 units on a scale	Standard Deviation 4.95
Tanezumab 50 mcg/kg	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	Change at Week 4: Pain Severity	-3.82 units on a scale	Standard Deviation 4.26
Tanezumab 50 mcg/kg	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	Change at Week 1: Pain Severity	-1.82 units on a scale	Standard Deviation 6.42
Tanezumab 50 mcg/kg	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	Change at Week 2: Pain Severity	-1.86 units on a scale	Standard Deviation 5.88
Tanezumab 50 mcg/kg	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	Change at Week 16: Pain Severity	-6.17 units on a scale	Standard Deviation 7.95
Tanezumab 50 mcg/kg	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	Change at Week 2: Worst Pain	-0.52 units on a scale	Standard Deviation 1.92
Tanezumab 50 mcg/kg	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	Change at Week 8: Worst Pain	-1.26 units on a scale	Standard Deviation 2.09
Tanezumab 50 mcg/kg	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	Change at Week 12: Worst Pain	-1.50 units on a scale	Standard Deviation 2.09
Tanezumab 50 mcg/kg	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	Change at Week 2: Average Pain	-0.41 units on a scale	Standard Deviation 1.18
Tanezumab 50 mcg/kg	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	Change at Week 12: Average Pain	-1.17 units on a scale	Standard Deviation 1.49
Tanezumab 200 mcg/kg	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	Change at Week 2: Average Pain	-0.85 units on a scale	Standard Deviation 2.24
Tanezumab 200 mcg/kg	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	Change at Week 2: Pain Severity	-3.58 units on a scale	Standard Deviation 9.38
Tanezumab 200 mcg/kg	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	Change at Week 4: Worst Pain	-1.18 units on a scale	Standard Deviation 2.21
Tanezumab 200 mcg/kg	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	Change at Week 4: Average Pain	-1.39 units on a scale	Standard Deviation 2.11
Tanezumab 200 mcg/kg	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	Change at Week 12: Average Pain	-1.56 units on a scale	Standard Deviation 2.45
Tanezumab 200 mcg/kg	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	Change at Week 4: Pain Severity	-5.21 units on a scale	Standard Deviation 8.8
Tanezumab 200 mcg/kg	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	Change at Week 16: Average Pain	-1.95 units on a scale	Standard Deviation 2.62
Tanezumab 200 mcg/kg	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	Change at Week 6: Worst Pain	-1.76 units on a scale	Standard Deviation 2.74
Tanezumab 200 mcg/kg	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	Change at Week 6: Average Pain	-1.72 units on a scale	Standard Deviation 2.39
Tanezumab 200 mcg/kg	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	Change at Week 12: Pain Severity	-5.60 units on a scale	Standard Deviation 10.38
Tanezumab 200 mcg/kg	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	Change at Week 6: Pain Severity	-7.00 units on a scale	Standard Deviation 10.39
Tanezumab 200 mcg/kg	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	Change at Week 16: Pain Severity	-8.38 units on a scale	Standard Deviation 10.21
Tanezumab 200 mcg/kg	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	Change at Week 8: Worst Pain	-1.81 units on a scale	Standard Deviation 3.16
Tanezumab 200 mcg/kg	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: Worst Pain	6.93 units on a scale	Standard Deviation 1.48
Tanezumab 200 mcg/kg	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	Change at Week 8: Average Pain	-1.77 units on a scale	Standard Deviation 2.44
Tanezumab 200 mcg/kg	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: Average Pain	6.20 units on a scale	Standard Deviation 1.58
Tanezumab 200 mcg/kg	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	Change at Week 16: Worst Pain	-2.38 units on a scale	Standard Deviation 3.06
Tanezumab 200 mcg/kg	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: Pain Severity	23.87 units on a scale	Standard Deviation 5.9
Tanezumab 200 mcg/kg	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	Change at Week 1: Worst Pain	-0.71 units on a scale	Standard Deviation 1.58
Tanezumab 200 mcg/kg	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	Change at Week 1: Average Pain	-0.79 units on a scale	Standard Deviation 1.55
Tanezumab 200 mcg/kg	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	Change at Week 8: Pain Severity	-6.65 units on a scale	Standard Deviation 10.55
Tanezumab 200 mcg/kg	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	Change at Week 1: Pain Severity	-2.79 units on a scale	Standard Deviation 6.64
Tanezumab 200 mcg/kg	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	Change at Week 2: Worst Pain	-0.96 units on a scale	Standard Deviation 2.51
Tanezumab 200 mcg/kg	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	Change at Week 12: Worst Pain	-1.64 units on a scale	Standard Deviation 3.28

Comparison: 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.p-value: 0.76490% CI: [-0.51, 1.3]Repeated Measures Model

Comparison: 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.p-value: 0.73490% CI: [-0.46, 1.03]Repeated Measures Model

Comparison: 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.p-value: 0.76590% CI: [-1.76, 4.5]Repeated Measures Model

Comparison: 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.p-value: 0.89590% CI: [-0.22, 1.6]Repeated Measures Model

Comparison: 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.p-value: 0.94490% CI: [-0.03, 1.47]Repeated Measures Model

Comparison: 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.p-value: 0.95590% CI: [0.09, 6.37]Repeated Measures Model

Comparison: 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.p-value: 0.73790% CI: [-0.57, 1.28]Repeated Measures Model

Comparison: 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.p-value: 0.92590% CI: [-0.1, 1.43]Repeated Measures Model

