The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Last observation carried forward (LOCF) method was used to impute missing values.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those who were evaluable for this measure.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The OMERACT-OARSI responder index is based on 3 parameters. OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score range: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score range: 0-10, higher score=higher pain/difficulty).

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported.

ITT population. LOCF method was used to impute missing values. Results for Week 1, 2, 4, 8 and 12 were not reported because analysis was not performed as per change in planned analysis.

Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants assessed average osteoarthritis pain in their knee in the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain. Baseline score was calculated as the mean of the scores over the 3 days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores within each study week.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' included those participants who were evaluable for this measure.

The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10, with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in movement of the knee.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

WOMAC: self-administered, disease-specific 24-item questionnaire, which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores. WOMAC pain, physical function and stiffness subscale and average score ranges from 0 to 10, where higher score indicates worse response.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

SF-36v2 is a standardized self-administered survey evaluating 8 aspects/domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning).

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

SF-36v2: standardized self-administered survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Median time to discontinuation due to lack of efficacy for participants who discontinued due to lack of efficacy was reported.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Incidence of rescue medication use is calculated as any use of rescue medication during the study week in question.

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Duration of rescue medication use is calculated as the number of study days per week when any rescue medication was taken.

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. The amount of rescue medication taken is the total dose (in mg) of acetaminophen rescue medication over the study week in question.

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

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 that were absent before treatment or that worsened relative to pretreatment state.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo).

Laboratory examination included blood chemistry, hematology and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The NIS constitutes the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) are scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score range 0-244 with higher score = more impairment.

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.

Data was not summarized separately and any clinically significant abnormality in physical finding was reported as an adverse event in this study.

Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration of subcutaneous injection or intravenous infusion.

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Serum samples were analyzed for determining total and free (unbound) NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method and free (unbound) NGF was analyzed using a validated, sensitive, and specific electrochemiluminescence (ECL) ligand binding assay.

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Number of participants were reported based on the maximum number of intravenous or subcutaneous doses of either tanezumab or placebo received.

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo).