Bone Metastasis, Cancer Pain
Conditions
Keywords
Metastatic cancer bone pain, Multiple myeloma
Brief summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase 3 study in cancer subjects requiring treatment with background opioids for pain due to bone metastasis. Approximately 144 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 72 subjects per group). Subjects will receive a total of 3 subcutaneous injections, separated by 8 weeks in addition to background opioids administered throughout the study. Treatment groups will include: 1. Placebo SC (matching tanezumab SC) in addition to background opioid therapy. 2. Tanezumab 20 mg SC in addition to background opioid therapy. The study consists of three periods: Pre-Treatment (up to 37 days), Double-Blind Treatment (24 weeks) and Safety Follow-up (24 weeks).
Interventions
DRUGTanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Sponsors
Eli Lilly and Company
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Personally signed and dated informed consent document. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Male or female, ≥18 years of age * Weight ≥40 kg at Screening * Cancer diagnosed as having metastasized to bone or multiple myeloma. * Imaging confirmation of bone metastasis at Screening or within 120 days prior to the Screening visit. * Expected to require daily opioid medication throughout the course of the study. * Willing to not use prohibited medications (including NSAIDs) throughout the duration of the study. * Average Pain Score ≥5 at Screening for the index bone metastasis cancer pain site. * Patient's Global Assessment of Cancer Pain of fair, poor or very poor at Screening. * Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at Screening. * Adequate bone marrow, renal and liver function at Screening. * International Normalized Ratio (INR) or prothrombin time (PT) \<1.5 x ULN at Screening unless being treated with anticoagulant medication. * Females must either be not of childbearing potential or, if of childbearing potential and at risk for pregnancy, must be willing to use at least one highly effective method of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous study medication.
Exclusion criteria
* Pain related to an oncologic emergency. * Brain metastasis or leptomeningeal metastasis. * Presence of hypercalcemia at Screening. * Pain primarily classified as not predominantly related to a bone metastasis. * Systemic treatment for the primary malignancy or bone metastasis started within 30 days of the Baseline Assessment Period. * Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during the study from 30 days prior to the first day of the Baseline Assessment Period to Week 48. * Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 30 days of the Baseline Assessment Period. * Concurrent adjuvant analgesics unless started at least 30 days prior to the start of the Baseline Assessment Period and maintained at a stable dose. * Diagnosis of osteoarthritis of the knee or hip or findings consistent with osteoarthritis in the shoulder. * History of significant trauma or surgery to a major joint within one year prior to Screening. * History of osteonecrosis or osteoporotic fracture. * X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture. * Signs and symptoms of clinically significant cardiac disease. * Evidence of orthostatic hypotension at Screening or at Baseline prior to randomization. * Diagnosis of a transient ischemic attack in the 6 months prior to Screening or diagnosis of stroke with significant residual deficits. * History, diagnosis, or signs and symptoms of clinically significant neurological disease. * Total impact score of \>7 on the Survey of Autonomic Symptoms (SAS) at Screening. * Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening. * History of significant alcohol, analgesic, or narcotic substance abuse within the six months prior to Screening. * Planned surgical procedure during the duration of the study. * Considered unfit for surgery or not willing to undergo joint replacement surgery if required. * Known hypersensitivity to opioids or an underlying medical condition contraindicating opioid use. * History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein. * Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody. * Presence of drugs of abuse, prescription medications without a valid prescription or other illegal drugs at Screening. * Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at Screening indicative of current infection. * Investigational site staff members and their family members, or Pfizer employees directly involved in the conduct of the trial. * Participation in other studies involving investigational drug(s) within 30 days (or 90 days for investigational biologics) before Baseline Assessment Period and/or during study participation. * Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use one (1) highly effective method of contraception throughout the study and for 112 days after last dose of investigational product. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | Baseline, Week 8 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. |
| Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly average pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week. |
| Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week. |
| Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the non-index visceral cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week. |
| Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week. |
| Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. |
| Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. |
| Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Baseline, Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, Considering all the ways your cancer pain affects you, how are you doing today? on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 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 scores signified worsening of condition. |
| Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Baseline, Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, Considering all the ways your cancer pain affects you, how are you doing today? on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: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 scores signified worsening of condition. |
| Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED). |
| Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported. |
| Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain) where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 12, 16 and 24 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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 were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose. |