Comparison: 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.p-value: 0.8190% CI: [-1.49, 4.88]Repeated Measures Model

Comparison: 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.p-value: 0.65190% CI: [-0.73, 1.18]Repeated Measures Model

Comparison: 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.p-value: 0.76890% CI: [-0.44, 1.14]Repeated Measures Model

Comparison: 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.p-value: 0.6190% CI: [-2.73, 3.85]Repeated Measures Model

Comparison: 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.p-value: 0.78990% CI: [-0.5, 1.45]Repeated Measures Model

Comparison: 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.p-value: 0.78290% CI: [-0.43, 1.19]Repeated Measures Model

Comparison: 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.p-value: 0.80490% CI: [-1.62, 5.11]Repeated Measures Model

Comparison: 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.p-value: 0.40990% CI: [-1.13, 0.86]Repeated Measures Model

Comparison: 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.p-value: 0.59290% CI: [-0.71, 0.94]Repeated Measures Model

Comparison: 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.p-value: 0.39690% CI: [-3.98, 2.88]Repeated Measures Model

Comparison: 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.p-value: 0.48690% CI: [-1.04, 1]Repeated Measures Model

Comparison: 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.p-value: 0.56390% CI: [-0.76, 0.92]Repeated Measures Model

Comparison: 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.p-value: 0.40990% CI: [-3.99, 3.01]Repeated Measures Model

