Neoplasm Metastasis, Palliative Care
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.
Interventions
Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
DRUGIV Placebo for tanezumab
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Sponsors
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
* Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain. * Requires daily opioid medication
Exclusion criteria
* Patients who do not have bone pain caused by cancer are not eligible for the study. * Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible. * Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening. * Known history of rheumatoid arthritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 | Baseline, Week 6 | Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser the pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | The worst pain was assessed an 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser pain intensity. |
| Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | The worst pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the lesser pain intensity. |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to10 (Pain as bad as you can imagine), lower scores indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point NRS at 0 (Does not interfere) to 10 (Completely interferes). |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower score indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes). |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores =lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes). |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores=lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes). |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1, 2, 4, 6, 8, 12, 16 | Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower scores indicate less pain intensity. |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1, 2, 4, 6, 8, 12, 16 | Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower scores indicate less pain intensity |
| Average Daily Opioid Consumption | Opioid Dose Adjust Period (Day-30 to Day-4), Baseline Assessment period (Day-3 to Day-1), Post Baseline Period (Day 1 to Week 16) | The average daily opioid consumption was calculated as the daily sum of total opioid dosage in milligrams. Opioid consumption on each day was converted to the morphine equivalent dosage (MED). Results were summarized for opioid dose adjust period, baseline assessment period and post-baseline period. |
| Number of Doses of Rescue Medication Required Per Week | Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 | Participants received immediate release (IR) opioid as rescue medication as needed for breakthrough pain from Day 1-113 at the dose determined during the pre-treatment phase, provided the average total daily dose of opioids between study visits does not exceed the baseline total daily opioid dose by more than 10%. |
| Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline, Week 2, 4, 6, 12, 16 | OR-SDS: participant-rated levels of frequency (F), severity (S), degree of bother (DoB) for 10 symptoms: fatigue, drowsiness, concentration, confusion, nausea, dizziness, constipation, itching, difficulty with urination, retching/vomiting. For each symptom levels of F, S and DoB scored as: frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'). Mean of F, S and DoB was calculated for each symptom to derive composite scores/multi-domain average (MDA) scores which ranges from 0 to 4.33. Higher MDA=worse symptom. Composite scores for frequency (FCS), severity (SCS), degree of bother, and MDA were calculated as mean of these scores across 10 symptoms and had same ranges as individual scores frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'); higher scores=more distress |
| Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual scores and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference. |
| Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual items and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference. |
| Patient's Global Evaluation of Study Medication | Week 1, 2, 4, 6, 8, 12, 16 | The Patient's Global Evaluation of Study Medication (PGESM) was a single item that assessed the participant's perception of his/her response to the study medication. It was a self-administered question that utilizes a 4-point Likert scale from 1=Poor to 4=Excellent, where higher score represented better outcome. |
| Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain. |
| Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Baseline, Weeks 1, 2, 4, 8, 12, 16 | Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser pain intensity. |
| Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 1, 2, 4, 6, 8, 12, 16 | The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain. |
| Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 1, 2, 4, 6, 8, 12, 16 | The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 113 days | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 113 days that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Physical Examination Abnormalities | Baseline up to Week 16 or Early Termination (up to 113 days) | Physical examinations included general appearance (skin, neck, eyes, ears, nose, throat), cardiovascular system (including rhythm and presence of other cardiac abnormalities, such as gallops, murmurs, and cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system, and any additional assessments necessary to establish baseline status or evaluate symptoms or adverse experiences. Abnormalities in physical examination was based on investigator's discretion. |
| Number of Participants With Abnormal Neurological Examination | Week 2, 4, 6, 12, 16, Early Termination (up to 113 days) | Neurological examinations assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index finger and great toes in order to complete the neuropathy impairment score (NIS). NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis) for muscle strength, higher score indicated higher abnormality/impairment, and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent) for sensation, higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. |
| Vital Sign Examination: Body Temperature | Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days) | — |
| Vital Sign Examination: Blood Pressure (BP) | Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days) | Systolic BP: the measurement of the pressure when the heart is contracted (systole). The systolic pressure indicates the maximum amount of work/force the heart has to perform with each stroke in order to move blood through the arteries. Diastolic BP: the pressure in the large arteries during the relaxation of the left ventricle. The diastolic pressure indicates the amount of pressure the heart must overcome in order to generate the next beat. |
| Vital Sign Examination: Respiratory Rate | Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days) | Respiration rate measured as number of breaths taken per minute. |
| Vital Sign Examination: Heart Rate | Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, and Early Termination (up to 113 days) | Heart rate is the number of heart beats per minute. |
| Body Weight of Participants | Baseline, Week 6, 16 and Early Termination (up to 113 days) | — |
| Number of Participants With Abnormal Laboratory Examination | Baseline up to Week 16, Early Termination (up to 113 days) | Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (\<0.8\*lower limit of normal \[LLN\]); red blood cell count (\<0.8\*LLN); platelets (\<0.5\*LLN or \>1.75\* upper limit of normal \[ULN\]); leucocytes (\<0.6\*LLN or \>1.5\*ULN); lymphocytes, total neutrophils (\<0.8\*LLN or \>1.2\*ULN); basophils, eosinophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (\>3\*ULN); creatinine, blood urea nitrogen (\>1.3\*ULN); glucose (\<0.6\*LLN or \>1.5\*ULN); uric acid (\>1.2\*ULN); sodium (\<0.95\*LLN or 1.05\*ULN); potassium, calcium, chloride, bicarbonate (\<0.9\*LLN or 1.1\*ULN); albumin, total protein (\<0.8\*LLN or 1.2\*ULN); urine analysis. Total number of participants without regards to baseline abnormality was summarized. |
| Number of Participants With Anti-drug Antibodies | Baseline (Day 1), Week 4, 6, 12, 16 | Human serum samples were analyzed using electrochemiluminescent (ECL) immunoassay for the presence of anti-tanezumab antibodies. Same participant may have positive (titer value \>=4.32) anti-tanezumab antibodies result at more than 1 time point. |
| Electrocardiogram Examination | Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days) | ECG intervals included: RR (the time interval between consecutive heart beats), PR (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS (represented ventricular depolarization) and QT (time corresponding to the beginning of depolarization to repolarization of the ventricles), QTcF (QT interval corrected using Fridericia's formula \[FF\]), QTcB interval (QT interval corrected using Bazett's formula \[BF\]). |
| Electrocardiogram Examination: Heart Rate | Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days) | Standard 12-lead ECG performed after participant had rested quietly for at least 10 minutes in a supine position was measured. The time interval between consecutive heart beats \[RR interval\] (in beats per minute \[bpm\]) was used to calculate heart rate. |
| Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain. |
Countries
Austria, Bosnia and Herzegovina, Croatia, France, Hungary, India, Latvia, Mexico, Peru, Poland, Slovakia, South Korea, United States
Participant flow
Pre-assignment details
Post Week 8 visit, participants were eligible to rollover to extension study A4091029 (NCT00830180).
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab Single intravenous infusion of tanezumab 10 mg over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase. | 29 |
| Placebo Single intravenous infusion of placebo matched to tanezumab over 5 minutes on Day 1, along with background opioid medication administered daily for 113 days. Total daily dose of opioid medication was determined as per accepted clinical guidelines in the opioid adjustment period during pre-treatment phase. | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 2 | 1 |
| Overall Study | Lack of Efficacy | 2 | 5 |
| Overall Study | Other | 3 | 3 |
| Overall Study | Rollover to Study A4091029 (NCT00830180) | 9 | 14 |
Baseline characteristics
| Characteristic | Tanezumab | Total | Placebo |
|---|---|---|---|
| Age, Customized 18 to 44 years | 1 Participants | 7 Participants | 6 Participants |
| Age, Customized 45 to 64 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 13 Participants | 22 Participants | 9 Participants |
| Age, Customized Less than (<) 18 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 29 | 16 / 30 |
| serious Total, serious adverse events | 7 / 29 | 4 / 30 |
Outcome results
Primary
Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser the pain intensity.
Time frame: Baseline, Week 6
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using baseline observation carried forward (BOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 | Baseline | 5.4 units on a scale | Standard Deviation 1.02 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 | Change at Week 6 | -1.3 units on a scale | Standard Deviation 1.81 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 | Baseline | 5.3 units on a scale | Standard Deviation 0.98 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6 | Change at Week 6 | -0.9 units on a scale | Standard Deviation 1.52 |
Comparison: Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.p-value: 0.56995% CI: [-1.18, 0.66]ANCOVA
Secondary
Average Daily Opioid Consumption
The average daily opioid consumption was calculated as the daily sum of total opioid dosage in milligrams. Opioid consumption on each day was converted to the morphine equivalent dosage (MED). Results were summarized for opioid dose adjust period, baseline assessment period and post-baseline period.