| Number of Participants With Laboratory Abnormalities (Normal Baseline) | Baseline (Day 1, before dosing) up to Week 48 | Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes \< 0.8\*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio \>1.1\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, creatinine, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite \>=1. |
| Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | Baseline (Day 1, before dosing) up to Week 48 | Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes \< 0.8\* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes \<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; activated partial thromboplastin time, prothrombin time \>1.1\*ULN; bilirubin\>1.5\*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN. |
| Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Baseline (Day 1, before dosing) up to Week 24 | Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change \<=-40, change \>-40 to -30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30, change \>=30 to \<40 and change \>=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change \<=-30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30 and change \>=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below. |
| Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | Baseline (Day 1, before dosing) up to Week 24 | Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450\<=Value\<480 millisecond (msec), 480\<=Value\<500 msec and Value\>=500 msec. |
| Number of Participants With Confirmed Orthostatic Hypotension | Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48 | Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (\<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP \>=20 mmHg or reduction in diastolic BP \>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (\>) 150 mmHg (mean supine): reduction in systolic BP \>=30 mmHg or reduction in diastolic BP \>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. |
| Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | Day 1 of dosing up to maximum of Week 48 | The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure. |
| Number of Participants With Abnormal Physical Examination at Screening | Screening (up to 37 days prior to Day 1) | Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations. |
| Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | During the study, maximum up to Week 48 | Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome. |
| Number of Participants With At Least 1 Total Joint Replacements (TJR) | During the study, maximum up to Week 48 | Number of participants with joint replacement surgery were reported. |
| Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | Baseline (Day 1, before dosing) up to Week 48 | 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). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported. |
| Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Baseline, Weeks 2, 4, 8, 16, and 24 | OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, \>6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition. |
Countries
Argentina, Australia, Austria, Brazil, Chile, China, Czechia, Hungary, Israel, Japan, Poland, Romania, Slovakia, South Korea, Spain, United Kingdom
Participant flow
Recruitment details
Participants with cancer pain predominantly due to bone metastasis and receiving background opioid therapy, were randomized into 3 treatment arms: tanezumab 20 milligrams (mg), tanezumab 10 mg and placebo. After study start, tanezumab 10 mg arm was discontinued in protocol amendment 3: no new participants were enrolled into the arm. Existing participants in the arm received tanezumab 20 mg for any remaining doses and were included in tanezumab 10/20 mg arm.
Pre-assignment details
Total 325 participants signed the inform consent form (ICF). Out of which 158 participants were screen failures, and 11 participants were screened but not enrolled and randomized into the study. Total of 156 participants were enrolled and randomized into the study and assigned to study treatments.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks. | 73 |
| Tanezumab 10 mg Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. | 9 |
| Tanezumab 10/20 mg Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. | 1 |
| Tanezumab 20 mg Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. | 72 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 1 | 0 | 6 |
| Overall Study | Death | 15 | 1 | 1 | 19 |
| Overall Study | Insufficient clinical response | 2 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Other | 3 | 0 | 0 | 6 |
| Overall Study | Protocol Violation | 2 | 0 | 0 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 1 | 0 | 10 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 10 mg | Tanezumab 10/20 mg | Tanezumab 20 mg | Total |
|---|---|---|---|---|---|
| Age, Customized >=18 to <45 years | 10 Participants | 1 Participants | 0 Participants | 3 Participants | 14 Participants |
| Age, Customized >=45 to <65 years | 44 Participants | 4 Participants | 1 Participants | 33 Participants | 82 Participants |
| Age, Customized >=65 years | 19 Participants | 4 Participants | 0 Participants | 36 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 0 Participants | 0 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 9 Participants | 1 Participants | 67 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 3 Participants | 0 Participants | 16 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 6 Participants | 1 Participants | 55 Participants | 118 Participants |
| Sex: Female, Male Female | 39 Participants | 4 Participants | 0 Participants | 26 Participants | 69 Participants |
| Sex: Female, Male Male | 34 Participants | 5 Participants | 1 Participants | 46 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 73 | 1 / 9 | 1 / 1 | 21 / 72 |
| other Total, other adverse events | 43 / 73 | 8 / 9 | 1 / 1 | 49 / 72 |
| serious Total, serious adverse events | 52 / 73 | 9 / 9 | 1 / 1 | 62 / 72 |
Outcome results
Primary
Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.
Time frame: Baseline, Week 8
Population: The modified intent to treat (mITT) analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | -1.25 Units on a scale | Standard Error 0.35 |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | -2.03 Units on a scale | Standard Error 0.35 |
Comparison: Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.038195% CI: [-1.52, -0.04]ANCOVA
Secondary
Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED).
