An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.

Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Results are not reported for Tanezumab 5 mg group because all participants in this group had discontinued the study before Week 48.

Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

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).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.

Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.

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

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

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

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities).

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units 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 in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

Percentage of participants with at least 30%, 50%, 70% and 90% reduction from baseline in WOMAC pain subscale score are reported. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a 0 to 10 NRS, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 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. Participants with specified reduction (as percent) from baseline at Week 16 are reported.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

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

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

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 or hip. Each item was scored on a 0 to 10 NRS scale, where higher scores indicated higher pain/stiffness or worse function. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranged from 0 to 10, where higher score indicated worse response.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

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.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

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

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

United States Food and Drug Administration (FDA) approved analgesics were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.

ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group. Data were not collected beyond Week 48 due to premature termination of the study in response to FDA clinical hold.

United States FDA-approved analgesics were permitted as concomitant medications to relieve the pain of OA. These medications included opioids, topical analgesics, NSAIDs, capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.

ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group. Data were not collected beyond Week 48 due to premature termination of the study in response to FDA clinical hold.

Number of participants are reported based on the maximum number of subcutaneous doses of study medication received.

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.