Time frame: Opioid Dose Adjust Period (Day-30 to Day-4), Baseline Assessment period (Day-3 to Day-1), Post Baseline Period (Day 1 to Week 16)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). 'number analyzed'=participants evaluable at specific time period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Average Daily Opioid Consumption | Opioid Dose Adjust Period | 112.8 MED | Standard Deviation 123.22 |
| Tanezumab | Average Daily Opioid Consumption | Baseline Assessment Period | 111.8 MED | Standard Deviation 134.59 |
| Tanezumab | Average Daily Opioid Consumption | Post Baseline Period | 111.9 MED | Standard Deviation 137.22 |
| Placebo | Average Daily Opioid Consumption | Opioid Dose Adjust Period | 98.3 MED | Standard Deviation 107.42 |
| Placebo | Average Daily Opioid Consumption | Baseline Assessment Period | 102.0 MED | Standard Deviation 112.78 |
| Placebo | Average Daily Opioid Consumption | Post Baseline Period | 102.7 MED | Standard Deviation 111.83 |
Secondary
Body Weight of Participants
Time frame: Baseline, Week 6, 16 and Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies participants who were evaluable for this measure. Number analyzed=participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Body Weight of Participants | Baseline | 68.5 Kilogram (Kg) | Standard Deviation 11.98 |
| Tanezumab | Body Weight of Participants | Week 6 | 67.4 Kilogram (Kg) | Standard Deviation 13.03 |
| Tanezumab | Body Weight of Participants | Week 16 | 66.5 Kilogram (Kg) | Standard Deviation 10.91 |
| Tanezumab | Body Weight of Participants | Early Termination | 64.6 Kilogram (Kg) | Standard Deviation 12.12 |
| Placebo | Body Weight of Participants | Early Termination | 73.1 Kilogram (Kg) | Standard Deviation 18.02 |
| Placebo | Body Weight of Participants | Baseline | 72.6 Kilogram (Kg) | Standard Deviation 17.35 |
| Placebo | Body Weight of Participants | Week 16 | 76.0 Kilogram (Kg) | Standard Deviation 14.6 |
| Placebo | Body Weight of Participants | Week 6 | 74.3 Kilogram (Kg) | Standard Deviation 17.67 |
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual items and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline General Activity | 5.41 units on a scale | Standard Deviation 1.34 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Composite Score | -0.4 units on a scale | Standard Deviation 1.73 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Composite Score | -1.0 units on a scale | Standard Deviation 1.47 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Composite Score | -1.4 units on a scale | Standard Deviation 1.57 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Composite Score | -1.3 units on a scale | Standard Deviation 1.64 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Composite Score | -1.3 units on a scale | Standard Deviation 1.96 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Composite Score | -1.3 units on a scale | Standard Deviation 2.1 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Composite Score | -1.3 units on a scale | Standard Deviation 2.11 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Composite Score | 4.90 units on a scale | Standard Deviation 1.56 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 General Activity | -0.7 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 General Activity | -1.1 units on a scale | Standard Deviation 1.91 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 General Activity | -1.5 units on a scale | Standard Deviation 2.08 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 General Activity | -1.4 units on a scale | Standard Deviation 2.08 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 General Activity | -1.4 units on a scale | Standard Deviation 2.31 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 General Activity | -1.2 units on a scale | Standard Deviation 2.55 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 General Activity | -1.4 units on a scale | Standard Deviation 2.47 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Walking Ability | 4.4 units on a scale | Standard Deviation 2.32 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Walking Ability | -0.1 units on a scale | Standard Deviation 2.33 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Walking Ability | -0.2 units on a scale | Standard Deviation 2.33 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Walking Ability | -0.8 units on a scale | Standard Deviation 1.98 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Walking Ability | -0.6 units on a scale | Standard Deviation 2.31 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Walking Ability | -0.8 units on a scale | Standard Deviation 2.66 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Walking Ability | -0.5 units on a scale | Standard Deviation 2.69 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Walking Ability | -0.5 units on a scale | Standard Deviation 2.76 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Normal Work | 5.19 units on a scale | Standard Deviation 1.92 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Normal Work | -0.50 units on a scale | Standard Deviation 2.76 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Normal Work | -1.04 units on a scale | Standard Deviation 2.12 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Normal Work | -1.24 units on a scale | Standard Deviation 2.15 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Normal Work | -1.04 units on a scale | Standard Deviation 2.62 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Normal Work | -1.08 units on a scale | Standard Deviation 2.53 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Normal Work | -1.36 units on a scale | Standard Deviation 2.41 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Normal Work | -1.52 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Normal Work | -0.68 units on a scale | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Composite Score | 5.19 units on a scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Walking Ability | 5.5 units on a scale | Standard Deviation 2.04 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Composite Score | -0.9 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline Normal Work | 5.69 units on a scale | Standard Deviation 2.26 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Composite Score | -1.5 units on a scale | Standard Deviation 2.42 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Walking Ability | -0.8 units on a scale | Standard Deviation 2.94 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Composite Score | -1.2 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Normal Work | -0.72 units on a scale | Standard Deviation 2.91 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Composite Score | -1.0 units on a scale | Standard Deviation 2.13 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Walking Ability | -1.0 units on a scale | Standard Deviation 2.89 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Composite Score | -0.8 units on a scale | Standard Deviation 2.13 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 Normal Work | -0.52 units on a scale | Standard Deviation 3.08 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Composite Score | -0.9 units on a scale | Standard Deviation 1.94 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Walking Ability | -0.9 units on a scale | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Composite Score | -0.9 units on a scale | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Normal Work | -0.64 units on a scale | Standard Deviation 2.45 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline General Activity | 5.41 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 Walking Ability | -1.0 units on a scale | Standard Deviation 2.52 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 General Activity | -1.0 units on a scale | Standard Deviation 2.29 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 Normal Work | -1.00 units on a scale | Standard Deviation 3.46 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 General Activity | -1.2 units on a scale | Standard Deviation 2.73 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Walking Ability | -0.5 units on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 General Activity | -1.0 units on a scale | Standard Deviation 2.46 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 Normal Work | -0.84 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 General Activity | -0.8 units on a scale | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 Walking Ability | -0.4 units on a scale | Standard Deviation 2.31 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 General Activity | -0.5 units on a scale | Standard Deviation 2.87 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 Normal Work | -1.16 units on a scale | Standard Deviation 2.69 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 General Activity | -0.6 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 Walking Ability | -0.4 units on a scale | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 General Activity | -0.7 units on a scale | Standard Deviation 2.76 |
Comparison: Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.89795% CI: [-1.34, 1.19]ANCOVA
Comparison: Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.64395% CI: [-0.9, 1.43]ANCOVA
Comparison: Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.46495% CI: [-1.45, 0.68]ANCOVA
Comparison: Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.59395% CI: [-1.46, 0.86]ANCOVA
Comparison: Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.42395% CI: [-1.77, 0.77]ANCOVA
Comparison: Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.80595% CI: [-1.21, 1.54]ANCOVA
Comparison: Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.88295% CI: [-1.3, 1.51]ANCOVA
Comparison: Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.44695% CI: [-1.79, 0.81]ANCOVA
Comparison: Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.60495% CI: [-1.77, 1.05]ANCOVA
Comparison: Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.39395% CI: [-2.24, 0.91]ANCOVA
Comparison: Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.39995% CI: [-2.33, 0.97]ANCOVA
Comparison: Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.87695% CI: [-1.43, 1.66]ANCOVA
Comparison: Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.7495% CI: [-1.58, 1.14]ANCOVA
Comparison: Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.85495% CI: [-1.56, 1.31]ANCOVA
Comparison: Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.43695% CI: [-2.24, 1]ANCOVA
Comparison: Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.08795% CI: [-2.81, 0.21]ANCOVA
Comparison: Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.27895% CI: [-2.4, 0.72]ANCOVA
Comparison: Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.54895% CI: [-1.84, 1]ANCOVA
Comparison: Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.31895% CI: [-2.33, 0.79]ANCOVA
Comparison: Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.48495% CI: [-2.02, 0.99]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
Participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) assessed interference of pain in functional activities (general activity, walking ability, and normal work) in past 24 hours. Measures were scored by individual item as well as function composite score (calculated by taking mean of individual interference scores), both (individual scores and composite scores) ranging from 0 to 10 with lower scores being indicative of less pain interference.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Here overall number of participants analyzed signifies those participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not performed because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline General Activity | 5.41 units on a scale | Standard Deviation 1.34 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Composite Score | -0.3 units on a scale | Standard Deviation 1.49 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Composite Score | -0.9 units on a scale | Standard Deviation 1.41 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Composite Score | -1.3 units on a scale | Standard Deviation 1.56 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Composite Score | -1.1 units on a scale | Standard Deviation 1.53 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Composite Score | -1.0 units on a scale | Standard Deviation 1.92 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Composite Score | -0.8 units on a scale | Standard Deviation 1.56 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Composite Score | -0.9 units on a scale | Standard Deviation 1.5 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Composite Score | 4.90 units on a scale | Standard Deviation 1.56 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 General Activity | -0.5 units on a scale | Standard Deviation 1.74 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 General Activity | -1.0 units on a scale | Standard Deviation 1.8 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 General Activity | -1.4 units on a scale | Standard Deviation 2.04 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 General Activity | -1.1 units on a scale | Standard Deviation 1.79 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 General Activity | -1.1 units on a scale | Standard Deviation 2.13 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 General Activity | -0.7 units on a scale | Standard Deviation 2.03 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 General Activity | -1.0 units on a scale | Standard Deviation 1.66 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Walking Ability | 4.4 units on a scale | Standard Deviation 2.32 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Walking Ability | -0.0 units on a scale | Standard Deviation 1.99 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Walking Ability | -0.1 units on a scale | Standard Deviation 2.2 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Walking Ability | -0.7 units on a scale | Standard Deviation 1.92 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Walking Ability | -0.6 units on a scale | Standard Deviation 2 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Walking Ability | -0.5 units on a scale | Standard Deviation 2.46 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Walking Ability | -0.5 units on a scale | Standard Deviation 2.03 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Walking Ability | -0.7 units on a scale | Standard Deviation 1.98 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Normal Work | 5.19 units on a scale | Standard Deviation 1.92 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Normal Work | -0.37 units on a scale | Standard Deviation 2.37 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Normal Work | -1.04 units on a scale | Standard Deviation 1.87 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Normal Work | -1.15 units on a scale | Standard Deviation 2.09 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Normal Work | -0.74 units on a scale | Standard Deviation 2.35 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Normal Work | -0.85 units on a scale | Standard Deviation 2.18 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Normal Work | -0.67 units on a scale | Standard Deviation 1.71 |
| Tanezumab | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Normal Work | -0.70 units on a scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Normal Work | -0.19 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Composite Score | 5.19 units on a scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Walking Ability | 5.5 units on a scale | Standard Deviation 2.04 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Composite Score | -0.8 units on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline Normal Work | 5.69 units on a scale | Standard Deviation 2.26 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Composite Score | -1.1 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Walking Ability | -0.7 units on a scale | Standard Deviation 2.65 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Composite Score | -1.2 units on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Normal Work | -0.69 units on a scale | Standard Deviation 2.72 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Composite Score | -0.9 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Walking Ability | -0.5 units on a scale | Standard Deviation 2.32 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Composite Score | -0.8 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 Normal Work | -0.42 units on a scale | Standard Deviation 2.76 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Composite Score | -0.1 units on a scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Walking Ability | -0.9 units on a scale | Standard Deviation 2.48 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Composite Score | -0.2 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Normal Work | 0.08 units on a scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline General Activity | 5.41 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 Walking Ability | -0.8 units on a scale | Standard Deviation 2.34 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 General Activity | -0.8 units on a scale | Standard Deviation 2.06 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 Normal Work | -0.65 units on a scale | Standard Deviation 2.97 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 General Activity | -0.9 units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Walking Ability | -0.5 units on a scale | Standard Deviation 2.16 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 General Activity | -1.3 units on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 Normal Work | -0.65 units on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 General Activity | -0.9 units on a scale | Standard Deviation 2.15 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 Walking Ability | 0.0 units on a scale | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 General Activity | -0.8 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 Normal Work | -1.23 units on a scale | Standard Deviation 2.52 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 General Activity | -0.1 units on a scale | Standard Deviation 1.53 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 Walking Ability | -0.2 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 General Activity | -0.3 units on a scale | Standard Deviation 1.24 |
Comparison: Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.66695% CI: [-0.77, 1.18]ANCOVA
Comparison: Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.74595% CI: [-0.86, 1.18]ANCOVA
Comparison: Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.74995% CI: [-1.14, 0.83]ANCOVA
Comparison: Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.79495% CI: [-1.16, 0.9]ANCOVA
Comparison: Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.77295% CI: [-1.33, 1]ANCOVA
Comparison: Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.54795% CI: [-0.73, 1.34]ANCOVA
Comparison: Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.6595% CI: [-1.43, 0.91]ANCOVA
Comparison: Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.80895% CI: [-1.27, 1]ANCOVA
Comparison: Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.91595% CI: [-1.19, 1.07]ANCOVA
Comparison: Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.75795% CI: [-1.54, 1.14]ANCOVA
Comparison: Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.98795% CI: [-1.19, 1.17]ANCOVA
Comparison: Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.78195% CI: [-1.14, 1.51]ANCOVA
Comparison: Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.83495% CI: [-1.13, 1.38]ANCOVA
Comparison: Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.85195% CI: [-1.32, 1.1]ANCOVA
Comparison: Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.70195% CI: [-1.68, 1.15]ANCOVA
Comparison: Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.45395% CI: [-1.68, 0.77]ANCOVA
Comparison: Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.25895% CI: [-2.15, 0.6]ANCOVA
Comparison: Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.73695% CI: [-1.53, 1.09]ANCOVA
Comparison: Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.49195% CI: [-1.76, 0.87]ANCOVA
Comparison: Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.69595% CI: [-1.53, 1.04]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to10 (Pain as bad as you can imagine), lower scores indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point NRS at 0 (Does not interfere) to 10 (Completely interferes).