Secondary

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	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	Change at Week 2: CS	-1.47 units on a scale	Standard Deviation 2.18
Placebo	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: GA	4.13 units on a scale	Standard Deviation 2.75
Placebo	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: NW	3.53 units on a scale	Standard Deviation 2.66
Placebo	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	Change at Week 1: CS	-0.86 units on a scale	Standard Deviation 2.56
Placebo	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	Change at Week 1: GA	-0.76 units on a scale	Standard Deviation 3.12
Placebo	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	Change at Week 1: NW	-0.48 units on a scale	Standard Deviation 2.86
Placebo	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: CS	3.87 units on a scale	Standard Deviation 2.29
Placebo	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	Change at Week 2: GA	-1.58 units on a scale	Standard Deviation 2.84
Placebo	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	Change at Week 2: NW	-1.19 units on a scale	Standard Deviation 2.76
Placebo	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	Change at Week 4: CS	-1.22 units on a scale	Standard Deviation 1.98
Placebo	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	Change at Week 4: GA	-1.28 units on a scale	Standard Deviation 2.61
Placebo	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	Change at Week 4: NW	-1.04 units on a scale	Standard Deviation 2.09
Placebo	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	Change at Week 6: CS	-1.01 units on a scale	Standard Deviation 1.6
Placebo	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	Change at Week 6: GA	-1.05 units on a scale	Standard Deviation 2.18
Placebo	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	Change at Week 6: NW	-0.62 units on a scale	Standard Deviation 2.18
Placebo	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	Change at Week 8: CS	-1.37 units on a scale	Standard Deviation 1.75
Placebo	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	Change at Week 8: GA	-1.55 units on a scale	Standard Deviation 2.28
Placebo	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	Change at Week 8: NW	-1.10 units on a scale	Standard Deviation 2.13
Placebo	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	Change at Week 12: CS	-0.89 units on a scale	Standard Deviation 1.69
Placebo	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	Change at Week 12: GA	-0.86 units on a scale	Standard Deviation 2.54
Placebo	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	Change at Week 12: NW	-0.52 units on a scale	Standard Deviation 2.34
Placebo	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	Change at Week 16: CS	-1.46 units on a scale	Standard Deviation 1.21
Placebo	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	Change at Week 16: GA	-1.40 units on a scale	Standard Deviation 1.82
Placebo	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	Change at Week 16: NW	-1.30 units on a scale	Standard Deviation 1.78
Tanezumab 50 mcg/kg	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	Change at Week 16: CS	-1.23 units on a scale	Standard Deviation 2.02
Tanezumab 50 mcg/kg	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: CS	3.90 units on a scale	Standard Deviation 2.46
Tanezumab 50 mcg/kg	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	Change at Week 6: CS	-1.20 units on a scale	Standard Deviation 1.57
Tanezumab 50 mcg/kg	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	Change at Week 8: GA	-1.04 units on a scale	Standard Deviation 2.17
Tanezumab 50 mcg/kg	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: GA	4.16 units on a scale	Standard Deviation 3.09
Tanezumab 50 mcg/kg	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	Change at Week 4: GA	-1.18 units on a scale	Standard Deviation 2.45
Tanezumab 50 mcg/kg	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	Change at Week 12: NW	-1.00 units on a scale	Standard Deviation 2.21
Tanezumab 50 mcg/kg	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: NW	3.75 units on a scale	Standard Deviation 2.93
Tanezumab 50 mcg/kg	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	Change at Week 6: GA	-1.04 units on a scale	Standard Deviation 2.14
Tanezumab 50 mcg/kg	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	Change at Week 16: GA	-1.21 units on a scale	Standard Deviation 2.21
Tanezumab 50 mcg/kg	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	Change at Week 1: CS	-0.90 units on a scale	Standard Deviation 1.24
Tanezumab 50 mcg/kg	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	Change at Week 4: CS	-1.26 units on a scale	Standard Deviation 1.66
Tanezumab 50 mcg/kg	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	Change at Week 8: NW	-0.96 units on a scale	Standard Deviation 2.23
Tanezumab 50 mcg/kg	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	Change at Week 1: GA	-0.57 units on a scale	Standard Deviation 2.04
Tanezumab 50 mcg/kg	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	Change at Week 6: NW	-1.15 units on a scale	Standard Deviation 2.03
Tanezumab 50 mcg/kg	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	Change at Week 4: NW	-1.29 units on a scale	Standard Deviation 1.98
Tanezumab 50 mcg/kg	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	Change at Week 1: NW	-1.07 units on a scale	Standard Deviation 1.36
Tanezumab 50 mcg/kg	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	Change at Week 2: NW	-0.59 units on a scale	Standard Deviation 2.13
Tanezumab 50 mcg/kg	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	Change at Week 16: NW	-1.21 units on a scale	Standard Deviation 2.26
Tanezumab 50 mcg/kg	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	Change at Week 2: CS	-0.69 units on a scale	Standard Deviation 1.65
Tanezumab 50 mcg/kg	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	Change at Week 8: CS	-1.11 units on a scale	Standard Deviation 1.83
Tanezumab 50 mcg/kg	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	Change at Week 12: CS	-1.07 units on a scale	Standard Deviation 2.04
Tanezumab 50 mcg/kg	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	Change at Week 2: GA	-0.55 units on a scale	Standard Deviation 2.29
Tanezumab 50 mcg/kg	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	Change at Week 12: GA	-0.92 units on a scale	Standard Deviation 2.36
Tanezumab 200 mcg/kg	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	Change at Week 2: GA	-1.04 units on a scale	Standard Deviation 3.49
Tanezumab 200 mcg/kg	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	Change at Week 2: NW	-1.40 units on a scale	Standard Deviation 2.68
Tanezumab 200 mcg/kg	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	Change at Week 4: CS	-1.54 units on a scale	Standard Deviation 2.46
Tanezumab 200 mcg/kg	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	Change at Week 4: GA	-1.57 units on a scale	Standard Deviation 3.35
Tanezumab 200 mcg/kg	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	Change at Week 12: GA	-0.92 units on a scale	Standard Deviation 4.08
Tanezumab 200 mcg/kg	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	Change at Week 4: NW	-1.63 units on a scale	Standard Deviation 2.71
Tanezumab 200 mcg/kg	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	Change at Week 16: GA	-2.10 units on a scale	Standard Deviation 3.77
Tanezumab 200 mcg/kg	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	Change at Week 6: CS	-1.65 units on a scale	Standard Deviation 2.77
Tanezumab 200 mcg/kg	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	Change at Week 6: GA	-1.36 units on a scale	Standard Deviation 3.68
Tanezumab 200 mcg/kg	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	Change at Week 12: NW	-1.25 units on a scale	Standard Deviation 3.33
Tanezumab 200 mcg/kg	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	Change at Week 6: NW	-1.63 units on a scale	Standard Deviation 3.15
Tanezumab 200 mcg/kg	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	Change at Week 16: NW	-1.80 units on a scale	Standard Deviation 3.16
Tanezumab 200 mcg/kg	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	Change at Week 8: CS	-1.41 units on a scale	Standard Deviation 2.6
Tanezumab 200 mcg/kg	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: CS	4.67 units on a scale	Standard Deviation 2.05
Tanezumab 200 mcg/kg	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: GA	4.83 units on a scale	Standard Deviation 2.28
Tanezumab 200 mcg/kg	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	Change at Week 8: GA	-1.23 units on a scale	Standard Deviation 3.39
Tanezumab 200 mcg/kg	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: NW	5.00 units on a scale	Standard Deviation 2.56
Tanezumab 200 mcg/kg	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	Change at Week 16: CS	-1.82 units on a scale	Standard Deviation 3
Tanezumab 200 mcg/kg	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	Change at Week 1: CS	-0.99 units on a scale	Standard Deviation 2.28
Tanezumab 200 mcg/kg	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	Change at Week 1: GA	-1.14 units on a scale	Standard Deviation 2.86
Tanezumab 200 mcg/kg	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	Change at Week 8: NW	-1.52 units on a scale	Standard Deviation 2.76
Tanezumab 200 mcg/kg	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	Change at Week 1: NW	-1.48 units on a scale	Standard Deviation 2.56
Tanezumab 200 mcg/kg	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	Change at Week 2: CS	-1.23 units on a scale	Standard Deviation 2.67
Tanezumab 200 mcg/kg	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	Change at Week 12: CS	-1.25 units on a scale	Standard Deviation 3.25

Comparison: 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.p-value: 0.34390% CI: [-1.03, 0.62]Repeated Measures Model

Comparison: 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.p-value: 0.4690% CI: [-1.1, 0.98]Repeated Measures Model

Comparison: 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.p-value: 0.10490% CI: [-1.62, 0.22]Repeated Measures Model

Comparison: 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.p-value: 0.93190% CI: [-0.08, 1.58]Repeated Measures Model

Comparison: 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.p-value: 0.93690% CI: [-0.08, 2.01]Repeated Measures Model

Comparison: 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.p-value: 0.85590% CI: [-0.33, 1.51]Repeated Measures Model

Comparison: 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.p-value: 0.50490% CI: [-0.84, 0.85]Repeated Measures Model

Comparison: 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.p-value: 0.48690% CI: [-1.09, 1.04]Repeated Measures Model

Comparison: 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.p-value: 0.41890% CI: [-1.05, 0.82]Repeated Measures Model

Comparison: 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.p-value: 0.45690% CI: [-0.93, 0.81]Repeated Measures Model

