Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Pain

Neoplastic Processes

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Tanezumab

Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.

Tanezumab 10 mg IV

IV Placebo for tanezumab

Pfizer CT.gov Call Center

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.

Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.

The worst pain was assessed an 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser pain intensity.

The worst pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The lower the value the lesser pain intensity.

BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to10 (Pain as bad as you can imagine), lower scores indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point NRS at 0 (Does not interfere) to 10 (Completely interferes).

BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower score indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).

BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores =lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).

BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores=lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).

Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity.

Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower scores indicate less pain intensity

The average daily opioid consumption was calculated as the daily sum of total opioid dosage in milligrams. Opioid consumption on each day was converted to the morphine equivalent dosage (MED). Results were summarized for opioid dose adjust period, baseline assessment period and post-baseline period.

Participants received immediate release (IR) opioid as rescue medication as needed for breakthrough pain from Day 1-113 at the dose determined during the pre-treatment phase, provided the average total daily dose of opioids between study visits does not exceed the baseline total daily opioid dose by more than 10%.

OR-SDS: participant-rated levels of frequency (F), severity (S), degree of bother (DoB) for 10 symptoms: fatigue, drowsiness, concentration, confusion, nausea, dizziness, constipation, itching, difficulty with urination, retching/vomiting. For each symptom levels of F, S and DoB scored as: frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'). Mean of F, S and DoB was calculated for each symptom to derive composite scores/multi-domain average (MDA) scores which ranges from 0 to 4.33. Higher MDA=worse symptom. Composite scores for frequency (FCS), severity (SCS), degree of bother, and MDA were calculated as mean of these scores across 10 symptoms and had same ranges as individual scores frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'); higher scores=more distress

Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual scores and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.

Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual items and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.

The Patient's Global Evaluation of Study Medication (PGESM) was a single item that assessed the participant's perception of his/her response to the study medication. It was a self-administered question that utilizes a 4-point Likert scale from 1="Poor" to 4="Excellent", where higher score represented better outcome.

The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized 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), where higher score represented more pain.

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

Physical examinations included general appearance (skin, neck, eyes, ears, nose, throat), cardiovascular system (including rhythm and presence of other cardiac abnormalities, such as gallops, murmurs, and cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system, and any additional assessments necessary to establish baseline status or evaluate symptoms or adverse experiences. Abnormalities in physical examination was based on investigator's discretion.

Neurological examinations assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index finger and great toes in order to complete the neuropathy impairment score (NIS). NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis) for muscle strength, higher score indicated higher abnormality/impairment, and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent) for sensation, higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.

Systolic BP: the measurement of the pressure when the heart is contracted (systole). The systolic pressure indicates the maximum amount of work/force the heart has to perform with each stroke in order to move blood through the arteries. Diastolic BP: the pressure in the large arteries during the relaxation of the left ventricle. The diastolic pressure indicates the amount of pressure the heart must overcome in order to generate the next beat.

Respiration rate measured as number of breaths taken per minute.

Heart rate is the number of heart beats per minute.

Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (\<0.8\*lower limit of normal \[LLN\]); red blood cell count (\<0.8\*LLN); platelets (\<0.5\*LLN or \>1.75\* upper limit of normal \[ULN\]); leucocytes (\<0.6\*LLN or \>1.5\*ULN); lymphocytes, total neutrophils (\<0.8\*LLN or \>1.2\*ULN); basophils, eosinophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (\>3\*ULN); creatinine, blood urea nitrogen (\>1.3\*ULN); glucose (\<0.6\*LLN or \>1.5\*ULN); uric acid (\>1.2\*ULN); sodium (\<0.95\*LLN or 1.05\*ULN); potassium, calcium, chloride, bicarbonate (\<0.9\*LLN or 1.1\*ULN); albumin, total protein (\<0.8\*LLN or 1.2\*ULN); urine analysis. Total number of participants without regards to baseline abnormality was summarized.

Human serum samples were analyzed using electrochemiluminescent (ECL) immunoassay for the presence of anti-tanezumab antibodies. Same participant may have positive (titer value \>=4.32) anti-tanezumab antibodies result at more than 1 time point.

ECG intervals included: RR (the time interval between consecutive heart beats), PR (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS (represented ventricular depolarization) and QT (time corresponding to the beginning of depolarization to repolarization of the ventricles), QTcF (QT interval corrected using Fridericia's formula \[FF\]), QTcB interval (QT interval corrected using Bazett's formula \[BF\]).

Standard 12-lead ECG performed after participant had rested quietly for at least 10 minutes in a supine position was measured. The time interval between consecutive heart beats \[RR interval\] (in beats per minute \[bpm\]) was used to calculate heart rate.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.

Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase.

Placebo

Total

Age, Customized

Sex: Female, Male

Intent-to-treat (ITT) population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo).

Pfizer ClinicalTrials.gov Call Center

Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.

Baseline

Change at Week 6

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using baseline observation carried forward (BOCF) method.

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

Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.

Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.

Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.

Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.

Change at Week 1

Change at Week 2

Change at Week 4

Change at Week 8

Change at Week 12

Change at Week 16

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. For time points after Week 8, inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

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

Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using LOCF method. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)

ITT population. Here "overall number of participants analyzed signifies those participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not performed because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF

ITT population. Here, overall number of participants analyzed=participants who were evaluable for this measure. number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF

ITT population. Missing values were imputed using BOCF method. Here overall number of participants analyzed signifies those participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not performed because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF

ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF

Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.

Week 1: >=30% reduction

Week 1: >=50% reduction

Week 1: >=70% reduction

Week 1: >=90% reduction

Week 2: >=30% reduction

Week 2: >=50% reduction

Week 2: >=70% reduction

Week 2: >=90% reduction

Week 4: >=30% reduction

Week 4: >=50% reduction

Week 4: >=70% reduction

Week 4: >=90% reduction

Week 6: >=30% reduction

Week 6: >=50% reduction

Week 6: >=70% reduction

Week 6: >=90% reduction

Week 8: >=30% reduction

Week 8: >=50% reduction

Week 8: >=70% reduction

Week 8: >=90% reduction

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. Data was not summarized statistically at week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF

Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using LOCF method. Data was not summarized statistically at week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF

Opioid Dose Adjust Period

Baseline Assessment Period

Post Baseline Period

ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). 'number analyzed'=participants evaluable at specific time period.

Average Daily Opioid Consumption

Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 9

Week 10

Week 11

Week 12

Week 13

Week 14

Week 15

Week 16

Number of Doses of Rescue Medication Required Per Week

Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.

Baseline Fatigue MDA

Change at Week 2 Fatigue MDA

Change at Week 4 Fatigue MDA

Change at Week 6 Fatigue MDA

Change at Week 12 Fatigue MDA

Change at Week 16 Fatigue MDA

Baseline Drowsiness MDA

Change at Week 2 Drowsiness MDA

Change at Week 4 Drowsiness MDA

Change at Week 6 Drowsiness MDA

Change at Week 12 Drowsiness MDA

ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points; "0" in number analyzed field signifies no participant was evaluable for the parameter at this time point. For time points after Week 6 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone	NCT00545129	Neoplasm Metast... Palliative Care	Tanezumab 10 mg... IV Placebo for ...	18 Years -	Pfizer
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone	NCT00545129	Neoplasm Metast... Palliative Care	Tanezumab 10 mg... IV Placebo for ...	18 Years -	Pfizer

Spots Global Cancer Trial Database for tanezumab 10 mg iv