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Here overall number of participants analyzed signifies those participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not performed because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline | 5.2 unit on a scale | Standard Deviation 1.15 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 1 | -0.4 unit on a scale | Standard Deviation 1.65 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 2 | -0.9 unit on a scale | Standard Deviation 1.99 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 4 | -1.0 unit on a scale | Standard Deviation 1.97 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 6 | -1.0 unit on a scale | Standard Deviation 1.54 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 8 | -1.0 unit on a scale | Standard Deviation 1.43 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 12 | -0.9 unit on a scale | Standard Deviation 1.17 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 16 | -0.7 unit on a scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 16 | -0.4 unit on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline | 5.1 unit on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 6 | -0.9 unit on a scale | Standard Deviation 1.78 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 1 | -0.4 unit on a scale | Standard Deviation 1.12 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 12 | -0.5 unit on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 2 | -0.8 unit on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 8 | -0.9 unit on a scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 4 | -1.0 unit on a scale | Standard Deviation 1.84 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.90695% CI: [-0.66, 0.74]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.90695% CI: [-0.95, 0.85]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.61395% CI: [-0.78, 1.29]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.98895% CI: [-0.95, 0.94]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.92295% CI: [-1.01, 0.92]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf average pain measured the severity of pain based on the average pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower score indicates lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Here, overall number of participants analyzed=participants who were evaluable for this measure. number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline | 5.2 unit on a scale | Standard Deviation 1.15 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 1 | -0.6 unit on a scale | Standard Deviation 1.9 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 2 | -1.0 unit on a scale | Standard Deviation 2.12 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 4 | -1.0 unit on a scale | Standard Deviation 2.03 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 6 | -0.9 unit on a scale | Standard Deviation 2 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 8 | -1.6 unit on a scale | Standard Deviation 1.44 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 12 | -1.4 unit on a scale | Standard Deviation 1.29 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 16 | -1.4 unit on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 16 | -1.0 unit on a scale | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline | 5.1 unit on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 6 | -1.1 unit on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 1 | -0.5 unit on a scale | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 12 | -1.0 unit on a scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 2 | -1.0 unit on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 8 | -1.0 unit on a scale | Standard Deviation 1.89 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 4 | -1.0 unit on a scale | Standard Deviation 1.87 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.65595% CI: [-1.03, 0.66]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.89795% CI: [-0.85, 0.96]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.79895% CI: [-0.93, 1.2]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.67295% CI: [-0.83, 1.27]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.24395% CI: [-1.56, 0.41]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores =lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on 11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Missing values were imputed using BOCF method. Here overall number of participants analyzed signifies those participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not performed because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline | 6.1 units on a scale | Standard Deviation 1.54 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 1 | -0.8 units on a scale | Standard Deviation 1.76 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 2 | -1.0 units on a scale | Standard Deviation 1.74 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 4 | -1.2 units on a scale | Standard Deviation 2.01 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 6 | -0.7 units on a scale | Standard Deviation 2.02 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 8 | -1.1 units on a scale | Standard Deviation 2.09 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 12 | -0.4 units on a scale | Standard Deviation 1.48 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 16 | -0.5 units on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 16 | -0.6 units on a scale | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Baseline | 6.0 units on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 6 | -0.7 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 1 | -0.4 units on a scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 12 | -0.7 units on a scale | Standard Deviation 1.77 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 2 | -1.0 units on a scale | Standard Deviation 1.74 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 8 | -0.7 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF | Change at Week 4 | -0.8 units on a scale | Standard Deviation 1.92 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.44595% CI: [-1.16, 0.52]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.99295% CI: [-1, 1]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.65595% CI: [-1.34, 0.86]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.8695% CI: [-1.09, 1.3]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.59595% CI: [-1.52, 0.89]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured magnitude of pain at its worst, least, average, right now. BPI-sf worst pain measured the severity of pain based on the worst pain experienced over the past 24-hours and ranged from 0 (No Pain) to 10 (Pain as bad as you can imagine), lower scores=lesser pain intensity. Question 5: 7 item subsets that measured level of interference of pain on daily functions on11-point numeric rating scale at 0 (Does not interfere) to 10 (Completely interferes).
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline | 6.1 units on a scale | Standard Deviation 1.54 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 1 | -1.1 units on a scale | Standard Deviation 1.99 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 2 | -1.1 units on a scale | Standard Deviation 1.82 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 4 | -1.3 units on a scale | Standard Deviation 2.06 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 6 | -1.1 units on a scale | Standard Deviation 2.42 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 8 | -1.6 units on a scale | Standard Deviation 2.33 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 12 | -1.2 units on a scale | Standard Deviation 2.33 |
| Tanezumab | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 16 | -1.2 units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 16 | -1.0 units on a scale | Standard Deviation 2.32 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Baseline | 6.0 units on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 6 | -1.0 units on a scale | Standard Deviation 2.32 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 1 | -0.5 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 12 | -1.1 units on a scale | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 2 | -1.3 units on a scale | Standard Deviation 1.86 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 8 | -1.0 units on a scale | Standard Deviation 2.11 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF | Change at Week 4 | -0.9 units on a scale | Standard Deviation 1.95 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.17995% CI: [-1.76, 0.35]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.93895% CI: [-1.02, 1.1]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.62195% CI: [-1.41, 0.86]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.86395% CI: [-1.44, 1.21]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.23795% CI: [-1.95, 0.51]ANCOVA
Secondary
Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser pain intensity.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. For time points after Week 8, inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -0.8 units on a scale | Standard Deviation 0.85 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -0.9 units on a scale | Standard Deviation 1.08 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -1.3 units on a scale | Standard Deviation 1.58 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -1.4 units on a scale | Standard Deviation 1.73 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -1.0 units on a scale | Standard Deviation 1.56 |
| Tanezumab | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -0.8 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -0.4 units on a scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -0.6 units on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -0.9 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -0.8 units on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -0.4 units on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -1.2 units on a scale | Standard Deviation 1.46 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.58195% CI: [-0.6, 0.34]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.79595% CI: [-0.56, 0.73]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.84395% CI: [-0.76, 0.93]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.29295% CI: [-1.34, 0.42]ANCOVA
Secondary
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
The worst pain was assessed an 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower the score, lesser pain intensity.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.3 units on a scale | Standard Deviation 1.3 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 1 | -0.8 units on a scale | Standard Deviation 0.87 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.8 units on a scale | Standard Deviation 1.32 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.2 units on a scale | Standard Deviation 1.7 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 6 | -1.0 units on a scale | Standard Deviation 1.82 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.1 units on a scale | Standard Deviation 1.77 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.7 units on a scale | Standard Deviation 1.4 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.5 units on a scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -0.4 units on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline | 6.4 units on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 6 | -0.9 units on a scale | Standard Deviation 1.52 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 1 | -0.6 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.4 units on a scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.0 units on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.9 units on a scale | Standard Deviation 1.53 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.2 units on a scale | Standard Deviation 1.4 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.29995% CI: [-0.72, 0.23]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.51995% CI: [-0.47, 0.91]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.77695% CI: [-0.74, 0.98]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.97895% CI: [-0.93, 0.91]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.68995% CI: [-1.1, 0.73]ANCOVA
Secondary
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)
The worst pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the lesser pain intensity.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using LOCF method. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Baseline | 6.3 units on a scale | Standard Deviation 1.3 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 1 | -0.8 units on a scale | Standard Deviation 0.87 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.8 units on a scale | Standard Deviation 1.32 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.1 units on a scale | Standard Deviation 1.8 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 6 | -1.0 units on a scale | Standard Deviation 1.91 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.1 units on a scale | Standard Deviation 1.86 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.8 units on a scale | Standard Deviation 1.86 |