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | 189.62 mg of MED | Standard Deviation 333.77 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | 186.20 mg of MED | Standard Deviation 280.44 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | 177.87 mg of MED | Standard Deviation 266.93 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | 183.94 mg of MED | Standard Deviation 275.05 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | 189.78 mg of MED | Standard Deviation 353.1 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | 187.43 mg of MED | Standard Deviation 336.74 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | 188.10 mg of MED | Standard Deviation 281.01 |
| Placebo | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | 177.98 mg of MED | Standard Deviation 270.67 |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | NA mg of MED | — |
| Tanezumab 10 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | NA mg of MED | — |
| Tanezumab 10/20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | NA mg of MED | — |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | 173.48 mg of MED | Standard Deviation 329.17 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | 181.32 mg of MED | Standard Deviation 349.82 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | 173.45 mg of MED | Standard Deviation 346.27 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | 186.86 mg of MED | Standard Deviation 351.83 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | 177.06 mg of MED | Standard Deviation 332.39 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | 188.41 mg of MED | Standard Deviation 356.15 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | 170.31 mg of MED | Standard Deviation 327.19 |
| Tanezumab 20 mg | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | 346.95 mg of MED | Standard Deviation 1537 |
Secondary
Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | 0.86 Doses | Standard Deviation 0.93 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | 0.79 Doses | Standard Deviation 0.93 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | 1.08 Doses | Standard Deviation 0.69 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | 0.95 Doses | Standard Deviation 0.7 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | 1.15 Doses | Standard Deviation 0.76 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | 0.99 Doses | Standard Deviation 0.72 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | 0.92 Doses | Standard Deviation 0.94 |
| Placebo | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | 1.11 Doses | Standard Deviation 0.69 |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | NA Doses | — |
| Tanezumab 10 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | NA Doses | — |
| Tanezumab 10/20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | NA Doses | — |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24 | 0.69 Doses | Standard Deviation 0.57 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1 | 0.96 Doses | Standard Deviation 0.48 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2 | 0.89 Doses | Standard Deviation 0.52 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4 | 0.80 Doses | Standard Deviation 0.57 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6 | 0.80 Doses | Standard Deviation 0.65 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12 | 0.73 Doses | Standard Deviation 0.57 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16 | 0.75 Doses | Standard Deviation 0.57 |
| Tanezumab 20 mg | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8 | 0.81 Doses | Standard Deviation 0.61 |
Secondary
Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24
Participants at specified time points, answered to the following question, Considering all the ways your cancer pain affects you, how are you doing today? on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 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 scores signified worsening of condition.
Time frame: Baseline, Weeks 2, 4, 8, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 24 | -0.19 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 2 | -0.39 Units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 8 | -0.23 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 16 | -0.16 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 4 | -0.36 Units on a scale | Standard Error 0.14 |
| Tanezumab 10 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 16 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 24 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 24 | -0.29 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 16 | -0.32 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 4 | -0.66 Units on a scale | Standard Error 0.14 |
| Tanezumab 20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 8 | -0.56 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Change at Week 2 | -0.43 Units on a scale | Standard Error 0.12 |
Comparison: Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.p-value: 0.704595% CI: [-0.28, 0.19]ANCOVA
Comparison: Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.p-value: 0.040295% CI: [-0.59, -0.01]ANCOVA
Comparison: Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.p-value: 0.063795% CI: [-0.67, 0.02]ANCOVA
Comparison: Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.p-value: 0.380495% CI: [-0.53, 0.2]ANCOVA
Comparison: Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.p-value: 0.589495% CI: [-0.47, 0.27]ANCOVA
Secondary
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain) where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 12, 16 and 24 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 2 | -0.72 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 6 | -1.17 Units on a scale | Standard Error 0.33 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 1 | -0.40 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 4 | -1.03 Units on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 24 | -1.04 Units on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 16 | -1.37 Units on a scale | Standard Error 0.4 |
| Placebo | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 12 | -1.51 Units on a scale | Standard Error 0.37 |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 16 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 24 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 24 | -1.62 Units on a scale | Standard Error 0.43 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 6 | -2.04 Units on a scale | Standard Error 0.34 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 1 | -0.76 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 2 | -1.38 Units on a scale | Standard Error 0.23 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 4 | -1.77 Units on a scale | Standard Error 0.31 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 12 | -2.10 Units on a scale | Standard Error 0.37 |
| Tanezumab 20 mg | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Change at Week 16 | -1.92 Units on a scale | Standard Error 0.42 |
Comparison: Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.049795% CI: [-0.72, 0]ANCOVA
Comparison: Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.009295% CI: [-1.16, -0.17]ANCOVA
Comparison: Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.021895% CI: [-1.37, -0.11]ANCOVA
Comparison: Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.015495% CI: [-1.58, -0.17]ANCOVA
Comparison: Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.128995% CI: [-1.36, 0.17]ANCOVA
Comparison: Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.21195% CI: [-1.43, 0.32]ANCOVA
Comparison: Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.204995% CI: [-1.49, 0.32]ANCOVA
Secondary
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily average pain intensity in the non-index visceral cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed for this outcome measure.