Comparison: 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.p-value: 0.44890% CI: [-1.19, 1.02]Repeated Measures Model

Comparison: 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.p-value: 0.22590% CI: [-1.41, 0.52]Repeated Measures Model

Comparison: 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.p-value: 0.65790% CI: [-0.67, 1.11]Repeated Measures Model

Comparison: 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.p-value: 0.74290% CI: [-0.68, 1.57]Repeated Measures Model

Comparison: 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.p-value: 0.4990% CI: [-1.01, 0.98]Repeated Measures Model

Comparison: 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.p-value: 0.36290% CI: [-1.1, 0.71]Repeated Measures Model

Comparison: 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.p-value: 0.37690% CI: [-1.37, 0.93]Repeated Measures Model

Comparison: 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.p-value: 0.30390% CI: [-1.33, 0.69]Repeated Measures Model

Comparison: 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.p-value: 0.60990% CI: [-0.77, 1.08]Repeated Measures Model

Comparison: 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.p-value: 0.55690% CI: [-1.07, 1.27]Repeated Measures Model

Comparison: 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.p-value: 0.52790% CI: [-0.99, 1.07]Repeated Measures Model

Secondary

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

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	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	Change at Week 2	-1.96 units on a scale	Standard Deviation 2.68
Placebo	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	4.87 units on a scale	Standard Deviation 3.06
Placebo	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	Change at Week 4	-1.60 units on a scale	Standard Deviation 2.66
Placebo	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	Change at Week 12	-1.38 units on a scale	Standard Deviation 1.96
Placebo	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	Change at Week 1	-1.03 units on a scale	Standard Deviation 3.34
Placebo	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	Change at Week 6	-1.19 units on a scale	Standard Deviation 1.72
Placebo	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	Change at Week 16	-1.90 units on a scale	Standard Deviation 1.52
Placebo	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	Change at Week 8	-1.80 units on a scale	Standard Deviation 1.88
Tanezumab 50 mcg/kg	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	Change at Week 1	-1.50 units on a scale	Standard Deviation 2.2
Tanezumab 50 mcg/kg	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	Change at Week 8	-1.81 units on a scale	Standard Deviation 2.69
Tanezumab 50 mcg/kg	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	4.66 units on a scale	Standard Deviation 2.74
Tanezumab 50 mcg/kg	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	Change at Week 12	-1.63 units on a scale	Standard Deviation 2.83
Tanezumab 50 mcg/kg	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	Change at Week 16	-1.71 units on a scale	Standard Deviation 3.22
Tanezumab 50 mcg/kg	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	Change at Week 2	-1.03 units on a scale	Standard Deviation 2.78
Tanezumab 50 mcg/kg	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	Change at Week 4	-1.71 units on a scale	Standard Deviation 2.19
Tanezumab 50 mcg/kg	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	Change at Week 6	-1.85 units on a scale	Standard Deviation 2.23
Tanezumab 200 mcg/kg	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	Change at Week 16	-2.45 units on a scale	Standard Deviation 3.72
Tanezumab 200 mcg/kg	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	5.48 units on a scale	Standard Deviation 2.59
Tanezumab 200 mcg/kg	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	Change at Week 1	-1.37 units on a scale	Standard Deviation 3.21
Tanezumab 200 mcg/kg	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	Change at Week 2	-1.72 units on a scale	Standard Deviation 3.81
Tanezumab 200 mcg/kg	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	Change at Week 4	-2.04 units on a scale	Standard Deviation 3.13
Tanezumab 200 mcg/kg	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	Change at Week 6	-2.46 units on a scale	Standard Deviation 3.4
Tanezumab 200 mcg/kg	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	Change at Week 8	-2.16 units on a scale	Standard Deviation 3.41
Tanezumab 200 mcg/kg	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	Change at Week 12	-1.83 units on a scale	Standard Deviation 4.25

Comparison: 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.p-value: 0.24390% CI: [-1.58, 0.64]Repeated Measures Model

Secondary

Duration of Rescue Medication Use

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

Arm	Measure	Group	Value (MEDIAN)
Placebo	Duration of Rescue Medication Use	Week 12	0.00 days
Placebo	Duration of Rescue Medication Use	Week 6	0.00 days
Placebo	Duration of Rescue Medication Use	Week 1	1.00 days
Placebo	Duration of Rescue Medication Use	Week 11	0.00 days
Placebo	Duration of Rescue Medication Use	Week 7	0.00 days
Placebo	Duration of Rescue Medication Use	Week 15	0.00 days
Placebo	Duration of Rescue Medication Use	Week 10	0.00 days
Placebo	Duration of Rescue Medication Use	Week 9	0.00 days
Placebo	Duration of Rescue Medication Use	Week 3	0.00 days
Placebo	Duration of Rescue Medication Use	Week 16	0.00 days
Placebo	Duration of Rescue Medication Use	Week 14	0.00 days
Placebo	Duration of Rescue Medication Use	Week 4	0.00 days
Placebo	Duration of Rescue Medication Use	Week 8	0.00 days
Placebo	Duration of Rescue Medication Use	Week 13	0.00 days
Placebo	Duration of Rescue Medication Use	Week 5	0.00 days
Placebo	Duration of Rescue Medication Use	Week 2	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 4	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 8	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 1	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 2	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 3	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 5	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 6	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 7	0.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 9	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 10	0.50 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 11	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 12	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 13	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 14	1.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 15	0.00 days
Tanezumab 50 mcg/kg	Duration of Rescue Medication Use	Week 16	1.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 11	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 5	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 16	1.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 12	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 4	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 15	0.50 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 13	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 3	1.50 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 8	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 1	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 9	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 7	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 14	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 10	0.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 6	1.00 days
Tanezumab 200 mcg/kg	Duration of Rescue Medication Use	Week 2	0.00 days