| Tanezumab | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.7 units on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.2 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Baseline | 6.4 units on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 6 | -1.1 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 1 | -0.6 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.3 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.0 units on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.1 units on a scale | Standard Deviation 1.68 |
| Placebo | Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.3 units on a scale | Standard Deviation 1.45 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.29995% CI: [-0.72, 0.23]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.51995% CI: [-0.47, 0.91]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.61895% CI: [-0.68, 1.13]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.81895% CI: [-0.85, 1.07]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.p-value: 0.81995% CI: [-0.87, 1.09]ANCOVA
Secondary
Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16
OR-SDS: participant-rated levels of frequency (F), severity (S), degree of bother (DoB) for 10 symptoms: fatigue, drowsiness, concentration, confusion, nausea, dizziness, constipation, itching, difficulty with urination, retching/vomiting. For each symptom levels of F, S and DoB scored as: frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'). Mean of F, S and DoB was calculated for each symptom to derive composite scores/multi-domain average (MDA) scores which ranges from 0 to 4.33. Higher MDA=worse symptom. Composite scores for frequency (FCS), severity (SCS), degree of bother, and MDA were calculated as mean of these scores across 10 symptoms and had same ranges as individual scores frequency (0 to 4:'did not have' to 'almost constantly'), severity (0 to 4:'did not have' to 'very severe'), degree of bother (0 to 5:'did not have' to 'very much'); higher scores=more distress
Time frame: Baseline, Week 2, 4, 6, 12, 16
Population: ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points; 0 in number analyzed field signifies no participant was evaluable for the parameter at this time point. For time points after Week 6 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline MDA Composite Score | 1.90 units on a scale | Standard Deviation 0.49 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Constipation MDA | 1.96 units on a scale | Standard Deviation 0.77 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Constipation MDA | -0.1 units on a scale | Standard Deviation 1.31 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 MDA Composite Score | -0.0 units on a scale | Standard Deviation 0.46 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 MDA Composite Score | 0.0 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 MDA Composite Score | -0.1 units on a scale | Standard Deviation 0.42 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 MDA Composite Score | -0.1 units on a scale | Standard Deviation 0.57 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 MDA Composite Score | -0.2 units on a scale | Standard Deviation 0.88 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Fatigue MDA | 2.05 units on a scale | Standard Deviation 0.61 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Fatigue MDA | 0.1 units on a scale | Standard Deviation 0.46 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Fatigue MDA | -0.2 units on a scale | Standard Deviation 0.58 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Fatigue MDA | -0.3 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Fatigue MDA | -0.3 units on a scale | Standard Deviation 0.53 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Fatigue MDA | -0.5 units on a scale | Standard Deviation 0.58 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Drowsiness MDA | 1.89 units on a scale | Standard Deviation 0.7 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Drowsiness MDA | -0.1 units on a scale | Standard Deviation 0.66 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Drowsiness MDA | 0.1 units on a scale | Standard Deviation 0.89 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Drowsiness MDA | 0.0 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Drowsiness MDA | -0.3 units on a scale | Standard Deviation 0.77 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Drowsiness MDA | -0.6 units on a scale | Standard Deviation 0.92 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Inability to concentrate (ITC) MDA | 1.53 units on a scale | Standard Deviation 0.65 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 ITC MDA | 0.2 units on a scale | Standard Deviation 0.4 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 ITC MDA | 0.1 units on a scale | Standard Deviation 0.98 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 ITC MDA | 0.2 units on a scale | Standard Deviation 0.81 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 ITC MDA | -0.2 units on a scale | Standard Deviation 0.84 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 ITC MDA | -0.1 units on a scale | Standard Deviation 1.07 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Nausea MDA | 2.18 units on a scale | Standard Deviation 0.7 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Nausea MDA | -0.0 units on a scale | Standard Deviation 0.77 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Nausea MDA | 0.1 units on a scale | Standard Deviation 0.34 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Nausea MDA | -0.7 units on a scale | Standard Deviation 0.67 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Dizziness MDA | 1.70 units on a scale | Standard Deviation 0.42 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Dizziness MDA | 0.5 units on a scale | Standard Deviation 0.46 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Dizziness MDA | 0.5 units on a scale | Standard Deviation 0.8 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Dizziness MDA | 0.5 units on a scale | Standard Deviation 0.24 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Constipation MDA | 0.5 units on a scale | Standard Deviation 0.88 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Constipation MDA | 0.5 units on a scale | Standard Deviation 0.9 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Constipation MDA | -0.2 units on a scale | Standard Deviation 0.8 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Constipation MDA | 1.2 units on a scale | Standard Deviation 1.65 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Itching MDA | 1.83 units on a scale | Standard Deviation 0.58 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Itching MDA | 0.0 units on a scale | Standard Deviation 0 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Itching MDA | -1.0 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Itching MDA | -0.7 units on a scale | Standard Deviation 0.94 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Difficulty with urination(DWU) MDA | 1.58 units on a scale | Standard Deviation 0.5 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 DWU MDA | 0.5 units on a scale | Standard Deviation 0.79 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 DWU MDA | 0.9 units on a scale | Standard Deviation 1.1 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 DWU MDA | 0.3 units on a scale | Standard Deviation 0.94 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 DWU MDA | -0.3 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Confusion MDA | 1.67 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Confusion MDA | -0.7 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Confusion MDA | -0.7 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Confusion MDA | -0.7 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Confusion MDA | -0.7 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Retching/Vomiting MDA | 2.56 units on a scale | Standard Deviation 0.69 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Retching/Vomiting MDA | 0.2 units on a scale | Standard Deviation 0.24 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Retching/Vomiting MDA | -0.7 units on a scale | Standard Deviation 0.47 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Retching/Vomiting MDA | -0.3 units on a scale | — |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Frequency Composite Score (FCS) | 1.82 units on a scale | Standard Deviation 0.52 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 FCS | -0.0 units on a scale | Standard Deviation 0.55 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 FCS | -0.0 units on a scale | Standard Deviation 0.76 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 FCS | -0.3 units on a scale | Standard Deviation 0.55 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 FCS | -0.3 units on a scale | Standard Deviation 0.48 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 FCS | -0.2 units on a scale | Standard Deviation 0.88 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Severity Composite Score (SCS) | 1.60 units on a scale | Standard Deviation 0.5 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 SCS | 0.0 units on a scale | Standard Deviation 0.53 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 SCS | 0.1 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 SCS | -0.0 units on a scale | Standard Deviation 0.44 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 SCS | 0.0 units on a scale | Standard Deviation 0.31 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 SCS | 0.0 units on a scale | Standard Deviation 0.97 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Bother Composite Score | 2.29 units on a scale | Standard Deviation 0.74 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Bother Composite Score | -0.0 units on a scale | Standard Deviation 0.61 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Bother Composite Score | -0.0 units on a scale | Standard Deviation 0.79 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Bother Composite Score | -0.1 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Bother Composite Score | -0.1 units on a scale | Standard Deviation 1.05 |
| Tanezumab | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Bother Composite Score | -0.4 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Constipation MDA | -0.5 units on a scale | Standard Deviation 1.73 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 SCS | -0.1 units on a scale | Standard Deviation 0.44 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Constipation MDA | 0.0 units on a scale | — |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Frequency Composite Score (FCS) | 2.14 units on a scale | Standard Deviation 0.73 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Dizziness MDA | -0.2 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Itching MDA | 1.83 units on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Constipation MDA | 2.40 units on a scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Bother Composite Score | -0.1 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline MDA Composite Score | 2.14 units on a scale | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Itching MDA | -0.2 units on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 MDA Composite Score | -0.1 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 FCS | -0.2 units on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 MDA Composite Score | -0.1 units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Itching MDA | 0.2 units on a scale | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 MDA Composite Score | -0.1 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 SCS | -0.3 units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 MDA Composite Score | -0.4 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Itching MDA | 0.3 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 MDA Composite Score | -0.3 units on a scale | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 FCS | -0.0 units on a scale | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Fatigue MDA | 2.33 units on a scale | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Difficulty with urination(DWU) MDA | 2.27 units on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Fatigue MDA | -0.3 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Dizziness MDA | -0.3 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Fatigue MDA | -0.2 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 DWU MDA | 0.0 units on a scale | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Fatigue MDA | -0.2 units on a scale | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 FCS | -0.1 units on a scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Fatigue MDA | -0.4 units on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 DWU MDA | 0.0 units on a scale | — |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Fatigue MDA | -0.4 units on a scale | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 SCS | -0.1 units on a scale | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Drowsiness MDA | 2.43 units on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 