Secondary
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -1.38 Units on a scale | Standard Error 0.36 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -1.14 Units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -0.74 Units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -1.20 Units on a scale | Standard Error 0.33 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -1.10 Units on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -1.32 Units on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -0.52 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -1.53 Units on a scale | Standard Error 0.36 |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -2.08 Units on a scale | Standard Error 0.34 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -1.90 Units on a scale | Standard Error 0.45 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -2.25 Units on a scale | Standard Error 0.38 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -1.47 Units on a scale | Standard Error 0.25 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -2.06 Units on a scale | Standard Error 0.43 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -0.84 Units on a scale | Standard Error 0.19 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -2.14 Units on a scale | Standard Error 0.37 |
| Tanezumab 20 mg | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -1.88 Units on a scale | Standard Error 0.31 |
Comparison: Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.110395% CI: [-0.73, 0.07]ANCOVA
Comparison: Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.008495% CI: [-1.26, -0.19]ANCOVA
Comparison: Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.023695% CI: [-1.39, -0.1]ANCOVA
Comparison: Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.015595% CI: [-1.59, -0.17]ANCOVA
Comparison: Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.050595% CI: [-1.52, 0]ANCOVA
Comparison: Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.076195% CI: [-1.52, 0.08]ANCOVA
Comparison: Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.126395% CI: [-1.7, 0.21]ANCOVA
Comparison: Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.105195% CI: [-1.76, 0.17]ANCOVA
Secondary
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed for this outcome measure.
Secondary
Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Weekly average pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -1.42 Units on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -1.64 Units on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -0.96 Units on a scale | Standard Error 0.54 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -1.79 Units on a scale | Standard Error 0.7 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -1.76 Units on a scale | Standard Error 0.65 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -0.87 Units on a scale | Standard Error 0.68 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -1.06 Units on a scale | Standard Error 0.71 |
| Placebo | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -0.64 Units on a scale | Standard Error 0.42 |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -1.92 Units on a scale | Standard Error 0.59 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -1.14 Units on a scale | Standard Error 0.35 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -1.81 Units on a scale | Standard Error 0.47 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -2.22 Units on a scale | Standard Error 0.52 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -2.24 Units on a scale | Standard Error 0.56 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -2.34 Units on a scale | Standard Error 0.62 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -2.14 Units on a scale | Standard Error 0.53 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -2.27 Units on a scale | Standard Error 0.6 |
Comparison: Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.300395% CI: [-1.47, 0.47]ANCOVA
Comparison: Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.160395% CI: [-2.03, 0.35]ANCOVA
Comparison: Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.229895% CI: [-2.13, 0.53]ANCOVA
Comparison: Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.505495% CI: [-1.93, 0.97]ANCOVA
Comparison: Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.479395% CI: [-2.1, 1.01]ANCOVA
Comparison: Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.449695% CI: [-1.83, 0.83]ANCOVA
Comparison: Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.126395% CI: [-2.77, 0.36]ANCOVA
Comparison: Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.p-value: 0.16295% CI: [-2.54, 0.44]ANCOVA
Secondary
Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24
OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, \>6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition.
Time frame: Baseline, Weeks 2, 4, 8, 16, and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: MDA Composite Score | 0.17 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Frequency Composite Score | 0.07 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: MDA Composite Score | -0.06 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Severity Composite Score | -0.10 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Severity Composite Score | -0.01 Units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Distress Composite Score | 0.12 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Frequency Composite Score | 0.29 Units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Severity Composite Score | -0.18 Units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Distress Composite Score | 0.33 Units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: MDA Composite Score | 0.02 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Distress Composite Score | 0.10 Units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Distress Composite Score | -0.08 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Frequency Composite Score | -0.06 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Severity Composite Score | -0.12 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Frequency Composite Score | 0.08 Units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: MDA Composite Score | -0.10 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: MDA Composite Score | 0.02 Units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Distress Composite Score | 0.03 Units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Severity Composite Score | -0.07 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Frequency Composite Score | -0.19 Units on a scale | Standard Error 0.14 |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Severity Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Distress Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: MDA Composite Score | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Frequency Composite Score | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Frequency Composite Score | -0.11 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: MDA Composite Score | -0.00 Units on a scale | Standard Error 0.13 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: MDA Composite Score | -0.02 Units on a scale | Standard Error 0.14 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Distress Composite Score | 0.09 Units on a scale | Standard Error 0.19 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Frequency Composite Score | -0.13 Units on a scale | Standard Error 0.24 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Frequency Composite Score | -0.07 Units on a scale | Standard Error 0.22 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Distress Composite Score | 0.11 Units on a scale | Standard Error 0.15 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Frequency Composite Score | -0.12 Units on a scale | Standard Error 0.14 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Severity Composite Score | 0.08 Units on a scale | Standard Error 0.17 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: Severity Composite Score | -0.02 Units on a scale | Standard Error 0.12 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Frequency Composite Score | -0.10 Units on a scale | Standard Error 0.16 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 2: MDA Composite Score | -0.02 Units on a scale | Standard Error 0.15 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: MDA Composite Score | 0.07 Units on a scale | Standard Error 0.2 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 4: Severity Composite Score | -0.01 Units on a scale | Standard Error 0.13 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Severity Composite Score | -0.17 Units on a scale | Standard Error 0.13 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: Distress Composite Score | -0.07 Units on a scale | Standard Error 0.24 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 16: MDA Composite Score | -0.04 Units on a scale | Standard Error 0.19 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Severity Composite Score | 0.16 Units on a scale | Standard Error 0.18 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 8: Distress Composite Score | 0.26 Units on a scale | Standard Error 0.2 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | Change at Week 24: Distress Composite Score | 0.22 Units on a scale | Standard Error 0.23 |