Secondary

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Time frame: Baseline up to Week 16

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Discontinued the Study Due to Lack of Efficacy	8 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Discontinued the Study Due to Lack of Efficacy	5 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Discontinued the Study Due to Lack of Efficacy	6 Participants

Secondary

Number of Participants Who Used Rescue Medications

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Used Rescue Medications	Week 5	11 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 2	16 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 3	15 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 4	10 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 1	18 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 6	12 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 7	10 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 8	7 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 9	6 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 10	9 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 11	9 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 12	10 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 13	8 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 14	10 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 15	8 Participants
Placebo	Number of Participants Who Used Rescue Medications	Week 16	6 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 6	15 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 7	13 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 8	17 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 14	15 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 9	15 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 10	14 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 16	14 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 11	15 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 1	22 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 15	12 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 2	17 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 12	17 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 3	17 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 4	18 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 5	16 Participants
Tanezumab 50 mcg/kg	Number of Participants Who Used Rescue Medications	Week 13	15 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 11	11 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 6	15 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 13	9 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 3	17 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 7	13 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 16	13 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 1	12 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 8	11 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 12	11 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 5	10 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 9	12 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 14	8 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 2	14 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 10	13 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 4	13 Participants
Tanezumab 200 mcg/kg	Number of Participants Who Used Rescue Medications	Week 15	12 Participants

Secondary

Number of Participants With Abnormal Physical Examinations Findings at Screening

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)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Thyroid	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Neck	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Eyes	1 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Lungs	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Musculoskeletal	1 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	General	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Skin	10 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Heart	1 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Head	2 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Nose	1 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Ear	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Throat	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Abdomen	0 Participants
Placebo	Number of Participants With Abnormal Physical Examinations Findings at Screening	Extremities	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Neck	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Lungs	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Thyroid	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Abdomen	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Ear	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Extremities	5 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Eyes	4 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	General	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Head	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Heart	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Musculoskeletal	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Nose	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Skin	10 Participants
Tanezumab 50 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Throat	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Skin	10 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Musculoskeletal	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Extremities	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Ear	2 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Neck	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Abdomen	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Lungs	2 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Nose	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Thyroid	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Head	3 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	General	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Throat	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Heart	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Abnormal Physical Examinations Findings at Screening	Eyes	0 Participants

Secondary

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	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	Week 6: >=50% reduction	4 Participants
Placebo	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	Week 12: >=30% reduction	7 Participants
Placebo	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	Week 4: >=30% reduction	10 Participants
Placebo	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	Week 4: >=50% reduction	4 Participants
Placebo	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	Week 16: >=30% reduction	6 Participants
Placebo	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	Week 2: >=30% reduction	6 Participants
Placebo	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	Week 2: >=50% reduction	2 Participants
Placebo	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	Week 1: >=50% reduction	1 Participants
Placebo	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	Week 8: >=50% reduction	2 Participants
Placebo	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	Week 6: >=30% reduction	7 Participants
Placebo	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	Week 16: >=50% reduction	4 Participants
Placebo	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	Week 1: >=30% reduction	4 Participants
Placebo	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	Week 8: >=30% reduction	5 Participants
Placebo	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	Week 12: >=50% reduction	6 Participants
Tanezumab 50 mcg/kg	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	Week 6: >=50% reduction	3 Participants
Tanezumab 50 mcg/kg	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	Week 1: >=30% reduction	5 Participants
Tanezumab 50 mcg/kg	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	Week 2: >=30% reduction	4 Participants
Tanezumab 50 mcg/kg	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	Week 4: >=30% reduction	8 Participants
Tanezumab 50 mcg/kg	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	Week 6: >=30% reduction	7 Participants
Tanezumab 50 mcg/kg	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	Week 8: >=30% reduction	9 Participants
Tanezumab 50 mcg/kg	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	Week 12: >=30% reduction	10 Participants
Tanezumab 50 mcg/kg	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	Week 16: >=30% reduction	10 Participants
Tanezumab 50 mcg/kg	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	Week 1: >=50% reduction	3 Participants
Tanezumab 50 mcg/kg	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	Week 2: >=50% reduction	3 Participants
Tanezumab 50 mcg/kg	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	Week 4: >=50% reduction	2 Participants
Tanezumab 50 mcg/kg	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	Week 8: >=50% reduction	2 Participants
Tanezumab 50 mcg/kg	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	Week 12: >=50% reduction	6 Participants
Tanezumab 50 mcg/kg	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	Week 16: >=50% reduction	6 Participants
Tanezumab 200 mcg/kg	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	Week 12: >=50% reduction	7 Participants
Tanezumab 200 mcg/kg	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	Week 4: >=50% reduction	6 Participants
Tanezumab 200 mcg/kg	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	Week 8: >=30% reduction	13 Participants
Tanezumab 200 mcg/kg	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	Week 6: >=30% reduction	12 Participants
Tanezumab 200 mcg/kg	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	Week 6: >=50% reduction	8 Participants
Tanezumab 200 mcg/kg	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	Week 4: >=30% reduction	12 Participants
Tanezumab 200 mcg/kg	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	Week 1: >=30% reduction	5 Participants
Tanezumab 200 mcg/kg	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	Week 8: >=50% reduction	9 Participants
Tanezumab 200 mcg/kg	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	Week 2: >=30% reduction	6 Participants
Tanezumab 200 mcg/kg	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	Week 1: >=50% reduction	2 Participants
Tanezumab 200 mcg/kg	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	Week 16: >=30% reduction	9 Participants
Tanezumab 200 mcg/kg	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	Week 16: >=50% reduction	6 Participants
Tanezumab 200 mcg/kg	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	Week 2: >=50% reduction	2 Participants
Tanezumab 200 mcg/kg	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	Week 12: >=30% reduction	10 Participants

Secondary

Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at 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.