DWU MDA | -0.8 units on a scale | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Drowsiness MDA | -0.4 units on a scale | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 FCS | -0.4 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Drowsiness MDA | -0.2 units on a scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 DWU MDA | 0.0 units on a scale | — |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Drowsiness MDA | -0.3 units on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 DWU MDA | -0.7 units on a scale | — |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Drowsiness MDA | -0.9 units on a scale | Standard Deviation 0.96 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Bother Composite Score | -0.2 units on a scale | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Drowsiness MDA | -0.5 units on a scale | Standard Deviation 0.64 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Confusion MDA | 1.67 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Inability to concentrate (ITC) MDA | 2.02 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 FCS | -0.2 units on a scale | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 ITC MDA | -0.2 units on a scale | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Confusion MDA | -0.4 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 ITC MDA | -0.3 units on a scale | Standard Deviation 0.23 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Bother Composite Score | 2.49 units on a scale | Standard Deviation 0.73 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 ITC MDA | -0.1 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Confusion MDA | -0.2 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 ITC MDA | -0.3 units on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Severity Composite Score (SCS) | 1.78 units on a scale | Standard Deviation 0.42 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 ITC MDA | -0.5 units on a scale | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Confusion MDA | 0.3 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Nausea MDA | 2.08 units on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Bother Composite Score | -0.6 units on a scale | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Nausea MDA | 0.0 units on a scale | Standard Deviation 0.67 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 16 Confusion MDA | 0.3 units on a scale | — |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Nausea MDA | -0.2 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 SCS | 0.0 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Nausea MDA | 0.6 units on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Retching/Vomiting MDA | 2.06 units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Baseline Dizziness MDA | 1.70 units on a scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Bother Composite Score | -0.1 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Dizziness MDA | 0.0 units on a scale | Standard Deviation 0.36 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Retching/Vomiting MDA | -0.7 units on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Dizziness MDA | -0.3 units on a scale | Standard Deviation 0.37 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 SCS | -0.1 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Dizziness MDA | -0.2 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 2 Constipation MDA | 0.1 units on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Retching/Vomiting MDA | 0.0 units on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 4 Constipation MDA | -0.2 units on a scale | Standard Deviation 0.67 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 12 Bother Composite Score | -0.5 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Constipation MDA | 0.0 units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16 | Change at Week 6 Retching/Vomiting MDA | 0.7 units on a scale | Standard Deviation 0.94 |
Comparison: Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.21595% CI: [-0.13, 0.55]ANCOVA
Comparison: Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.94795% CI: [-0.45, 0.42]ANCOVA
Comparison: Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.34195% CI: [-0.56, 0.2]ANCOVA
Comparison: Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.1895% CI: [-0.83, 0.17]ANCOVA
Comparison: Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.50995% CI: [-0.43, 0.84]ANCOVA
Comparison: Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.76795% CI: [-0.62, 0.82]ANCOVA
Comparison: Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.10895% CI: [-0.11, 0.95]ANCOVA
Comparison: Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.2895% CI: [-1.26, 0.41]ANCOVA
Comparison: Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.74795% CI: [-1.53, 1.15]ANCOVA
Comparison: Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.99195% CI: [-0.87, 0.88]ANCOVA
Comparison: Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.33595% CI: [-0.41, 0.99]ANCOVA
Comparison: Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.15995% CI: [-4.57, 1.48]ANCOVA
Comparison: Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.13695% CI: [-0.16, 0.94]ANCOVA
Comparison: Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.18695% CI: [-3.46, 5.9]ANCOVA
Comparison: Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.29295% CI: [-1.52, 0.49]ANCOVA
Comparison: Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.22595% CI: [-0.34, 1.3]ANCOVA
Comparison: Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.51795% CI: [-0.58, 1.07]ANCOVA
Comparison: Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 195% CI: [-2.48, 2.48]ANCOVA
Comparison: Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: <0.00195% CI: [-1.01, -0.99]ANCOVA
Comparison: Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.36295% CI: [-0.75, 1.63]ANCOVA
Comparison: Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 195% CI: [-51.87, 51.87]ANCOVA
Comparison: Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.03195% CI: [-3.3, -0.76]ANCOVA
Comparison: Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.88695% CI: [-0.28, 0.32]ANCOVA
Comparison: Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.6695% CI: [-0.52, 0.33]ANCOVA
Comparison: Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.23895% CI: [-0.54, 0.14]ANCOVA
Comparison: Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.3695% CI: [-0.42, 0.16]ANCOVA
Comparison: Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.27895% CI: [-0.16, 0.54]ANCOVA
Comparison: Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.80995% CI: [-0.34, 0.27]ANCOVA
Comparison: Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.94495% CI: [-0.35, 0.38]ANCOVA
Comparison: Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.89295% CI: [-0.48, 0.55]ANCOVA
Comparison: Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.88495% CI: [-0.39, 0.45]ANCOVA
Comparison: Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.91995% CI: [-0.26, 0.28]ANCOVA
Comparison: Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.75295% CI: [-0.33, 0.45]ANCOVA
Comparison: Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.p-value: 0.71595% CI: [-0.34, 0.24]ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Missing data were imputed using BOCF method. Here overall number of participants analyzed signifies participants evaluable for this measure. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline | 3.26 units on a scale | Standard Deviation 0.66 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 | -0.4 units on a scale | Standard Deviation 0.8 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 | -0.4 units on a scale | Standard Deviation 0.57 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 | -0.3 units on a scale | Standard Deviation 0.91 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 | -0.3 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 | -0.4 units on a scale | Standard Deviation 0.63 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 | -0.2 units on a scale | Standard Deviation 0.51 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 | -0.5 units on a scale | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 16 | -0.0 units on a scale | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Baseline | 2.92 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 1 | 0.2 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 2 | 0.0 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 4 | -0.2 units on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 6 | -0.3 units on a scale | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 8 | -0.1 units on a scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF | Change at Week 12 | -0.1 units on a scale | Standard Deviation 0.48 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.10895% CI: [-0.82, 0.09]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.20295% CI: [-0.7, 0.16]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.57195% CI: [-0.54, 0.3]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.80895% CI: [-0.55, 0.43]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.91395% CI: [-0.57, 0.51]ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time frame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Missing values were imputed using LOCF method. Here overall number of participants analyzed signifies participants who were evaluable for this measure. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline | 3.26 units on a scale | Standard Deviation 0.66 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 | -0.3 units on a scale | Standard Deviation 0.62 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 | -0.4 units on a scale | Standard Deviation 0.58 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 | -0.5 units on a scale | Standard Deviation 0.75 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 | -0.5 units on a scale | Standard Deviation 0.85 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 | -0.4 units on a scale | Standard Deviation 1.01 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 | -0.4 units on a scale | Standard Deviation 0.84 |
| Tanezumab | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 | -0.3 units on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 16 | -0.1 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Baseline | 2.92 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 6 | -0.2 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 1 | 0.2 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 12 | -0.1 units on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 2 | -0.0 units on a scale | Standard Deviation 0.96 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 8 | 0.0 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF | Change at Week 4 | -0.1 units on a scale | Standard Deviation 1.07 |
Comparison: Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.10895% CI: [-0.82, 0.09]ANCOVA
Comparison: Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.33995% CI: [-0.65, 0.23]ANCOVA
Comparison: Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.40895% CI: [-0.67, 0.28]ANCOVA
Comparison: Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.68695% CI: [-0.67, 0.45]ANCOVA
Comparison: Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.p-value: 0.49395% CI: [-0.81, 0.4]ANCOVA
Secondary
Electrocardiogram Examination
ECG intervals included: RR (the time interval between consecutive heart beats), PR (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS (represented ventricular depolarization) and QT (time corresponding to the beginning of depolarization to repolarization of the ventricles), QTcF (QT interval corrected using Fridericia's formula \[FF\]), QTcB interval (QT interval corrected using Bazett's formula \[BF\]).
Time frame: Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies participants who were evaluable for this measure; number analyzed =participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose QT interval | 375.6 millisecond (msec) | Standard Deviation 33.19 |
| Tanezumab | Electrocardiogram Examination | Week 16 PR interval | 169.7 millisecond (msec) | Standard Deviation 32.67 |
| Tanezumab | Electrocardiogram Examination | Baseline 1 hour Post-dose QT interval | 388.9 millisecond (msec) | Standard Deviation 34.08 |
| Tanezumab | Electrocardiogram Examination | Baseline 1 hour Post-dose RR interval | 774.9 millisecond (msec) | Standard Deviation 143.62 |
| Tanezumab | Electrocardiogram Examination | Week 4 QT interval | 383.7 millisecond (msec) | Standard Deviation 36.19 |
| Tanezumab | Electrocardiogram Examination | Early Termination PR interval | 164.0 millisecond (msec) | Standard Deviation 20.99 |
| Tanezumab | Electrocardiogram Examination | Week 16 QT interval | 386.2 millisecond (msec) | Standard Deviation 25.93 |
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose PR interval | 162.2 millisecond (msec) | Standard Deviation 27.83 |
| Tanezumab | Electrocardiogram Examination | Early Termination QT interval | 392.3 millisecond (msec) | Standard Deviation 42.72 |
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose QRS complex | 89.5 millisecond (msec) | Standard Deviation 10.53 |
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose QTCB interval BF | 437.9 millisecond (msec) | Standard Deviation 22.08 |