Comparison: Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.806995% CI: [-0.49, 0.38]Mixed Models Analysis
Comparison: Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.712795% CI: [-0.28, 0.41]Mixed Models Analysis
Comparison: Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.393395% CI: [-0.57, 0.23]Mixed Models Analysis
Comparison: Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.586995% CI: [-0.71, 0.41]Mixed Models Analysis
Comparison: Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.181495% CI: [-1.05, 0.21]Mixed Models Analysis
Comparison: Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.282295% CI: [-0.14, 0.46]Mixed Models Analysis
Comparison: Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.579595% CI: [-0.23, 0.41]Mixed Models Analysis
Comparison: Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.548695% CI: [-0.42, 0.22]Mixed Models Analysis
Comparison: Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.369295% CI: [-0.24, 0.63]Mixed Models Analysis
Comparison: Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.472495% CI: [-0.3, 0.63]Mixed Models Analysis
Comparison: Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.47795% CI: [-0.3, 0.64]Mixed Models Analysis
Comparison: Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.979195% CI: [-0.38, 0.37]Mixed Models Analysis
Comparison: Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.357495% CI: [-0.27, 0.74]Mixed Models Analysis
Comparison: Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.560795% CI: [-0.77, 0.42]Mixed Models Analysis
Comparison: Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.714395% CI: [-0.68, 0.47]Mixed Models Analysis
Comparison: Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.638195% CI: [-0.28, 0.45]Mixed Models Analysis
Comparison: Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.718195% CI: [-0.25, 0.37]Mixed Models Analysis
Comparison: Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.837895% CI: [-0.38, 0.31]Mixed Models Analysis
Comparison: Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.79595% CI: [-0.52, 0.4]Mixed Models Analysis
Comparison: Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.p-value: 0.671995% CI: [-0.62, 0.4]Mixed Models Analysis
Secondary
Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -1.18 Units on a scale | Standard Error 0.66 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -1.36 Units on a scale | Standard Error 0.68 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -0.34 Units on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -1.77 Units on a scale | Standard Error 0.74 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -1.62 Units on a scale | Standard Error 0.73 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -0.73 Units on a scale | Standard Error 0.79 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -0.85 Units on a scale | Standard Error 0.82 |
| Placebo | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -0.43 Units on a scale | Standard Error 0.5 |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | NA Units on a scale | — |
| Tanezumab 10/20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | NA Units on a scale | — |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 24 | -2.35 Units on a scale | Standard Error 0.67 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 1 | -1.50 Units on a scale | Standard Error 0.42 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 2 | -2.30 Units on a scale | Standard Error 0.51 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 4 | -2.62 Units on a scale | Standard Error 0.56 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 6 | -2.50 Units on a scale | Standard Error 0.61 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 8 | -2.54 Units on a scale | Standard Error 0.64 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 12 | -2.56 Units on a scale | Standard Error 0.57 |
| Tanezumab 20 mg | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Change at Week 16 | -2.75 Units on a scale | Standard Error 0.66 |
Comparison: Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.057595% CI: [-2.17, 0.04]ANCOVA
Comparison: Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.003195% CI: [-3.22, -0.7]ANCOVA
Comparison: Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.04195% CI: [-2.82, -0.06]ANCOVA
Comparison: Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.259895% CI: [-2.44, 0.68]ANCOVA
Comparison: Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.342695% CI: [-2.38, 0.85]ANCOVA
Comparison: Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.103495% CI: [-2.65, 0.26]ANCOVA
Comparison: Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.02995% CI: [-3.6, -0.21]ANCOVA
Comparison: Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.p-value: 0.0695% CI: [-3.31, 0.07]ANCOVA
Secondary
Number of Participants With Abnormal Physical Examination at Screening
Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations.
Time frame: Screening (up to 37 days prior to Day 1)
Population: The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Throat | 3 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | General | 3 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Abdomen | 2 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Extremities | 14 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Skin | 15 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Ears | 1 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Head | 2 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Other 2 | 1 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Nose | 0 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Neck | 2 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Other 1 | 9 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Thyroid | 2 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Other 3 | 0 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Lungs | 5 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Eyes | 4 Participants |
| Placebo | Number of Participants With Abnormal Physical Examination at Screening | Heart | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Throat | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Heart | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Eyes | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Nose | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Head | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Abdomen | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 3 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Skin | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 1 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Extremities | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 2 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Thyroid | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Neck | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Ears | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | General | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Physical Examination at Screening | Lungs | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Skin | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | General | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Head | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Eyes | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Ears | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Nose | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Neck | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Thyroid | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Lungs | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Heart | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Abdomen | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Extremities | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Abnormal Physical Examination at Screening | Throat | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Abdomen | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Heart | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Skin | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Lungs | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Thyroid | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 3 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Throat | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Neck | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Nose | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 1 | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Ears | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Eyes | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Other 2 | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Head | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | General | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Abnormal Physical Examination at Screening | Extremities | 10 Participants |
Secondary
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)
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). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported.