Time frame: Baseline, Week 6

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=30% reduction	14 Participants
Placebo	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=50% reduction	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=30% reduction	14 Participants
Tanezumab 50 mcg/kg	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=50% reduction	9 Participants
Tanezumab 200 mcg/kg	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=30% reduction	16 Participants
Tanezumab 200 mcg/kg	Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	>=50% reduction	13 Participants

Secondary

Number of Participants With Change From Baseline in Neurological Examination Findings at 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).

Time frame: Baseline, Week 16

Population: 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	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16	0 Participants

Secondary

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	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	Week 1: Change= 1	5 Participants
Placebo	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	Week 8: Change= 2	0 Participants
Placebo	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	Week 1: Change= 0	15 Participants
Placebo	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	Week 8: Change= 3	0 Participants
Placebo	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	Week 2: Change= 1	2 Participants
Placebo	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	Week 8: Change= 4	0 Participants
Placebo	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	Week 12: Change= -4	0 Participants
Placebo	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	Week 12: Change= -3	0 Participants
Placebo	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	Week 2: Change= 2	0 Participants
Placebo	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	Week 12: Change= -2	0 Participants
Placebo	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	Week 12: Change= -1	6 Participants
Placebo	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	Week 1: Change= --3	1 Participants
Placebo	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	Week 12: Change= 0	11 Participants
Placebo	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	Week 2: Change= 3	1 Participants
Placebo	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	Week 12: Change= 1	3 Participants
Placebo	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	Week 12: Change= 2	1 Participants
Placebo	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	Week 12: Change= 3	0 Participants
Placebo	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	Week 2: Change= 4	0 Participants
Placebo	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	Week 12: Change= 4	0 Participants
Placebo	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	Week 16: Change= -4	0 Participants
Placebo	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	Week 16: Change= -3	0 Participants
Placebo	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	Week 4: Change= --4	0 Participants
Placebo	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	Week 16: Change= -2	0 Participants
Placebo	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	Week 16: Change= 0	14 Participants
Placebo	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	Week 4: Change= --3	1 Participants
Placebo	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	Week 16: Change= 1	1 Participants
Placebo	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	Week 16: Change= 2	0 Participants
Placebo	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	Week 1: Change= 2	1 Participants
Placebo	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	Week 16: Change= 3	0 Participants
Placebo	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	Week 4: Change= --2	1 Participants
Placebo	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	Week 16: Change= 4	0 Participants
Placebo	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	Week 4: Change= --1	7 Participants
Placebo	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	Week 1: Change= --4	0 Participants
Placebo	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	Week 4: Change= 0	10 Participants
Placebo	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	Week 1: Change= 3	0 Participants
Placebo	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	Week 4: Change= 1	5 Participants
Placebo	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	Week 4: Change= 2	0 Participants
Placebo	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	Week 1: Change= --2	3 Participants
Placebo	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	Week 4: Change= 3	1 Participants
Placebo	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	Week 1: Change= 4	0 Participants
Placebo	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	Week 4: Change= 4	0 Participants
Placebo	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	Week 6: Change= --4	0 Participants
Placebo	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	Week 6: Change= --3	0 Participants
Placebo	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	Week 2: Change= --4	0 Participants
Placebo	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	Week 6: Change= --2	1 Participants
Placebo	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	Week 6: Change= --1	6 Participants
Placebo	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	Week 6: Change= 0	11 Participants
Placebo	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	Week 2: Change= --3	1 Participants
Placebo	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	Week 6: Change= 1	3 Participants
Placebo	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	Week 6: Change= 2	0 Participants
Placebo	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	Week 1: Change= --1	4 Participants
Placebo	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	Week 6: Change= 3	0 Participants
Placebo	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	Week 2: Change= --2	3 Participants
Placebo	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	Week 6: Change= 4	0 Participants
Placebo	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	Week 8: Change= --4	0 Participants
Placebo	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	Week 8: Change= --3	0 Participants
Placebo	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	Week 2: Change= --1	5 Participants
Placebo	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	Week 8: Change= --2	1 Participants
Placebo	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	Week 8: Change= -1	7 Participants
Placebo	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	Week 16: Change= -1	5 Participants
Placebo	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	Week 8: Change= 0	9 Participants
Placebo	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	Week 2: Change= 0	15 Participants
Placebo	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	Week 8: Change= 1	3 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= --2	1 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= 2	1 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= 2	1 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= --4	0 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= --1	5 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= --2	0 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= 0	17 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= 1	7 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= 0	20 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= -4	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= 0	19 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= --1	7 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= -3	0 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= --4	0 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= 1	1 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= -2	1 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= 2	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= -1	6 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= 1	0 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= 2	1 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= 0	12 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= --3	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= --1	4 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= 1	4 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= 2	1 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= 0	15 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= 2	2 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= 1	1 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 12: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= -4	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= 1	4 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= -1	7 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= -3	0 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= --4	0 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= --2	1 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= -2	1 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= --4	0 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= -1	5 Participants
Tanezumab 50 mcg/kg	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	Week 1: Change= --3	0 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= 0	15 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= --3	0 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= 0	17 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= 1	2 Participants
Tanezumab 50 mcg/kg	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	Week 4: Change= --3	0 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= --2	1 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= 2	1 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= --2	1 Participants
Tanezumab 50 mcg/kg	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	Week 2: Change= --4	0 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= 3	0 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 6: Change= --1	7 Participants
Tanezumab 50 mcg/kg	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	Week 16: Change= 4	0 Participants
Tanezumab 50 mcg/kg	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	Week 8: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= --4	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= --2	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= --1	8 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= 0	11 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= 1	7 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= 2	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 1: Change= 4	1 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= --4	0 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= --2	2 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= --1	2 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= 0	17 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= 1	3 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= 2	1 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 2: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= --4	0 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= --2	1 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= --1	8 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= 0	16 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= 1	2 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= 2	0 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 4: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= --4	0 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= --2	2 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= --1	6 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= 0	13 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= 1	2 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= 2	1 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 6: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= --4	0 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= --3	0 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= --2	2 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= -1	8 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= 0	12 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= 1	2 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= 2	1 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 8: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= -4	0 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= -3	1 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= -2	3 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= -1	5 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= 0	12 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= 1	3 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= 2	0 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= 3	0 Participants
Tanezumab 200 mcg/kg	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	Week 12: Change= 4	0 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= -4	0 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= -3	1 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= -2	1 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= -1	6 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= 0	10 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= 1	2 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= 2	0 Participants
Tanezumab 200 mcg/kg	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	Week 16: Change= 3	0 Participants