| Tanezumab | Electrocardiogram Examination | Week 16 RR interval | 805.4 millisecond (msec) | Standard Deviation 143.66 |
| Tanezumab | Electrocardiogram Examination | Baseline 1hour Post-dose QTCB interval BF | 438.4 millisecond (msec) | Standard Deviation 19.46 |
| Tanezumab | Electrocardiogram Examination | Baseline 1 hour Post-dose QRS complex | 90.6 millisecond (msec) | Standard Deviation 10.54 |
| Tanezumab | Electrocardiogram Examination | Week 4 QTCB interval BF | 439.5 millisecond (msec) | Standard Deviation 24.83 |
| Tanezumab | Electrocardiogram Examination | Baseline 1 hour Post-dose PR interval | 163.6 millisecond (msec) | Standard Deviation 22.66 |
| Tanezumab | Electrocardiogram Examination | Week 16 QTCB interval BF | 435.1 millisecond (msec) | Standard Deviation 22.31 |
| Tanezumab | Electrocardiogram Examination | Week 4 QRS complex | 89.0 millisecond (msec) | Standard Deviation 9.97 |
| Tanezumab | Electrocardiogram Examination | Early Termination QTCB interval BF | 440.5 millisecond (msec) | Standard Deviation 24.86 |
| Tanezumab | Electrocardiogram Examination | Week 4 RR interval | 774.1 millisecond (msec) | Standard Deviation 161.87 |
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose QTCB interval FF | 415.6 millisecond (msec) | Standard Deviation 19.5 |
| Tanezumab | Electrocardiogram Examination | Week 16 QRS complex | 87.6 millisecond (msec) | Standard Deviation 11.93 |
| Tanezumab | Electrocardiogram Examination | Baseline 1hour Post-dose QTCB interval FF | 420.8 millisecond (msec) | Standard Deviation 20.05 |
| Tanezumab | Electrocardiogram Examination | Week 4 PR interval | 162.2 millisecond (msec) | Standard Deviation 27.29 |
| Tanezumab | Electrocardiogram Examination | Week 4 QTCB interval FF | 419.5 millisecond (msec) | Standard Deviation 21.64 |
| Tanezumab | Electrocardiogram Examination | Early Termination QRS complex | 88.7 millisecond (msec) | Standard Deviation 10.33 |
| Tanezumab | Electrocardiogram Examination | Week 16 QTCB interval FF | 417.7 millisecond (msec) | Standard Deviation 15.59 |
| Tanezumab | Electrocardiogram Examination | Early Termination RR interval | 805.0 millisecond (msec) | Standard Deviation 164.26 |
| Tanezumab | Electrocardiogram Examination | Early Termination QTCB interval FF | 423.3 millisecond (msec) | Standard Deviation 25.07 |
| Tanezumab | Electrocardiogram Examination | Baseline Pre-dose RR interval | 742.7 millisecond (msec) | Standard Deviation 146.23 |
| Placebo | Electrocardiogram Examination | Early Termination QTCB interval FF | 424.1 millisecond (msec) | Standard Deviation 20.93 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose RR interval | 767.7 millisecond (msec) | Standard Deviation 153.09 |
| Placebo | Electrocardiogram Examination | Baseline 1 hour Post-dose RR interval | 792.5 millisecond (msec) | Standard Deviation 157.81 |
| Placebo | Electrocardiogram Examination | Week 4 RR interval | 777.2 millisecond (msec) | Standard Deviation 161.81 |
| Placebo | Electrocardiogram Examination | Week 16 RR interval | 828.8 millisecond (msec) | Standard Deviation 150.78 |
| Placebo | Electrocardiogram Examination | Early Termination RR interval | 760.2 millisecond (msec) | Standard Deviation 152.61 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose PR interval | 151.6 millisecond (msec) | Standard Deviation 15.82 |
| Placebo | Electrocardiogram Examination | Baseline 1 hour Post-dose PR interval | 153.1 millisecond (msec) | Standard Deviation 18.26 |
| Placebo | Electrocardiogram Examination | Week 4 PR interval | 150.0 millisecond (msec) | Standard Deviation 17.44 |
| Placebo | Electrocardiogram Examination | Week 16 PR interval | 145.4 millisecond (msec) | Standard Deviation 16.27 |
| Placebo | Electrocardiogram Examination | Early Termination PR interval | 151.6 millisecond (msec) | Standard Deviation 17.6 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose QRS complex | 93.7 millisecond (msec) | Standard Deviation 10.6 |
| Placebo | Electrocardiogram Examination | Baseline 1 hour Post-dose QRS complex | 94.0 millisecond (msec) | Standard Deviation 11.53 |
| Placebo | Electrocardiogram Examination | Week 4 QRS complex | 92.2 millisecond (msec) | Standard Deviation 10.28 |
| Placebo | Electrocardiogram Examination | Week 16 QRS complex | 94.5 millisecond (msec) | Standard Deviation 9.12 |
| Placebo | Electrocardiogram Examination | Early Termination QRS complex | 93.0 millisecond (msec) | Standard Deviation 11.1 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose QT interval | 384.6 millisecond (msec) | Standard Deviation 38.26 |
| Placebo | Electrocardiogram Examination | Baseline 1 hour Post-dose QT interval | 389.9 millisecond (msec) | Standard Deviation 36.38 |
| Placebo | Electrocardiogram Examination | Week 4 QT interval | 384.6 millisecond (msec) | Standard Deviation 38.33 |
| Placebo | Electrocardiogram Examination | Week 16 QT interval | 394.2 millisecond (msec) | Standard Deviation 33.98 |
| Placebo | Electrocardiogram Examination | Early Termination QT interval | 385.8 millisecond (msec) | Standard Deviation 34.97 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose QTCB interval BF | 441.6 millisecond (msec) | Standard Deviation 23.19 |
| Placebo | Electrocardiogram Examination | Baseline 1hour Post-dose QTCB interval BF | 440.7 millisecond (msec) | Standard Deviation 23.1 |
| Placebo | Electrocardiogram Examination | Week 4 QTCB interval BF | 439.0 millisecond (msec) | Standard Deviation 22.47 |
| Placebo | Electrocardiogram Examination | Week 16 QTCB interval BF | 434.9 millisecond (msec) | Standard Deviation 13.33 |
| Placebo | Electrocardiogram Examination | Early Termination QTCB interval BF | 445.5 millisecond (msec) | Standard Deviation 23.89 |
| Placebo | Electrocardiogram Examination | Baseline Pre-dose QTCB interval FF | 421.3 millisecond (msec) | Standard Deviation 22.97 |
| Placebo | Electrocardiogram Examination | Baseline 1hour Post-dose QTCB interval FF | 422.7 millisecond (msec) | Standard Deviation 21.73 |
| Placebo | Electrocardiogram Examination | Week 4 QTCB interval FF | 419.6 millisecond (msec) | Standard Deviation 22.07 |
| Placebo | Electrocardiogram Examination | Week 16 QTCB interval FF | 420.6 millisecond (msec) | Standard Deviation 14.71 |
Secondary
Electrocardiogram Examination: Heart Rate
Standard 12-lead ECG performed after participant had rested quietly for at least 10 minutes in a supine position was measured. The time interval between consecutive heart beats \[RR interval\] (in beats per minute \[bpm\]) was used to calculate heart rate.
Time frame: Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Electrocardiogram Examination: Heart Rate | Baseline 1 hour Post-dose | 80.1 bpm | Standard Deviation 15.33 |
| Tanezumab | Electrocardiogram Examination: Heart Rate | Week 16 | 77.0 bpm | Standard Deviation 13.69 |
| Tanezumab | Electrocardiogram Examination: Heart Rate | Week 4 | 80.9 bpm | Standard Deviation 16.75 |
| Tanezumab | Electrocardiogram Examination: Heart Rate | Early Termination | 77.6 bpm | Standard Deviation 16.25 |
| Tanezumab | Electrocardiogram Examination: Heart Rate | Baseline Pre-dose | 84.0 bpm | Standard Deviation 16.89 |
| Placebo | Electrocardiogram Examination: Heart Rate | Early Termination | 81.9 bpm | Standard Deviation 15.64 |
| Placebo | Electrocardiogram Examination: Heart Rate | Baseline Pre-dose | 81.1 bpm | Standard Deviation 15.33 |
| Placebo | Electrocardiogram Examination: Heart Rate | Baseline 1 hour Post-dose | 78.5 bpm | Standard Deviation 14.57 |
| Placebo | Electrocardiogram Examination: Heart Rate | Week 4 | 80.2 bpm | Standard Deviation 14.99 |
| Placebo | Electrocardiogram Examination: Heart Rate | Week 16 | 74.4 bpm | Standard Deviation 12.71 |
Secondary
Number of Doses of Rescue Medication Required Per Week
Participants received immediate release (IR) opioid as rescue medication as needed for breakthrough pain from Day 1-113 at the dose determined during the pre-treatment phase, provided the average total daily dose of opioids between study visits does not exceed the baseline total daily opioid dose by more than 10%.
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
Population: ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 1 | 9.5 doses per week | Standard Deviation 16.16 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 9 | 5.2 doses per week | Standard Deviation 5.61 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 5 | 5.5 doses per week | Standard Deviation 5.62 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 10 | 11.0 doses per week | Standard Deviation 23.22 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 3 | 8.9 doses per week | Standard Deviation 17.46 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 11 | 12.1 doses per week | Standard Deviation 23.75 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 6 | 4.8 doses per week | Standard Deviation 5.59 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 12 | 12.6 doses per week | Standard Deviation 24.22 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 2 | 9.0 doses per week | Standard Deviation 16.57 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 13 | 5.8 doses per week | Standard Deviation 6.06 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 7 | 5.9 doses per week | Standard Deviation 5.96 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 14 | 5.9 doses per week | Standard Deviation 7.3 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 4 | 9.0 doses per week | Standard Deviation 17.24 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 15 | 4.9 doses per week | Standard Deviation 6.55 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 8 | 5.8 doses per week | Standard Deviation 6.08 |
| Tanezumab | Number of Doses of Rescue Medication Required Per Week | Week 16 | 6.6 doses per week | Standard Deviation 8.35 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 16 | 2.3 doses per week | Standard Deviation 4.04 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 1 | 5.6 doses per week | Standard Deviation 6.21 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 2 | 5.0 doses per week | Standard Deviation 6.24 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 3 | 5.2 doses per week | Standard Deviation 6.88 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 4 | 6.6 doses per week | Standard Deviation 10.82 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 5 | 7.1 doses per week | Standard Deviation 10.47 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 6 | 8.0 doses per week | Standard Deviation 11.25 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 7 | 9.0 doses per week | Standard Deviation 12.49 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 8 | 9.9 doses per week | Standard Deviation 12.04 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 9 | 3.8 doses per week | Standard Deviation 4.23 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 10 | 3.3 doses per week | Standard Deviation 3.98 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 11 | 4.7 doses per week | Standard Deviation 5.5 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 12 | 4.7 doses per week | Standard Deviation 4.46 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 13 | 4.0 doses per week | Standard Deviation 3.81 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 14 | 2.5 doses per week | Standard Deviation 3 |
| Placebo | Number of Doses of Rescue Medication Required Per Week | Week 15 | 3.0 doses per week | Standard Deviation 5.2 |
Comparison: Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.18895% CI: [0.77, 3.73]Negative binomial regression
Comparison: Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.20795% CI: [0.72, 4.54]Negative binomial regression
Comparison: Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.31795% CI: [0.6, 4.93]Negative binomial regression
Comparison: Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.55495% CI: [0.5, 3.71]Negative binomial regression
Comparison: Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.58195% CI: [0.32, 1.89]Negative binomial regression
Comparison: Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.25295% CI: [0.26, 1.43]Negative binomial regression
Comparison: Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.36595% CI: [0.26, 1.64]Negative binomial regression
Comparison: Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.p-value: 0.21295% CI: [0.25, 1.36]Negative binomial regression
Secondary
Number of Participants With Abnormal Laboratory Examination
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (\<0.8\*lower limit of normal \[LLN\]); red blood cell count (\<0.8\*LLN); platelets (\<0.5\*LLN or \>1.75\* upper limit of normal \[ULN\]); leucocytes (\<0.6\*LLN or \>1.5\*ULN); lymphocytes, total neutrophils (\<0.8\*LLN or \>1.2\*ULN); basophils, eosinophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (\>3\*ULN); creatinine, blood urea nitrogen (\>1.3\*ULN); glucose (\<0.6\*LLN or \>1.5\*ULN); uric acid (\>1.2\*ULN); sodium (\<0.95\*LLN or 1.05\*ULN); potassium, calcium, chloride, bicarbonate (\<0.9\*LLN or 1.1\*ULN); albumin, total protein (\<0.8\*LLN or 1.2\*ULN); urine analysis. Total number of participants without regards to baseline abnormality was summarized.