Time frame: Baseline (Day 1, before dosing) up to Week 48
Population: The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | ADA | 0 Participants |
| Placebo | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | NAb | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | NAb | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | ADA | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | ADA | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | NAb | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | ADA | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | NAb | 1 Participants |
Secondary
Number of Participants With At Least 1 Total Joint Replacements (TJR)
Number of participants with joint replacement surgery were reported.
Time frame: During the study, maximum up to Week 48
Population: The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With At Least 1 Total Joint Replacements (TJR) | 0 Participants |
| Tanezumab 10 mg | Number of Participants With At Least 1 Total Joint Replacements (TJR) | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With At Least 1 Total Joint Replacements (TJR) | 0 Participants |
| Tanezumab 20 mg | Number of Participants With At Least 1 Total Joint Replacements (TJR) | 1 Participants |
Secondary
Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change \<=-40, change \>-40 to -30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30, change \>=30 to \<40 and change \>=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change \<=-30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30 and change \>=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below.
Time frame: Baseline (Day 1, before dosing) up to Week 24
Population: The safety analysis set was defined as all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change <=-40 | 1 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-10 to 0 | 39 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=30 to <40 | 0 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-30 to -20 | 6 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-30 to -20 | 0 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-20 to -10 | 10 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-20 to -10 | 10 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-40 to -30 | 1 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=10 to <20 | 5 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-10 to 0 | 26 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >0 to <10 | 12 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >0 to <10 | 11 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=10 to <20 | 6 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=20 to <30 | 2 Participants |
| Placebo | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=20 to <30 | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=20 to <30 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-10 to 0 | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-10 to 0 | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=30 to <40 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-40 to -30 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-20 to -10 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >0 to <10 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-30 to -20 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-30 to -20 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=10 to <20 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=20 to <30 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=10 to <20 | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >0 to <10 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-20 to -10 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change <=-40 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=20 to <30 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change <=-40 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-40 to -30 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-30 to -20 | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-20 to -10 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-10 to 0 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >0 to <10 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=10 to <20 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=30 to <40 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-30 to -20 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-20 to -10 | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-10 to 0 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >0 to <10 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=10 to <20 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=20 to <30 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=10 to <20 | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-40 to -30 | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-10 to 0 | 26 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >0 to <10 | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-10 to 0 | 25 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change <=-40 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >0 to <10 | 18 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-20 to -10 | 14 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >-30 to -20 | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=20 to <30 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-30 to -20 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=30 to <40 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >=10 to <20 | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Diastolic Blood Pressure (mmHg) Change >-20 to -10 | 13 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Sitting Systolic Blood Pressure (mmHg) Change >=20 to <30 | 3 Participants |
Secondary
Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data
Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450\<=Value\<480 millisecond (msec), 480\<=Value\<500 msec and Value\>=500 msec.
Time frame: Baseline (Day 1, before dosing) up to Week 24
Population: The safety analysis set was analyzed. Here, Overall Number of Participants Analyzed signifies number of participants with post-baseline results evaluated against criteria. In reporting arm Tanezumab10/20 mg, the participant did not have post-baseline results evaluated against ECG (QTC) criteria, hence was not evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 480<=Value<500 | 0 Participants |
| Placebo | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 450<=Value<480 | 2 Participants |
| Placebo | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCF Interval 450<=Value<480 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 480<=Value<500 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 450<=Value<480 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCF Interval 450<=Value<480 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 450<=Value<480 | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCF Interval 450<=Value<480 | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | QTCB Interval 480<=Value<500 | 1 Participants |
Secondary
Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure.