Secondary

Number of Participants With Change From Baseline in Physical Examinations Findings at 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.

Time frame: Baseline, Week 16

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16	3 Participants
Tanezumab 200 mcg/kg	Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16	1 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline in Vital Signs at 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.

Time frame: Baseline, Week 16

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16	0 Participants

Secondary

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Excellent	3 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Good	10 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Fair	9 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Poor	3 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Fair	4 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Good	8 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Good	11 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Poor	4 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Excellent	2 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Good	8 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Excellent	2 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Poor	7 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Excellent	0 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Good	5 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Fair	8 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Excellent	2 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Poor	11 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Good	9 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Fair	6 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Poor	7 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Fair	6 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Good	11 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Fair	7 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Poor	7 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Excellent	3 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Fair	5 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Excellent	2 Participants
Placebo	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Poor	7 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Excellent	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Excellent	4 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Excellent	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Poor	13 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Fair	5 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Good	9 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Poor	12 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Fair	4 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Good	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Excellent	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Poor	7 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Fair	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Good	10 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Excellent	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Poor	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Fair	9 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Good	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Excellent	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Poor	9 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Fair	9 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Good	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Excellent	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Poor	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Fair	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Good	7 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Poor	6 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Fair	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Good	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Fair	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Poor	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Excellent	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Good	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Excellent	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Poor	6 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Excellent	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Good	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Poor	13 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Poor	10 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Fair	9 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Excellent	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Fair	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 2: Poor	13 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Fair	6 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Good	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Fair	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Poor	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Good	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Good	7 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Excellent	2 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 16: Good	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 6: Excellent	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Good	6 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 12: Excellent	4 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 8: Poor	10 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 4: Fair	14 Participants
Tanezumab 200 mcg/kg	Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Week 1: Fair	8 Participants

Secondary

Number of Participants With Electrocardiogram (ECG) Abnormalities

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Electrocardiogram (ECG) Abnormalities	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Electrocardiogram (ECG) Abnormalities	0 Participants

Secondary

Number of Participants With Laboratory Abnormalities

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).

Time frame: Baseline up to Week 16

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Laboratory Abnormalities	22 Participants
Tanezumab 50 mcg/kg	Number of Participants With Laboratory Abnormalities	25 Participants
Tanezumab 200 mcg/kg	Number of Participants With Laboratory Abnormalities	20 Participants

Secondary

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	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 2	1 Participants
Placebo	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 8	2 Participants
Placebo	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 6	2 Participants
Placebo	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	0 Participants
Placebo	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 16	2 Participants
Placebo	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 12	3 Participants
Placebo	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 4	1 Participants
Tanezumab 50 mcg/kg	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 6	2 Participants
Tanezumab 50 mcg/kg	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 Participants
Tanezumab 50 mcg/kg	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 2	2 Participants
Tanezumab 50 mcg/kg	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 4	0 Participants
Tanezumab 50 mcg/kg	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 8	1 Participants
Tanezumab 50 mcg/kg	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 12	4 Participants
Tanezumab 50 mcg/kg	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 16	4 Participants
Tanezumab 200 mcg/kg	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 8	6 Participants
Tanezumab 200 mcg/kg	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 2	1 Participants
Tanezumab 200 mcg/kg	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 16	4 Participants
Tanezumab 200 mcg/kg	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 12	4 Participants
Tanezumab 200 mcg/kg	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 6	7 Participants
Tanezumab 200 mcg/kg	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 4	2 Participants
Tanezumab 200 mcg/kg	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	1 Participants

Secondary

Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at 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.