Time frame: Baseline up to Week 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants With Abnormal Laboratory Examination | 27 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Examination | 29 Participants |
Secondary
Number of Participants With Abnormal Neurological Examination
Neurological examinations assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index finger and great toes in order to complete the neuropathy impairment score (NIS). NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis) for muscle strength, higher score indicated higher abnormality/impairment, and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent) for sensation, higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Time frame: Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Week 2 | 1 participants |
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Week 4 | 2 participants |
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Week 6 | 1 participants |
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Week 12 | 1 participants |
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Week 16 | 0 participants |
| Tanezumab | Number of Participants With Abnormal Neurological Examination | Early Termination | 3 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Week 16 | 1 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Week 2 | 3 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Week 12 | 1 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Week 4 | 3 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Early Termination | 4 participants |
| Placebo | Number of Participants With Abnormal Neurological Examination | Week 6 | 5 participants |
Secondary
Number of Participants With Anti-drug Antibodies
Human serum samples were analyzed using electrochemiluminescent (ECL) immunoassay for the presence of anti-tanezumab antibodies. Same participant may have positive (titer value \>=4.32) anti-tanezumab antibodies result at more than 1 time point.
Time frame: Baseline (Day 1), Week 4, 6, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure. 'number analyzed'=participants evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab | Number of Participants With Anti-drug Antibodies | Baseline | 0 Participants |
| Tanezumab | Number of Participants With Anti-drug Antibodies | Week 4 | 1 Participants |
| Tanezumab | Number of Participants With Anti-drug Antibodies | Week 6 | 0 Participants |
| Tanezumab | Number of Participants With Anti-drug Antibodies | Week 12 | 0 Participants |
| Tanezumab | Number of Participants With Anti-drug Antibodies | Week 16 | 1 Participants |
Secondary
Number of Participants With Physical Examination Abnormalities
Physical examinations included general appearance (skin, neck, eyes, ears, nose, throat), cardiovascular system (including rhythm and presence of other cardiac abnormalities, such as gallops, murmurs, and cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system, and any additional assessments necessary to establish baseline status or evaluate symptoms or adverse experiences. Abnormalities in physical examination was based on investigator's discretion.
Time frame: Baseline up to Week 16 or Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab | Number of Participants With Physical Examination Abnormalities | 2 Participants |
| Placebo | Number of Participants With Physical Examination Abnormalities | 8 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 113 days that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 113 days
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 18 participants |
| Tanezumab | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 7 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 18 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 4 participants |
Secondary
Patient's Global Evaluation of Study Medication
The Patient's Global Evaluation of Study Medication (PGESM) was a single item that assessed the participant's perception of his/her response to the study medication. It was a self-administered question that utilizes a 4-point Likert scale from 1=Poor to 4=Excellent, where higher score represented better outcome.
Time frame: Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Overall number of participants analyzed=participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points. For time points after Week 8 inferential statistics were not done as post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 4 | 2.4 units on a scale | Standard Deviation 0.64 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 8 | 2.7 units on a scale | Standard Deviation 0.83 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 2 | 2.6 units on a scale | Standard Deviation 0.82 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 12 | 2.5 units on a scale | Standard Deviation 0.75 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 6 | 2.5 units on a scale | Standard Deviation 0.75 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 16 | 2.6 units on a scale | Standard Deviation 0.8 |
| Tanezumab | Patient's Global Evaluation of Study Medication | Week 1 | 2.7 units on a scale | Standard Deviation 0.91 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 16 | 2.4 units on a scale | Standard Deviation 0.94 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 1 | 2.3 units on a scale | Standard Deviation 0.81 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 2 | 2.4 units on a scale | Standard Deviation 0.94 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 4 | 2.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 6 | 2.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 8 | 2.2 units on a scale | Standard Deviation 0.86 |
| Placebo | Patient's Global Evaluation of Study Medication | Week 12 | 2.3 units on a scale | Standard Deviation 0.89 |
Comparison: Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.p-value: 0.399Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was calculated by CMH test stratified by center.p-value: 0.779Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was calculated by CMH test stratified by center.p-value: 0.922Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was calculated by CMH test stratified by center.p-value: 0.811Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was calculated by CMH test stratified by center.p-value: 0.237Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF
Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower scores indicate less pain intensity.
Time frame: Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using BOCF method. Data was not summarized statistically at week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=30% reduction | 10.3 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=50% reduction | 3.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=70% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=30% reduction | 24.1 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=50% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=70% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=30% reduction | 44.8 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=50% reduction | 27.6 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=70% reduction | 3.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=30% reduction | 14.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=50% reduction | 27.6 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=70% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=30% reduction | 48.3 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=50% reduction | 34.5 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=70% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=50% reduction | 16.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=30% reduction | 13.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=70% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=50% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=90% reduction | 3.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=70% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 1: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=90% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=30% reduction | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=30% reduction | 33.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=50% reduction | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=30% reduction | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=70% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=50% reduction | 20.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 2: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 8: >=70% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=30% reduction | 36.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 6: >=70% reduction | 3.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF | Week 4: >=50% reduction | 16.7 percentage of participants |
Comparison: Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.1, 4.94]Fisher Exact
Comparison: Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.23, 3.32]Fisher Exact
Comparison: Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.05, 6.35]Fisher Exact
Comparison: Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.60195% CI: [0.44, 4.53]Fisher Exact
Comparison: Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.3695% CI: [0.46, 8.51]Fisher Exact
Comparison: Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.01, 10.24]Fisher Exact
Comparison: Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.59695% CI: [0.43, 4.66]Fisher Exact
Comparison: Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.55295% CI: [0.39, 6.24]Fisher Exact
Comparison: Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.61295% CI: [0.1, 131.03]Fisher Exact
Comparison: Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0, 19.66]Fisher Exact
Comparison: Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.02995% CI: [1.04, 14.32]Fisher Exact
Comparison: Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.14395% CI: [0.67, 11.36]Fisher Exact
Comparison: Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.07, 15.25]Fisher Exact
Comparison: Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.49295% CI: [0, 3.57]Fisher Exact
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF
Percentage of participant with response as defined by a \>=30%, \>=50%, \>=70%, and \>=90%, reduction in the daily average pain intensity NRS score from baseline, that was maintained for a minimum of 3 consecutive days following this original study day (reduction in pain was maintained for a minimum duration of 4 consecutive days). Daily average pain was assessed on 11-point NRS over the past 24 hours where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Lower scores indicate less pain intensity
Time frame: Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Missing values were imputed using LOCF method. Data was not summarized statistically at week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=30% reduction | 10.3 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=50% reduction | 3.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=70% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=30% reduction | 24.1 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=50% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=70% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=30% reduction | 44.8 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=50% reduction | 27.6 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=70% reduction | 3.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=30% reduction | 41.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=50% reduction | 27.6 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=70% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=90% reduction | 0.0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=30% reduction | 48.3 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=50% reduction | 34.5 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=70% reduction | 6.9 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=50% reduction | 23.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=30% reduction | 13.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=70% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=50% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=90% reduction | 3.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=70% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 1: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=90% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=30% reduction | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=30% reduction | 40.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=50% reduction | 10.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=30% reduction | 30.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=70% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=50% reduction | 23.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 2: >=90% reduction | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 8: >=70% reduction | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=30% reduction | 40.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 6: >=70% reduction | 3.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF | Week 4: >=50% reduction | 16.7 percentage of participants |
Comparison: Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.1, 4.94]Fisher Exact
Comparison: Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.23, 3.32]Fisher Exact
Comparison: Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.05, 6.35]Fisher Exact
Comparison: Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.79595% CI: [0.38, 3.88]Fisher Exact
Comparison: Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.3695% CI: [0.46, 8.51]Fisher Exact
Comparison: Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.01, 10.24]Fisher Exact
Comparison: Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.33, 3.39]Fisher Exact
Comparison: Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.77195% CI: [0.33, 4.83]Fisher Exact
Comparison: Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.61295% CI: [0.1, 131.03]Fisher Exact
Comparison: Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0, 19.66]Fisher Exact
Comparison: Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.18795% CI: [0.66, 7.3]Fisher Exact
Comparison: Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.39995% CI: [0.48, 6.43]Fisher Exact
Comparison: Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 195% CI: [0.07, 15.25]Fisher Exact
Comparison: Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.49295% CI: [0, 3.57]Fisher Exact
Secondary
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time frame: Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Missing values were imputed using BOCF method. Here overall number of participants analyzed signifies participants who were evaluable for this measure. Data was not summarized statistically at Week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 2 | 0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 6 | 14.8 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 4 | 7.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 8 | 11.1 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 1 | 3.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 8 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 1 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 2 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 4 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF | Week 6 | 7.7 percentage of participants |
Comparison: Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.72495% CI: [0.03, 12.27]Fisher Exact
Comparison: Week 2: P-value was calculated using Fisher Extract method.p-value: 0.947Fisher Exact
Comparison: Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.63495% CI: [0.03, 8.71]Fisher Exact
Comparison: Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.97595% CI: [0.14, 7.74]Fisher Exact
Comparison: Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.75995% CI: [0.12, 18.86]Fisher Exact
Secondary
Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF
The Patient's Global Assessment of Cancer Pain was a global evaluation that utilized a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor), where higher score represented more pain.
Time frame: Week 1, 2, 4, 6, 8, 12, 16
Population: ITT population. Missing values were imputed using BOCF method. Here overall number of participants analyzed signifies participants who were evaluable for this measure. Data was not summarized statistically at Week 12 and 16 because post Week 8 participants were eligible to roll-over into extension study A4091029 (NCT00830180).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 2 | 0 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 6 | 14.8 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 4 | 7.4 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 8 | 14.8 percentage of participants |
| Tanezumab | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 1 | 3.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 8 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 1 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 2 | 7.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 4 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF | Week 6 | 7.7 percentage of participants |
Comparison: Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.72495% CI: [0.03, 12.27]Fisher Exact
Comparison: Week 2: P-value was calculated using Fisher Extract test.p-value: 0.95Fisher Exact
Comparison: Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.63495% CI: [0.03, 8.71]Fisher Exact
Comparison: Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.97595% CI: [0.14, 7.74]Fisher Exact
Comparison: Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.p-value: 0.57895% CI: [0.17, 23.89]Fisher Exact
Secondary
Vital Sign Examination: Blood Pressure (BP)
Systolic BP: the measurement of the pressure when the heart is contracted (systole). The systolic pressure indicates the maximum amount of work/force the heart has to perform with each stroke in order to move blood through the arteries. Diastolic BP: the pressure in the large arteries during the relaxation of the left ventricle. The diastolic pressure indicates the amount of pressure the heart must overcome in order to generate the next beat.