Time frame: Day 1 of dosing up to maximum of Week 48
Population: The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | 2 Participants |
Secondary
Number of Participants With Confirmed Orthostatic Hypotension
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (\<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP \>=20 mmHg or reduction in diastolic BP \>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (\>) 150 mmHg (mean supine): reduction in systolic BP \>=30 mmHg or reduction in diastolic BP \>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Time frame: Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
Population: The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, number analyzed signifies participants evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
Secondary
Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set was analyzed. Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation Carried Forward (LOCF) imputation was applied. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 8 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 4 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 11 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 3 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 18 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 6 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 2 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 20 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 6 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 2 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 19 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 9 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 3 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 1 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 21 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 12 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 6 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 2 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 17 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 12 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 7 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 5 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 16 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 10 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 5 Participants |
| Placebo | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 21 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 16 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 27 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 19 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 30 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 19 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 19 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 28 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 18 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 32 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 25 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 27 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 18 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 13 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 2 Participants |
Comparison: Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.805495% CI: [0.41, 3.18]Regression, Logistic
Comparison: Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.929295% CI: [0.22, 3.98]Regression, Logistic
Comparison: Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9565Regression, Logistic
Comparison: Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.142995% CI: [0.81, 4.36]Regression, Logistic
Comparison: Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.01495% CI: [1.4, 19.31]Regression, Logistic
Comparison: Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.945Regression, Logistic
Comparison: Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9489Regression, Logistic
Comparison: Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.193295% CI: [0.78, 3.39]Regression, Logistic
Comparison: Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.025495% CI: [1.15, 8.74]Regression, Logistic
Comparison: Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.045595% CI: [1.03, 24.16]Regression, Logistic
Comparison: Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9464Regression, Logistic
Comparison: Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.096995% CI: [0.9, 3.72]Regression, Logistic
Comparison: Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.004395% CI: [1.58, 11.74]Regression, Logistic
Comparison: Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.035295% CI: [1.13, 26.75]Regression, Logistic
Comparison: Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9464Regression, Logistic
Comparison: Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.147195% CI: [0.83, 3.52]Regression, Logistic
Comparison: Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.040595% CI: [1.04, 6.22]Regression, Logistic
Comparison: Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.099395% CI: [0.8, 12.83]Regression, Logistic
Comparison: Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.172695% CI: [0.51, 43.64]Regression, Logistic
Comparison: Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.091895% CI: [0.91, 3.74]Regression, Logistic
Comparison: Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.070495% CI: [0.94, 4.82]Regression, Logistic
Comparison: Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.356995% CI: [0.56, 5.01]Regression, Logistic
Comparison: Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.306295% CI: [0.44, 13.79]Regression, Logistic
Comparison: Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.105895% CI: [0.88, 3.85]Regression, Logistic
Comparison: Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.157195% CI: [0.79, 4.14]Regression, Logistic
Comparison: Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.245495% CI: [0.65, 5.24]Regression, Logistic
Comparison: Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.886795% CI: [0.24, 3.46]Regression, Logistic
Comparison: Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.068995% CI: [0.95, 4.21]Regression, Logistic
Comparison: Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.056895% CI: [0.98, 5.44]Regression, Logistic
Comparison: Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.126895% CI: [0.78, 7.46]Regression, Logistic
Comparison: Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.797195% CI: [0.25, 6]Regression, Logistic
Secondary
Number of Participants With Individual Adjudicated Joint Safety Outcome/Event
Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome.
Time frame: During the study, maximum up to Week 48
Population: The safety analysis set was analyzed. Here, Overall Number of Participants Analyzed signifies participants who were analyzed by the Adjudication Committee. In reporting arm, Tanezumab10/20 mg the participant did not have potential joint related safety event for analysis by Adjudication Committee.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 2 | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Subchondral Insufficiency Fracture | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Primary Osteonecrosis | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Other Joint Outcome | 1 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 1 | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Pathological Fracture | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Normal Progression of OA | 0 Participants |
| Placebo | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 1 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Normal Progression of OA | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Other Joint Outcome | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 2 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Primary Osteonecrosis | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Pathological Fracture | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Subchondral Insufficiency Fracture | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Other Joint Outcome | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 1 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Rapidly Progressive OA type 2 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Primary Osteonecrosis | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Pathological Fracture | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Subchondral Insufficiency Fracture | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Normal Progression of OA | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes \< 0.8\* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes \<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; activated partial thromboplastin time, prothrombin time \>1.1\*ULN; bilirubin\>1.5\*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; creatine kinase \>2.0\*ULN.
Time frame: Baseline (Day 1, before dosing) up to Week 48
Population: The safety analysis set was analyzed. Here, Overall Number of Participants Analyzed signifies participants with an abnormal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm Tanezumab10/20 mg, who met the criteria for data collection and analysis of this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | 15 Participants |
| Tanezumab 10 mg | Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | 14 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Normal Baseline)
Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes \< 0.8\*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*upper limit of normal (ULN); platelets \<0.5\*LLN,\>1.75\* ULN; leukocytes\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN, \>1.2\*ULN; basophils, eosinophils, monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio \>1.1\*ULN; bilirubin \>1.5\*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein; albumin\<0.8\*LLN, \>1.2\*ULN; urea nitrogen, creatinine, cholesterol, triglycerides \>1.3\*ULN; urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite \>=1.