Time frame: Baseline, Week 6

Population: 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	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=70% reduction	1 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=40% reduction	5 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=90% reduction	0 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=60% reduction	3 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=50% reduction	4 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than 0% reduction	19 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=20% reduction	13 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than or equal to (>=)10% reduction	15 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=80% reduction	1 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=30% reduction	7 Participants
Placebo	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	100% reduction	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=50% reduction	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than 0% reduction	22 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than or equal to (>=)10% reduction	15 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=20% reduction	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=30% reduction	7 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=40% reduction	4 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=60% reduction	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=70% reduction	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=80% reduction	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=90% reduction	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	100% reduction	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=90% reduction	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=70% reduction	5 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=20% reduction	14 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than 0% reduction	19 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=80% reduction	2 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Greater than or equal to (>=)10% reduction	17 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=50% reduction	8 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=40% reduction	11 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	100% reduction	0 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=60% reduction	6 Participants
Tanezumab 200 mcg/kg	Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	>=30% reduction	12 Participants

Secondary

Number of Participants With Positive Anti-Drug Antibody (ADA) Response

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

Population: 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	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Response	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Positive Anti-Drug Antibody (ADA) Response	0 Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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)

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	20 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	24 Participants
Tanezumab 50 mcg/kg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	2 Participants
Tanezumab 200 mcg/kg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants
Tanezumab 200 mcg/kg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	21 Participants

Secondary

Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score

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

Population: 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	Measure	Group	Value (MEDIAN)
Placebo	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=30% Reduction	65.00 days
Placebo	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=50% Reduction	NA days
Tanezumab 50 mcg/kg	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=30% Reduction	NA days
Tanezumab 50 mcg/kg	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=50% Reduction	NA days
Tanezumab 200 mcg/kg	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=30% Reduction	57.00 days
Tanezumab 200 mcg/kg	Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to >=50% Reduction	NA days

Secondary

Time to Discontinuation Due to Lack of Efficacy

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

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

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Time to Discontinuation Due to Lack of Efficacy	71.32 days	Standard Error 4.95
Tanezumab 50 mcg/kg	Time to Discontinuation Due to Lack of Efficacy	40.79 days	Standard Error 1.82
Tanezumab 200 mcg/kg	Time to Discontinuation Due to Lack of Efficacy	72.13 days	Standard Error 3.91

Secondary

Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants

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

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

Arm	Measure	Group	Value (MEDIAN)	Dispersion
Placebo	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=30% reduction	8.00 days	Full Range 34.45
Placebo	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=50% reduction	0.00 days	Full Range 25.93
Tanezumab 50 mcg/kg	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=30% reduction	2.00 days	Full Range 35.44
Tanezumab 50 mcg/kg	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=50% reduction	0.00 days	Full Range 26.91
Tanezumab 200 mcg/kg	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=30% reduction	14.50 days	Full Range 38.55
Tanezumab 200 mcg/kg	Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration for >=50% reduction	2.50 days	Full Range 33.15

Other Pre-specified

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab

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

Population: 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	Measure	Value (MEAN)	Dispersion
Placebo	Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab	873666.5 ng*hr/mL	Standard Deviation 963283.79
Tanezumab 50 mcg/kg	Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab	2242378.0 ng*hr/mL	Standard Deviation 1128330.22

Other Pre-specified

Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose	C1	2101.8 nanogram per milliliter	Standard Deviation 1765.97
Placebo	Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose	C2688	101.810 nanogram per milliliter	Standard Deviation 325.241
Tanezumab 50 mcg/kg	Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose	C2688	170.984 nanogram per milliliter	Standard Deviation 241.639
Tanezumab 50 mcg/kg	Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose	C1	6861.6 nanogram per milliliter	Standard Deviation 4885.51

Other Pre-specified

Terminal Elimination Half-Life (t1/2) of Tanezumab

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

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Terminal Elimination Half-Life (t1/2) of Tanezumab	18.92 days	Standard Deviation 4.889
Tanezumab 50 mcg/kg	Terminal Elimination Half-Life (t1/2) of Tanezumab	22.76 days	Standard Deviation 7.336

Other Pre-specified

Total Clearance of Tanezumab From Plasma

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

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Total Clearance of Tanezumab From Plasma	0.082 milliliter per hour per kilogram	Standard Deviation 0.053
Tanezumab 50 mcg/kg	Total Clearance of Tanezumab From Plasma	0.093 milliliter per hour per kilogram	Standard Deviation 0.042

Other Pre-specified

Volume of Distribution at Steady State (Vss) for Tanezumab

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

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Volume of Distribution at Steady State (Vss) for Tanezumab	47.03 milliliter per kilogram	Standard Deviation 22.334
Tanezumab 50 mcg/kg	Volume of Distribution at Steady State (Vss) for Tanezumab	65.96 milliliter per kilogram	Standard Deviation 18.785

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

RN624 For Pain Of Post-Herpetic Neuralgia

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6

Amount of Rescue Medication Taken

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16

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

Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study

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

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

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

Duration of Rescue Medication Use

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Number of Participants Who Used Rescue Medications

Number of Participants With Abnormal Physical Examinations Findings at Screening

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

Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6

Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16

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

Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16

Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

Number of Participants With Electrocardiogram (ECG) Abnormalities

Number of Participants With Laboratory Abnormalities

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

Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6

Number of Participants With Positive Anti-Drug Antibody (ADA) Response

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score

Time to Discontinuation Due to Lack of Efficacy

Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab

Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose

Terminal Elimination Half-Life (t1/2) of Tanezumab

Total Clearance of Tanezumab From Plasma

Volume of Distribution at Steady State (Vss) for Tanezumab