Time frame: Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies participants who were evaluable for this measure; number analyzed=participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Baseline Sitting Systolic BP | 125.4 millimeter of mercury (mmHg) | Standard Deviation 12.12 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 2 Sitting Systolic BP | 121.9 millimeter of mercury (mmHg) | Standard Deviation 12.87 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 4 Sitting Systolic BP | 121.4 millimeter of mercury (mmHg) | Standard Deviation 13.13 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 6 Sitting Systolic BP | 117.9 millimeter of mercury (mmHg) | Standard Deviation 13.33 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 12 Sitting Systolic BP | 120.4 millimeter of mercury (mmHg) | Standard Deviation 12.31 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 16 Sitting Systolic BP | 124.0 millimeter of mercury (mmHg) | Standard Deviation 10.58 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Early Termination Sitting Systolic BP | 114.5 millimeter of mercury (mmHg) | Standard Deviation 16.36 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Baseline Sitting Diastolic BP | 73.7 millimeter of mercury (mmHg) | Standard Deviation 8.71 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 2 Sitting Diastolic BP | 73.9 millimeter of mercury (mmHg) | Standard Deviation 8.07 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 4 Sitting Diastolic BP | 74.1 millimeter of mercury (mmHg) | Standard Deviation 9.48 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 6 Sitting Diastolic BP | 71.7 millimeter of mercury (mmHg) | Standard Deviation 9.55 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 12 Sitting Diastolic BP | 74.2 millimeter of mercury (mmHg) | Standard Deviation 8.07 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Week 16 Sitting Diastolic BP | 78.8 millimeter of mercury (mmHg) | Standard Deviation 9.09 |
| Tanezumab | Vital Sign Examination: Blood Pressure (BP) | Early Termination Sitting Diastolic BP | 72.2 millimeter of mercury (mmHg) | Standard Deviation 13.26 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 6 Sitting Diastolic BP | 75.3 millimeter of mercury (mmHg) | Standard Deviation 9.63 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Baseline Sitting Systolic BP | 120.6 millimeter of mercury (mmHg) | Standard Deviation 12.23 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Baseline Sitting Diastolic BP | 75.0 millimeter of mercury (mmHg) | Standard Deviation 7.49 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 2 Sitting Systolic BP | 123.2 millimeter of mercury (mmHg) | Standard Deviation 14.05 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 16 Sitting Diastolic BP | 80.2 millimeter of mercury (mmHg) | Standard Deviation 7.22 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 4 Sitting Systolic BP | 121.8 millimeter of mercury (mmHg) | Standard Deviation 15.56 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 2 Sitting Diastolic BP | 75.6 millimeter of mercury (mmHg) | Standard Deviation 11.9 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 6 Sitting Systolic BP | 124.8 millimeter of mercury (mmHg) | Standard Deviation 14.38 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 12 Sitting Diastolic BP | 78.4 millimeter of mercury (mmHg) | Standard Deviation 3.51 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 12 Sitting Systolic BP | 125.4 millimeter of mercury (mmHg) | Standard Deviation 11.39 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 4 Sitting Diastolic BP | 73.2 millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Week 16 Sitting Systolic BP | 129.0 millimeter of mercury (mmHg) | Standard Deviation 17.38 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Early Termination Sitting Diastolic BP | 72.9 millimeter of mercury (mmHg) | Standard Deviation 9.93 |
| Placebo | Vital Sign Examination: Blood Pressure (BP) | Early Termination Sitting Systolic BP | 122.0 millimeter of mercury (mmHg) | Standard Deviation 17.12 |
Secondary
Vital Sign Examination: Body Temperature
Time frame: Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here N (number of participants analyzed) signifies the participants who were evaluable for this measure. n=participants evaluable at specific time points for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Vital Sign Examination: Body Temperature | Week 4 | 36.7 degrees Celsius | Standard Deviation 0.18 |
| Tanezumab | Vital Sign Examination: Body Temperature | Week 12 | 36.7 degrees Celsius | Standard Deviation 0.18 |
| Tanezumab | Vital Sign Examination: Body Temperature | Week 2 | 36.7 degrees Celsius | Standard Deviation 0.19 |
| Tanezumab | Vital Sign Examination: Body Temperature | Week 16 | 36.6 degrees Celsius | Standard Deviation 0.16 |
| Tanezumab | Vital Sign Examination: Body Temperature | Week 6 | 36.6 degrees Celsius | Standard Deviation 0.24 |
| Tanezumab | Vital Sign Examination: Body Temperature | Early Termination | 36.7 degrees Celsius | Standard Deviation 0.18 |
| Tanezumab | Vital Sign Examination: Body Temperature | Baseline | 36.7 degrees Celsius | Standard Deviation 0.18 |
| Placebo | Vital Sign Examination: Body Temperature | Early Termination | 36.6 degrees Celsius | Standard Deviation 0.35 |
| Placebo | Vital Sign Examination: Body Temperature | Baseline | 36.6 degrees Celsius | Standard Deviation 0.25 |
| Placebo | Vital Sign Examination: Body Temperature | Week 2 | 36.6 degrees Celsius | Standard Deviation 0.27 |
| Placebo | Vital Sign Examination: Body Temperature | Week 4 | 36.6 degrees Celsius | Standard Deviation 0.21 |
| Placebo | Vital Sign Examination: Body Temperature | Week 6 | 36.7 degrees Celsius | Standard Deviation 0.26 |
| Placebo | Vital Sign Examination: Body Temperature | Week 12 | 36.6 degrees Celsius | Standard Deviation 0.14 |
| Placebo | Vital Sign Examination: Body Temperature | Week 16 | 36.7 degrees Celsius | Standard Deviation 0.15 |
Secondary
Vital Sign Examination: Heart Rate
Heart rate is the number of heart beats per minute.
Time frame: Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, and Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies participants who were evaluable for this measure. Number analyzed=participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Vital Sign Examination: Heart Rate | Week 2 | 80.4 beats per minute | Standard Deviation 13.1 |
| Tanezumab | Vital Sign Examination: Heart Rate | Week 12 | 78.2 beats per minute | Standard Deviation 11.02 |
| Tanezumab | Vital Sign Examination: Heart Rate | Week 4 | 78.5 beats per minute | Standard Deviation 10.56 |
| Tanezumab | Vital Sign Examination: Heart Rate | Week 16 | 85.3 beats per minute | Standard Deviation 8.87 |
| Tanezumab | Vital Sign Examination: Heart Rate | Baseline | 82.1 beats per minute | Standard Deviation 12.1 |
| Tanezumab | Vital Sign Examination: Heart Rate | Early Termination | 79.2 beats per minute | Standard Deviation 8.57 |
| Tanezumab | Vital Sign Examination: Heart Rate | Week 6 | 77.4 beats per minute | Standard Deviation 10.01 |
| Placebo | Vital Sign Examination: Heart Rate | Early Termination | 82.9 beats per minute | Standard Deviation 17.26 |
| Placebo | Vital Sign Examination: Heart Rate | Baseline | 82.6 beats per minute | Standard Deviation 12.85 |
| Placebo | Vital Sign Examination: Heart Rate | Week 4 | 79.7 beats per minute | Standard Deviation 12.23 |
| Placebo | Vital Sign Examination: Heart Rate | Week 6 | 80.1 beats per minute | Standard Deviation 15.22 |
| Placebo | Vital Sign Examination: Heart Rate | Week 12 | 72.9 beats per minute | Standard Deviation 10.04 |
| Placebo | Vital Sign Examination: Heart Rate | Week 16 | 75.8 beats per minute | Standard Deviation 12.94 |
| Placebo | Vital Sign Examination: Heart Rate | Week 2 | 81.3 beats per minute | Standard Deviation 14.11 |
Secondary
Vital Sign Examination: Respiratory Rate
Respiration rate measured as number of breaths taken per minute.
Time frame: Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo). Here overall number of participants analyzed signifies participants who were evaluable for this measure. Number analyzed=participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab | Vital Sign Examination: Respiratory Rate | Week 4 | 15.6 breaths per minute | Standard Deviation 3.46 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Week 12 | 14.7 breaths per minute | Standard Deviation 3.71 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Week 2 | 16.0 breaths per minute | Standard Deviation 3.52 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Week 16 | 15.1 breaths per minute | Standard Deviation 2.64 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Week 6 | 15.9 breaths per minute | Standard Deviation 3.28 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Early Termination | 16.4 breaths per minute | Standard Deviation 3.29 |
| Tanezumab | Vital Sign Examination: Respiratory Rate | Baseline | 15.5 breaths per minute | Standard Deviation 2.92 |
| Placebo | Vital Sign Examination: Respiratory Rate | Early Termination | 16.7 breaths per minute | Standard Deviation 2.78 |
| Placebo | Vital Sign Examination: Respiratory Rate | Baseline | 16.9 breaths per minute | Standard Deviation 2.61 |
| Placebo | Vital Sign Examination: Respiratory Rate | Week 2 | 16.8 breaths per minute | Standard Deviation 3.01 |
| Placebo | Vital Sign Examination: Respiratory Rate | Week 4 | 16.0 breaths per minute | Standard Deviation 3.04 |
| Placebo | Vital Sign Examination: Respiratory Rate | Week 6 | 16.1 breaths per minute | Standard Deviation 2.96 |
| Placebo | Vital Sign Examination: Respiratory Rate | Week 12 | 14.4 breaths per minute | Standard Deviation 2.99 |
| Placebo | Vital Sign Examination: Respiratory Rate | Week 16 | 14.0 breaths per minute | Standard Deviation 2.45 |