Time frame: Baseline (Day 1, before dosing) up to Week 48
Population: The safety analysis set was analyzed. Here, Overall Number of Participants Analyzed signifies participants with a normal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm Tanezumab10/20 mg, who met the criteria for data collection and analysis of this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Abnormalities (Normal Baseline) | 18 Participants |
| Tanezumab 10 mg | Number of Participants With Laboratory Abnormalities (Normal Baseline) | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Laboratory Abnormalities (Normal Baseline) | 20 Participants |
Secondary
Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
Participants at specified time points, answered to the following question, Considering all the ways your cancer pain affects you, how are you doing today? on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: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 scores signified worsening of condition.
Time frame: Baseline, Weeks 2, 4, 8, 16 and 24
Population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. Here, ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 24 | 9 Participants |
| Placebo | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 2 | 7 Participants |
| Placebo | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 8 | 10 Participants |
| Placebo | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 16 | 9 Participants |
| Placebo | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 4 | 9 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 8 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 2 | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 4 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 16 | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 24 | 1 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 8 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 2 | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 4 | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 24 | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 16 | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 4 | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 8 | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Week 2 | 5 Participants |
Comparison: Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.203395% CI: [0.09, 1.69]Regression, Logistic
Comparison: Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.762795% CI: [0.41, 3.41]Regression, Logistic
Comparison: Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.689495% CI: [0.44, 3.43]Regression, Logistic
Comparison: Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.590595% CI: [0.47, 3.83]Regression, Logistic
Comparison: Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.835495% CI: [0.38, 3.35]Regression, Logistic
Secondary
Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Population: The mITT analysis set was analyzed. Multiple imputation method was applied. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 11 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 9 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 7 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 5 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 16 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 8 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 9 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 7 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 11 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 12 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 5 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 3 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 7 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 13 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 4 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 9 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 2 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 1 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 4 Participants |
| Placebo | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 14 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 0 Participants |
| Tanezumab 10/20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=90% | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=70% | 8 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=30% | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=70% | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=50% | 16 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 8: Reduction of >=30% | 24 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=90% | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=90% | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=90% | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=70% | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=30% | 24 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=50% | 14 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 6: Reduction of >=30% | 26 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=50% | 18 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=90% | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=70% | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=70% | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=50% | 14 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 4: Reduction of >=30% | 21 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 16: Reduction of >=90% | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=90% | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=70% | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=30% | 25 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=50% | 8 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 2: Reduction of >=30% | 17 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=50% | 18 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=90% | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=70% | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 24: Reduction of >=70% | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=30% | 24 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 1: Reduction of >=50% | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Week 12: Reduction of >=50% | 16 Participants |
Comparison: Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.665895% CI: [0.43, 3.7]Regression, Logistic
Comparison: Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.344395% CI: [0.3, 31.35]Regression, Logistic
Comparison: Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9527Regression, Logistic
Comparison: Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.075795% CI: [0.92, 5.5]Regression, Logistic
Comparison: Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.065995% CI: [0.91, 22.42]Regression, Logistic
Comparison: Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.938Regression, Logistic
Comparison: Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9493Regression, Logistic
Comparison: Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.091495% CI: [0.89, 4.59]Regression, Logistic
Comparison: Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.035995% CI: [1.08, 9.61]Regression, Logistic
Comparison: Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9538Regression, Logistic
Comparison: Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9493Regression, Logistic
Comparison: Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.014395% CI: [1.22, 5.8]Regression, Logistic
Comparison: Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.017695% CI: [1.28, 13.74]Regression, Logistic
Comparison: Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.129895% CI: [0.69, 18.06]Regression, Logistic
Comparison: Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.9493Regression, Logistic
Comparison: Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.052795% CI: [0.99, 4.67]Regression, Logistic
Comparison: Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.045795% CI: [1.02, 7.12]Regression, Logistic
Comparison: Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.099495% CI: [0.77, 19.76]Regression, Logistic
Comparison: Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.697795% CI: [0.07, 5.86]Regression, Logistic
Comparison: Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.14695% CI: [0.82, 3.75]Regression, Logistic
Comparison: Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.074295% CI: [0.92, 6.01]Regression, Logistic
Comparison: Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.556595% CI: [0.42, 4.91]Regression, Logistic
Comparison: Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.562395% CI: [0.28, 10.35]Regression, Logistic
Comparison: Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.011695% CI: [1.27, 6.47]Regression, Logistic
Comparison: Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.061595% CI: [0.96, 5.7]Regression, Logistic
Comparison: Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.331695% CI: [0.59, 4.8]Regression, Logistic
Comparison: Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.994695% CI: [0.19, 5.33]Regression, Logistic
Comparison: Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.008395% CI: [1.33, 6.76]Regression, Logistic
Comparison: Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.051395% CI: [1, 5.88]Regression, Logistic
Comparison: Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.152895% CI: [0.71, 8.58]Regression, Logistic
Comparison: Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).p-value: 0.725195% CI: [0.21, 9.65]Regression, Logistic
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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 were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose.
Time frame: Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Population: The safety analysis set was defined as all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 52 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 9 Participants |
| Tanezumab 10/20 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 62 Participants |